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Effects of Antioxidant Sugar vs Granulated Sugar on Metabolic Outcomes in Healthy and Cardio Metabolic Subjects (MSS)

Primary Purpose

Gene Expression, Cardiometabolic Risk, Metabolic Syndrome

Status

Terminated

Phase

Not Applicable

Locations

Malaysia

Study Type

Interventional

Intervention

Study 1: MRBS

Study 2: White sugar & education module

Study 2: MRBS & education module

About this trial

This is an interventional other trial for Gene Expression focused on measuring Antioxidant sugar, Gene Expression, Cardio metabolic risks, Education tool

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Study 1:

Inclusion Criteria:

Willingness to adhere to study protocol
Healthy adults to be aged between 18 and 60 years in both genders
Being non-smoker
Body mass index (BMI) between 23 - 26.9 kg/m2 (overweight).

Exclusion Criteria:

Present of any kidney, liver and/or inflammatory disease (inflammatory bowel disease, Rheumatoid arthritis and etc.), thyroid disorder, diabetes (Type 1 & Type 2), cardiovascular or metabolic disease
Individuals with impaired glucose tolerance or with fasting blood glucose level that more than 5.2 mmol/L
Pregnancy or lactation
Alcohol consumption, food allergy
Individuals who are on regular antioxidant, anti-inflammatory and /or anti-obesity drugs, receiving any glucose lowering and/or lipid lowering medications
Change in the diet and physical activity (significant weight changes during study period)
Subjects who habitually consumed beverages rich in sugar such as milo, Teh tarik more than 500 ml, (as tested with the FFQ)

Study 2:

Candidates will be screened for:

Cardiometabolic risk factors (waist circumference, blood pressure, fasting blood glucose, triglyceride and high-density lipoprotein cholesterol)
Pregnancy or breast feeding
Mental health status
Daily total sugar intake

Inclusion Criteria:

Malaysian, aged ≥18-59 years old
Able to read, write and communicate well either in Malay or English
Attained at least formal education level (secondary school and above)
Able to use the gadgets and have access to the internet
Presence with Cardiometabolic risk defines at least any of three out of five risk factors are present and the risk factors are:waist circumference (men: ≥90cm, women:≥80 cm); blood pressure (≥130/85 mmHg); having diabetes mellitus or fasting blood sugar (≥5.6mmol/L); triglyceride (≥1.7 mmol/L) or high-density lipoprotein (men: <1.03 mmol/L, women: <1.3 mmol/L).
Daily free sugar intake ≥10% of the daily energy intake

Exclusion Criteria:

Unstable mental health referring to the DASS-21 score for Depression score ≥5; Anxiety score ≥4 and Stress score ≥8 (Ramli, Salmiah, Nurul Ain 2009)
Uncontrolled type 2 diabetes defines as HbA1c of more than 8% or hypertriglyceridemia of > 10 mmol/L
Presence with chronic diseases-related complications such as liver disease or stage 3 chronic kidney disease
Reported abnormal thyroid stimulating hormones
On current dietary program or medication for weight loss
On cancer therapy
Having physical disabilities
Pregnancy or the desire to become pregnant in the next 3 months

Sites / Locations

Universiti Putra Malaysia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

No Intervention

Experimental

Arm Label

Study 1: Normal sugar

Study 1:Minimally refined brown sugar (MRBS)

Study 2: Normal sugar intake

Study 2: White sugar

Study 2: MRBS

Arm Description

Control group will be required to continue consuming normal sugar intake for 8 weeks.

Intervention group will be required to consume MRBS as added sugar based on their habitual diet for 8 weeks intervention.

- The control group will have no intervention and will continue with their normal daily intake for six months.

Intervention group I will be advised to reduce sugar intake to no more than 10% from total energy intake. Intervention group I will be given white sugar for daily usage. Participants in this group will be exposed to the nutrition education module (45 minutes per session, once a week) for six months, attend lecture classes and communicate with health educators through communication applications. For the first three months, one-to-one diet counseling will be conducted. Participants' intake of free sugar, as well as other nutrients (carbohydrate, protein, fats, fibre and others) will be closely monitored to ensure compliance to dietary recommendations.

Intervention group II will be advised to reduce sugar intake to no more than 10% from total energy intake. Intervention group II will be given MRBS for daily usage. Participants in this group will be exposed to the nutrition education module (45 minutes per session, once a week) for six months, attend lecture classes and communicate with health educators through communication applications. For the first three months, one-to-one diet counseling will be conducted. Participants' intake of free sugar, as well as other nutrients (carbohydrate, protein, fats, fibre and others) will be closely monitored to ensure compliance to dietary recommendations.

Outcomes

Primary Outcome Measures

Study 1: Gene expression of inflammation biomarkers (interleukin-6)

Change from baseline in gene expression of interleukin-6 in micrograms at 8th weeks.

Study 1: Gene expression of inflammation biomarkers (TNF-α)

Change from baseline in gene expression of TNF-α in picograms per milliliter at 8th weeks.

Study 1: Gene expression of inflammation biomarkers (CPR)

Change from baseline in gene expression of CPR in milligram per liter at 8th weeks.

Study 1: Gene expression of oxidative stress biomarkers (MDA)

Change from baseline in gene expression of MDA in millimolar at 8th weeks.

Study 1: Gene expression of oxidative stress biomarkers (SOD)

Change from baseline in gene expression of SOD in Units per milliliter at 8th weeks.

Study 1: Gene expression of oxidative stress biomarkers (CAT)

Change from baseline in gene expression of CAT in nanomoles at 8th weeks.

Study 2: Change from baseline in sugar consumption

Dietary sugar intake will be determined using a 3-day food record and semi-quantitative FFQ of added sugar intake. Total sugar (grams per day) in foods will be calculated using formula [(total sugar (grams) - natural sugar (grams)]. The total added sugar intake will be divided into four centiles i.e., 25th percentile [<10.3g (2 tsps.)], 50th percentile [10.3-23.8g (2-5 tsps.)], 75th percentile [23.8-47.0g (5-9 tsps.)] and 100th percentiles [>47g (9 tsps.)].

Study 2: Change from baseline in sugar consumption

Secondary Outcome Measures

Study 1: Inflammation biomarkers (interleukin-6)

Change from baseline in interleukin-6 in micrograms at 8th weeks.

Study 1: Inflammation biomarkers (TNF-α)

Change from baseline in TNF-α in picograms per milliliter at 8th weeks.

Study 1: Inflammation biomarkers (CPR)

Change from baseline in CPR in milligram per liter at 8th weeks.

Study 1: Oxidative stress biomarkers (MDA)

Change from baseline in MDA in millimolar at 8th weeks.

Study 1: Oxidative stress biomarkers (SOD)

Change from baseline in SOD in Units per milliliter at 8th weeks.

Study 1: Oxidative stress biomarkers (CAT)

Change from baseline in CAT in nanomoles at 8th weeks.

Study 1: TAC

Change from baseline in TAC in millimolar at 8th weeks.

Study 1: Blood pressure

Change from baseline in blood pressure in mmHg at 8th weeks.

Study 1: Lipid profile

Change from baseline in total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mmol/L at 8th weeks.

Study 1: Glucose profile

Change from baseline in fasting glucose in mmol/L at 8th weeks.

Study 1: Anthropometric measurements (height)

Change from baseline in height in meters at 8th weeks.

Study 1: Anthropometric measurements (weight)

Change from baseline in weight in kilograms at 8th weeks.

Study 1: Anthropometric measurements (waist circumference)

Change from baseline in waist circumference in centimeters at 8th weeks.

Study 1: Anthropometric measurements (hip circumference)

Change from baseline in hip circumference in centimeters at 8th weeks.

Study 1: Body mass index

Weight (kg) and height (m) will be combined to report body mass index in kg/m2.

Study 1: Waist hip ratio

Waist (cm) and hip circumference (cm) will be combined to report waist hip ratio

Study 1: Change from baseline in sugar consumption at 8th weeks

Study 1: Change from baseline in physical activity level at 8th weeks

- Physical activity level will be measured using International Physical Activity Questionnaire (IPAQ) and results will be categorized as low, moderate and high physical activity.

Study 1: Change from baseline in intensity of physical activity at 8th weeks

Metabolic Equivalent Task (minutes/week) will be used to assess the intensity of physical activity.

Study 2: Change from baseline in anthropometric measurements (height)

Height in meters will be taken.

Study 2: Change from baseline in anthropometric measurements (weight)

Weight in meters will be taken.

Study 2: Change from baseline in anthropometric measurements (waist circumference)

Waist circumference in centimeters will be taken.

Study 2: Change from baseline in anthropometric measurements (hip circumference)

Hip circumference in centimeters will be taken.

Study 2: Change from baseline in body mass index

Weight (kg) and height (m) will be combined to report body mass index in kg/m2.

Study 2: Change from baseline in waist hip ratio

Waist (cm) and hip circumference (cm) will be combined to report waist hip ratio.

Study 2: Change from baseline in blood pressure

Blood pressure in mmHg will be taken.

Study 2: Change from baseline in lipid profile

Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mmol/L will be measured.

Study 2: Change from baseline in sugar profile

Fasting glucose in mmol/L will be measured.

Study 2: Change from baseline in antioxidant activity

Antioxidant activity in mmol/L will be measured.

Study 2: Change from baseline in 24-hour urinary sucrose/fructose

Urinary sucrose (mg/day) and fructose (mg/day) will be combined to report 24-hour urinary sucrose/fructose.

Study 2: Change from baseline in knowledge level

Knowledge level of healthy diet and sugar will be tested using Knowledge Assessment Questionnaire. The score will be presented in percentage.

Study 2: Change from baseline in health belief

Health belief model construct will be determined using Health Belief Model questionnaire. Five subscales: perceived susceptibility, perceived severity, perceived benefits, perceived barriers and perceived self-efficacy will be measured and the scores will be presented in percentage.

Study 2: Change from baseline in mental health

Mental health status will be measured using DASS-21 questionnaire, measuring depression (normal cut-off point: 0-4), anxiety (normal cut-off point: 0-3) and stress (normal cut-off point: 0-7).

Study 2: Change from baseline in physical activity level

Physical activity level will be measured using International Physical Activity Questionnaire (IPAQ) and results will be categorized as low, moderate and high physical activity.

Study 2: Change from baseline in intensity of physical activity

Metabolic Equivalent Task (minutes/week) will be used to assess the intensity of physical activity.

Study 2: Change from baseline in anthropometric measurements (weight)

Weight in meters will be taken.

Study 2: Change from baseline in anthropometric measurements (height)

Height in meters will be taken.

Study 2: Change from baseline in anthropometric measurements (waist circumference)

Waist circumference in centimeters will be taken.

Study 2: Change from baseline in anthropometric measurements (hip circumference)

Hip circumference in centimeters will be taken.

Study 2: Change from baseline in body mass index

Weight (kg) and height (m) will be combined to report body mass index in kg/m2.

Study 2: Change from baseline in waist hip ratio

Waist (cm) and hip circumference (cm) will be combined to report waist hip ratio.

Study 2: Change from baseline in blood pressure

Blood pressure in mmHg will be taken.

Study 2: Change from baseline in lipid profile

Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mmol/L will be measured.

Study 2: Change from baseline in sugar profile

Fasting glucose in mmol/L will be measured.

Study 2: Change from baseline in antioxidant activity

Antioxidant activity in mmol/L will be measured.

Study 2: Change from baseline in 24-hour urinary sucrose/fructose

Urinary sucrose (mg/day) and fructose (mg/day) will be combined to report 24-hour urinary sucrose/fructose.

Study 2: Change from baseline in knowledge level

Knowledge level of healthy diet and sugar will be tested using Knowledge Assessment Questionnaire. The score will be presented in percentage.

Study 2: Change from baseline in health belief

Study 2: Change from baseline in mental health

Mental health status will be measured using DASS-21 questionnaire, measuring depression (normal cut-off point: 0-4), anxiety (normal cut-off point: 0-3) and stress (normal cut-off point: 0-7).

Study 2: Change from baseline in physical activity level

Physical activity level will be measured using International Physical Activity Questionnaire (IPAQ) and results will be categorized as low, moderate and high physical activity.

Study 2: Change from baseline in intensity of physical activity

Metabolic Equivalent Task (minutes/week) will be used to assess the intensity of physical activity.

Full Information

NCT ID

NCT04737044

First Posted

January 15, 2021

Last Updated

February 6, 2023

Sponsor

Universiti Putra Malaysia

Collaborators

Central Sugars Refinery Sdn Bhd, Malaysia

1. Study Identification

Unique Protocol Identification Number

NCT04737044

Brief Title

Effects of Antioxidant Sugar vs Granulated Sugar on Metabolic Outcomes in Healthy and Cardio Metabolic Subjects

Acronym

MSS

Official Title

1: Effects of Antioxidant-rich Sugar as Alternative Compared to Granulated Sugar on Gene Expression and Other Metabolic Parameters in Healthy Subjects 2: Effectiveness of Education Module to Modify Sugar Consumption Among Individuals With Cardio Metabolic Risk

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Terminated

Why Stopped

Termination of study by the Sponsor (Central Sugars Refinery Sdn. Bhd. Malaysia)

Study Start Date

February 1, 2022 (Actual)

Primary Completion Date

June 1, 2022 (Actual)

Study Completion Date

July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universiti Putra Malaysia

Collaborators

Central Sugars Refinery Sdn Bhd, Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Study 1: To investigate the effects of antioxidant-rich sugar as alternative compared to granulated sugar on gene expression and other metabolic parameters in healthy subjects. The hypotheses is antioxidant-rich sugar have positive effects on reducing inflammatory cytokines, oxidative stress biomarkers and other metabolic parameters in intervention group compared to control group. Study 2: To evaluate the effectiveness of a nutrition education module in modifying sugar consumption and other CMR-related outcomes in individuals with cardiometabolic risk. The hypotheses is the nutrition education module significantly improves the sugar consumption and other CMR-related outcomes in the intervention groups compared to the control group

Detailed Description

Study 1: After being informed about the study and potential risks, written informed consent will be obtained from all subjects involved in the study. Respondents will be interviewed at Nutritional Status Assessments Lab at University of Putra, Malaysia (UPM) to obtain socio-demographic data, medical status, nutritional status, lifestyle practices and daily dietary intake. This study will be conducted for a period of 8 weeks. The study design is single-blinded parallel-randomized controlled trial (n=80), with 40 subjects in each group (one intervention and one control group). The participants will be selected based on the inclusion and exclusion criteria. Study 2: After being informed about the study and potential risks, written informed consent will be obtained from all subjects involved in the study prior to commencing the study. Respondents will be screened at Nutritional Status Assessments Lab at UPM for mental health status, daily sugar intake, cardiometabolic risk factors (waist circumference, blood pressure, fasting blood glucose, triglyceride and high-density lipoprotein cholesterol) where blood pressure and blood sample will be taken by the phlebotomist. Female candidates will be screened for pregnancy or breast feeding. Those who meet the inclusion/exclusion criteria will be selected. They will be informed via communication application whether they are eligible for the study. This study will be conducted for a period of 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gene Expression, Cardiometabolic Risk, Metabolic Syndrome

Keywords

Antioxidant sugar, Gene Expression, Cardio metabolic risks, Education tool

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Study 1: The study will be using a two-arm single-blinded RCT with 40 subjects in each of the intervention and control groups. Study 2: The study will be using a three-arm RCT with 23 subjects in each groups (two interventions and one control groups).

Masking

Participant

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study 1: Normal sugar

Arm Type

No Intervention

Arm Description

Control group will be required to continue consuming normal sugar intake for 8 weeks.

Arm Title

Study 1:Minimally refined brown sugar (MRBS)

Arm Type

Experimental

Arm Description

Intervention group will be required to consume MRBS as added sugar based on their habitual diet for 8 weeks intervention.

Arm Title

Study 2: Normal sugar intake

Arm Type

No Intervention

Arm Description

- The control group will have no intervention and will continue with their normal daily intake for six months.

Arm Title

Study 2: White sugar

Arm Type

Experimental

Arm Description

Arm Title

Study 2: MRBS

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Study 1: MRBS

Other Intervention Name(s)

Food-based and gene expression

Intervention Description

MRBS as added sugar based on their habitual diet

Intervention Type

Other

Intervention Name(s)

Study 2: White sugar & education module

Other Intervention Name(s)

Food-based and nutrition education study

Intervention Description

White sugar for daily usage (<10% daily energy intake)

Intervention Type

Other

Intervention Name(s)

Study 2: MRBS & education module

Other Intervention Name(s)

Food-based and nutrition education study

Intervention Description

MRBS for daily usage (<10% daily energy intake)

Primary Outcome Measure Information:

Title

Study 1: Gene expression of inflammation biomarkers (interleukin-6)

Description

Change from baseline in gene expression of interleukin-6 in micrograms at 8th weeks.

Time Frame

8 weeks

Title

Study 1: Gene expression of inflammation biomarkers (TNF-α)

Description

Change from baseline in gene expression of TNF-α in picograms per milliliter at 8th weeks.

Time Frame

8 weeks

Title

Study 1: Gene expression of inflammation biomarkers (CPR)

Description

Change from baseline in gene expression of CPR in milligram per liter at 8th weeks.

Time Frame

8 weeks

Title

Study 1: Gene expression of oxidative stress biomarkers (MDA)

Description

Change from baseline in gene expression of MDA in millimolar at 8th weeks.

Time Frame

8 weeks

Title

Study 1: Gene expression of oxidative stress biomarkers (SOD)

Description

Change from baseline in gene expression of SOD in Units per milliliter at 8th weeks.

Time Frame

8 weeks

Title

Study 1: Gene expression of oxidative stress biomarkers (CAT)

Description

Change from baseline in gene expression of CAT in nanomoles at 8th weeks.

Time Frame

8 weeks

Title

Study 2: Change from baseline in sugar consumption

Description

Time Frame

3 months

Title

Study 2: Change from baseline in sugar consumption

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Study 1: Inflammation biomarkers (interleukin-6)

Description

Change from baseline in interleukin-6 in micrograms at 8th weeks.

Time Frame

8 weeks

Title

Study 1: Inflammation biomarkers (TNF-α)

Description

Change from baseline in TNF-α in picograms per milliliter at 8th weeks.

Time Frame

8 weeks

Title

Study 1: Inflammation biomarkers (CPR)

Description

Change from baseline in CPR in milligram per liter at 8th weeks.

Time Frame

8 weeks

Title

Study 1: Oxidative stress biomarkers (MDA)

Description

Change from baseline in MDA in millimolar at 8th weeks.

Time Frame

8 weeks

Title

Study 1: Oxidative stress biomarkers (SOD)

Description

Change from baseline in SOD in Units per milliliter at 8th weeks.

Time Frame

8 weeks

Title

Study 1: Oxidative stress biomarkers (CAT)

Description

Change from baseline in CAT in nanomoles at 8th weeks.

Time Frame

8 weeks

Title

Study 1: TAC

Description

Change from baseline in TAC in millimolar at 8th weeks.

Time Frame

8 weeks

Title

Study 1: Blood pressure

Description

Change from baseline in blood pressure in mmHg at 8th weeks.

Time Frame

8 weeks

Title

Study 1: Lipid profile

Description

Change from baseline in total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mmol/L at 8th weeks.

Time Frame

8 weeks

Title

Study 1: Glucose profile

Description

Change from baseline in fasting glucose in mmol/L at 8th weeks.

Time Frame

8 weeks

Title

Study 1: Anthropometric measurements (height)

Description

Change from baseline in height in meters at 8th weeks.

Time Frame

8 weeks

Title

Study 1: Anthropometric measurements (weight)

Description

Change from baseline in weight in kilograms at 8th weeks.

Time Frame

8 weeks

Title

Study 1: Anthropometric measurements (waist circumference)

Description

Change from baseline in waist circumference in centimeters at 8th weeks.

Time Frame

8 weeks

Title

Study 1: Anthropometric measurements (hip circumference)

Description

Change from baseline in hip circumference in centimeters at 8th weeks.

Time Frame

8 weeks

Title

Study 1: Body mass index

Description

Weight (kg) and height (m) will be combined to report body mass index in kg/m2.

Time Frame

8 weeks

Title

Study 1: Waist hip ratio

Description

Waist (cm) and hip circumference (cm) will be combined to report waist hip ratio

Time Frame

8 weeks

Title

Study 1: Change from baseline in sugar consumption at 8th weeks

Description

Time Frame

8 weeks

Title

Study 1: Change from baseline in physical activity level at 8th weeks

Description

- Physical activity level will be measured using International Physical Activity Questionnaire (IPAQ) and results will be categorized as low, moderate and high physical activity.

Time Frame

8 weeks

Title

Study 1: Change from baseline in intensity of physical activity at 8th weeks

Description

Metabolic Equivalent Task (minutes/week) will be used to assess the intensity of physical activity.

Time Frame

8 weeks

Title

Study 2: Change from baseline in anthropometric measurements (height)

Description

Height in meters will be taken.

Time Frame

3 months

Title

Study 2: Change from baseline in anthropometric measurements (weight)

Description

Weight in meters will be taken.

Time Frame

3 months

Title

Study 2: Change from baseline in anthropometric measurements (waist circumference)

Description

Waist circumference in centimeters will be taken.

Time Frame

3 months

Title

Study 2: Change from baseline in anthropometric measurements (hip circumference)

Description

Hip circumference in centimeters will be taken.

Time Frame

3 months

Title

Study 2: Change from baseline in body mass index

Description

Weight (kg) and height (m) will be combined to report body mass index in kg/m2.

Time Frame

3 months

Title

Study 2: Change from baseline in waist hip ratio

Description

Waist (cm) and hip circumference (cm) will be combined to report waist hip ratio.

Time Frame

3 months

Title

Study 2: Change from baseline in blood pressure

Description

Blood pressure in mmHg will be taken.

Time Frame

3 months

Title

Study 2: Change from baseline in lipid profile

Description

Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mmol/L will be measured.

Time Frame

3 months

Title

Study 2: Change from baseline in sugar profile

Description

Fasting glucose in mmol/L will be measured.

Time Frame

3 months

Title

Study 2: Change from baseline in antioxidant activity

Description

Antioxidant activity in mmol/L will be measured.

Time Frame

3 months

Title

Study 2: Change from baseline in 24-hour urinary sucrose/fructose

Description

Urinary sucrose (mg/day) and fructose (mg/day) will be combined to report 24-hour urinary sucrose/fructose.

Time Frame

3 months

Title

Study 2: Change from baseline in knowledge level

Description

Knowledge level of healthy diet and sugar will be tested using Knowledge Assessment Questionnaire. The score will be presented in percentage.

Time Frame

3 months

Title

Study 2: Change from baseline in health belief

Description

Time Frame

3 months

Title

Study 2: Change from baseline in mental health

Description

Mental health status will be measured using DASS-21 questionnaire, measuring depression (normal cut-off point: 0-4), anxiety (normal cut-off point: 0-3) and stress (normal cut-off point: 0-7).

Time Frame

3 months

Title

Study 2: Change from baseline in physical activity level

Description

Physical activity level will be measured using International Physical Activity Questionnaire (IPAQ) and results will be categorized as low, moderate and high physical activity.

Time Frame

3 months

Title

Study 2: Change from baseline in intensity of physical activity

Description

Metabolic Equivalent Task (minutes/week) will be used to assess the intensity of physical activity.

Time Frame

3 months

Title

Study 2: Change from baseline in anthropometric measurements (weight)

Description

Weight in meters will be taken.

Time Frame

6 months

Title

Study 2: Change from baseline in anthropometric measurements (height)

Description

Height in meters will be taken.

Time Frame

6 months

Title

Study 2: Change from baseline in anthropometric measurements (waist circumference)

Description

Waist circumference in centimeters will be taken.

Time Frame

6 months

Title

Study 2: Change from baseline in anthropometric measurements (hip circumference)

Description

Hip circumference in centimeters will be taken.

Time Frame

6 months

Title

Study 2: Change from baseline in body mass index

Description

Weight (kg) and height (m) will be combined to report body mass index in kg/m2.

Time Frame

6 months

Title

Study 2: Change from baseline in waist hip ratio

Description

Waist (cm) and hip circumference (cm) will be combined to report waist hip ratio.

Time Frame

6 months

Title

Study 2: Change from baseline in blood pressure

Description

Blood pressure in mmHg will be taken.

Time Frame

6 months

Title

Study 2: Change from baseline in lipid profile

Description

Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mmol/L will be measured.

Time Frame

6 months

Title

Study 2: Change from baseline in sugar profile

Description

Fasting glucose in mmol/L will be measured.

Time Frame

6 months

Title

Study 2: Change from baseline in antioxidant activity

Description

Antioxidant activity in mmol/L will be measured.

Time Frame

6 months

Title

Study 2: Change from baseline in 24-hour urinary sucrose/fructose

Description

Urinary sucrose (mg/day) and fructose (mg/day) will be combined to report 24-hour urinary sucrose/fructose.

Time Frame

6 months

Title

Study 2: Change from baseline in knowledge level

Description

Knowledge level of healthy diet and sugar will be tested using Knowledge Assessment Questionnaire. The score will be presented in percentage.

Time Frame

6 months

Title

Study 2: Change from baseline in health belief

Description

Time Frame

6 months

Title

Study 2: Change from baseline in mental health

Description

Mental health status will be measured using DASS-21 questionnaire, measuring depression (normal cut-off point: 0-4), anxiety (normal cut-off point: 0-3) and stress (normal cut-off point: 0-7).

Time Frame

6 months

Title

Study 2: Change from baseline in physical activity level

Description

Physical activity level will be measured using International Physical Activity Questionnaire (IPAQ) and results will be categorized as low, moderate and high physical activity.

Time Frame

6 months

Title

Study 2: Change from baseline in intensity of physical activity

Description

Metabolic Equivalent Task (minutes/week) will be used to assess the intensity of physical activity.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

Study 1: Inclusion Criteria: Willingness to adhere to study protocol Healthy adults to be aged between 18 and 60 years in both genders Being non-smoker Body mass index (BMI) between 23 - 26.9 kg/m2 (overweight). Exclusion Criteria: Present of any kidney, liver and/or inflammatory disease (inflammatory bowel disease, Rheumatoid arthritis and etc.), thyroid disorder, diabetes (Type 1 & Type 2), cardiovascular or metabolic disease Individuals with impaired glucose tolerance or with fasting blood glucose level that more than 5.2 mmol/L Pregnancy or lactation Alcohol consumption, food allergy Individuals who are on regular antioxidant, anti-inflammatory and /or anti-obesity drugs, receiving any glucose lowering and/or lipid lowering medications Change in the diet and physical activity (significant weight changes during study period) Subjects who habitually consumed beverages rich in sugar such as milo, Teh tarik more than 500 ml, (as tested with the FFQ) Study 2: Candidates will be screened for: Cardiometabolic risk factors (waist circumference, blood pressure, fasting blood glucose, triglyceride and high-density lipoprotein cholesterol) Pregnancy or breast feeding Mental health status Daily total sugar intake Inclusion Criteria: Malaysian, aged ≥18-59 years old Able to read, write and communicate well either in Malay or English Attained at least formal education level (secondary school and above) Able to use the gadgets and have access to the internet Presence with Cardiometabolic risk defines at least any of three out of five risk factors are present and the risk factors are:waist circumference (men: ≥90cm, women:≥80 cm); blood pressure (≥130/85 mmHg); having diabetes mellitus or fasting blood sugar (≥5.6mmol/L); triglyceride (≥1.7 mmol/L) or high-density lipoprotein (men: <1.03 mmol/L, women: <1.3 mmol/L). Daily free sugar intake ≥10% of the daily energy intake Exclusion Criteria: Unstable mental health referring to the DASS-21 score for Depression score ≥5; Anxiety score ≥4 and Stress score ≥8 (Ramli, Salmiah, Nurul Ain 2009) Uncontrolled type 2 diabetes defines as HbA1c of more than 8% or hypertriglyceridemia of > 10 mmol/L Presence with chronic diseases-related complications such as liver disease or stage 3 chronic kidney disease Reported abnormal thyroid stimulating hormones On current dietary program or medication for weight loss On cancer therapy Having physical disabilities Pregnancy or the desire to become pregnant in the next 3 months

Facility Information:

Facility Name

Universiti Putra Malaysia

City

Serdang

State/Province

Selangor

ZIP/Postal Code

43400

Country

Malaysia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35623864

Citation

Chiang WL, Mohd Yusof BN, Azlan A, Ismail IZ, Abu Zaid Z. Impacts of a nutrition education intervention in individuals with cardiometabolic risk: Protocol of a randomized controlled trial. Clin Nutr ESPEN. 2022 Jun;49:536-543. doi: 10.1016/j.clnesp.2022.03.037. Epub 2022 Mar 31.

Results Reference

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Effects of Antioxidant Sugar vs Granulated Sugar on Metabolic Outcomes in Healthy and Cardio Metabolic Subjects

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