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Post-prandial Glycaemic Controlling Effects of BSG in Singapore Adults With Metabolic Syndrome

Primary Purpose

Metabolic Syndrome, Diabetes, Diet Modification

Status

Recruiting

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

autoclaved BSG-containing biscuits

bio-transformed BSG-containing biscuits

control biscuits

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, middle-aged and older adults, Post-prandial Glycaemic response, bio-transformed food

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female participants, aged 35-85 years old
English-literate and able to give informed consent in English
Willing to follow the study procedures
Meet any 3 of the 5 following NCEP-ATP III MetS criteria: waist circumference > 102 cm (male), > 88 cm (female) (For Asian population: Waist circumference > 90 cm (male), > 80 cm (female)); fasting glucose concentration ≥ 100 mg/dL or on medication; triglyceride ≥ 150 mg/dL or on medication; high density lipoprotein cholesterol (HDL) < 40 mg/dL (male), < 50 mg/dL (female); systolic or diastolic blood pressure > 130/85 mmHg or on medication);

Exclusion Criteria:

Significant change in weight (≥ 3 kg body weight) during the past 3 months
Allergy to barley, wheat, corn, egg, or other ingredients found inside the biscuits.
Acute illness at the study baseline
Exercising vigorously* over the past 3 months. *Defined as having > 6 metabolic equivalents of exercise daily; approximately 20 mins of moderate intensity exercise (e.g. slow jogging) a day
Following any restricted diet (e.g. vegetarian)
Smoking
Have a daily intake of more than 2 alcoholic drinks per day
Taking dietary supplements or food which may impact the outcome of interests (e.g. fermented foods, probiotic supplement etc.)
Consumption of antibiotics over past 3 months.
Pregnant, lactating, or planning pregnancy in the next 6 months
Insufficient venous access to allow the blood collection
Prescribed and taking antihypertensive/cholesterol-lowering/ type-2 diabetic medication which started less than 3 years prior to the intervention participation
High current intake of fibre* from brown rice or wholemeal products. *High, moderate or low intake taken as ≥ 6 servings, 4 - 5 servings, and ≤ 3 servings daily respectively based on My Healthy Plate guidelines
High current intake of fibre* from vegetables. * High, moderate or low intake taken as ≥ 2 servings, 2 servings, and ≤ 1 serving respectively based on My Healthy Plate guidelines

Sites / Locations

Yujing XuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Control biscuits group

autoclaved BSG-containing group

bio-transformed BSG-containing group

Arm Description

For each MTT, subjects are to consume 90 g control biscuits as their breakfast within 15 mins.

For each MTT, subjects are to consume 90 g autoclaved BSG-containing biscuits as their breakfast within 15 mins.

For each MTT, subjects are to consume 90 g bio-transformed BSG-containing biscuits as their breakfast within 15 mins.

Outcomes

Primary Outcome Measures

Change in blood glucose concentration

Glucose concentration in the blood will be measured

Change in blood insulin concentration

Insulin concentration in the blood will be measured

Change in blood triglyceride concentration

Triglyceride concentration in the blood will be measured

Change in blood cholesterol concentration

Total cholesterol concentration in the blood will be measured

Change in blood Low-density Lipoprotein-cholesterol (LDL) concentration

Low-density Lipoprotein-cholesterol concentration in the blood will be measured

Change in High-density Lipoprotein-cholesterol (HDL) concentration

High-density Lipoprotein-cholesterol concentration in the blood will be measured

Change in blood amino acid concentration

Amino acid concentration in the blood will be measured

Secondary Outcome Measures

Change in appetite assessed by visual analogue scale

Visual analogue scale will be used to assess appetite.

Change in breath CH4 and H2 concentrations

CH4 and H2 concentrations will be measured by breath analyzer

Change in weight and height

Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2

Change in waist circumference

Waist circumference (in cm) will be measured

Change in blood pressure

Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor.

Full Information

NCT ID

NCT05421780

First Posted

May 30, 2022

Last Updated

September 28, 2022

Sponsor

National University of Singapore

Collaborators

Ministry of Education, Singapore

1. Study Identification

Unique Protocol Identification Number

NCT05421780

Brief Title

Post-prandial Glycaemic Controlling Effects of BSG in Singapore Adults With Metabolic Syndrome

Official Title

Impact of Brewer's Spent Grain (BSG) and Bio-transformed BSG Biscuits on Post-prandial Glycaemic Controlling Effects in Singapore Adults With Metabolic Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 29, 2022 (Actual)

Primary Completion Date

October 2022 (Anticipated)

Study Completion Date

May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National University of Singapore

Collaborators

Ministry of Education, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of this study is to assess the glycaemic controlling effects of BSG and bio-transformed BSG-containing biscuits in Singapore adults with MetS. The investigators hypothesized that consumption of BSG and bio-transformed BSG containing biscuit will improve glycaemic control.

Detailed Description

This is a double-blind, randomised, crossover experiment. During the 3-week, 19 subjects will participate in a 3 meal tolerance test (MTT). During each MTT session, all subjects are required to consume 90 g biscuits (either control, autoclaved BSG or bio-transformed BSG biscuits) and monitored over a period of 240 minutes. All three types of biscuits will be consumed at a randomised sequence during this 3-week period. Post-prandial blood glucose, insulin, lipid and amino acid responses, breath analysis, body composition, blood pressure, appetite assessment, and any other glycaemic biomarkers will be assessed.

6. Conditions and Keywords

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

Metabolic Syndrome, Diabetes, Diet Modification

Keywords

Metabolic Syndrome, middle-aged and older adults, Post-prandial Glycaemic response, bio-transformed food

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

19 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control biscuits group

Arm Type

Placebo Comparator

Arm Description

For each MTT, subjects are to consume 90 g control biscuits as their breakfast within 15 mins.

Arm Title

autoclaved BSG-containing group

Arm Type

Experimental

Arm Description

For each MTT, subjects are to consume 90 g autoclaved BSG-containing biscuits as their breakfast within 15 mins.

Arm Title

bio-transformed BSG-containing group

Arm Type

Experimental

Arm Description

For each MTT, subjects are to consume 90 g bio-transformed BSG-containing biscuits as their breakfast within 15 mins.

Intervention Type

Dietary Supplement

Intervention Name(s)

autoclaved BSG-containing biscuits

Intervention Description

Consumption of autoclaved BSG-containing biscuits as breakfast.

Intervention Type

Dietary Supplement

Intervention Name(s)

bio-transformed BSG-containing biscuits

Intervention Description

Consumption of bio-transformed BSG-containing biscuits as breakfast.

Intervention Type

Dietary Supplement

Intervention Name(s)

control biscuits

Intervention Description

Consumption of plain biscuits as breakfast.

Primary Outcome Measure Information:

Title

Change in blood glucose concentration

Description

Glucose concentration in the blood will be measured

Time Frame

Every week (week 1, week 2 and week 3)

Title

Change in blood insulin concentration

Description

Insulin concentration in the blood will be measured

Time Frame

Every week (week 1, week 2 and week 3)

Title

Change in blood triglyceride concentration

Description

Triglyceride concentration in the blood will be measured

Time Frame

Every week (week 1, week 2 and week 3)

Title

Change in blood cholesterol concentration

Description

Total cholesterol concentration in the blood will be measured

Time Frame

Every week (week 1, week 2 and week 3)

Title

Change in blood Low-density Lipoprotein-cholesterol (LDL) concentration

Description

Low-density Lipoprotein-cholesterol concentration in the blood will be measured

Time Frame

Every week (week 1, week 2 and week 3)

Title

Change in High-density Lipoprotein-cholesterol (HDL) concentration

Description

High-density Lipoprotein-cholesterol concentration in the blood will be measured

Time Frame

Every week (week 1, week 2 and week 3)

Title

Change in blood amino acid concentration

Description

Amino acid concentration in the blood will be measured

Time Frame

Every week (week 1, week 2 and week 3)

Secondary Outcome Measure Information:

Title

Change in appetite assessed by visual analogue scale

Description

Visual analogue scale will be used to assess appetite.

Time Frame

Every week (week 1, week 2 and week 3)

Title

Change in breath CH4 and H2 concentrations

Description

CH4 and H2 concentrations will be measured by breath analyzer

Time Frame

Every week (week 1, week 2 and week 3)

Title

Change in weight and height

Description

Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2

Time Frame

Every week (week 1, week 2 and week 3)

Title

Change in waist circumference

Description

Waist circumference (in cm) will be measured

Time Frame

Every week (week 1, week 2 and week 3)

Title

Change in blood pressure

Description

Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor.

Time Frame

Every week (week 1, week 2 and week 3)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female participants, aged 35-85 years old English-literate and able to give informed consent in English Willing to follow the study procedures Meet any 3 of the 5 following NCEP-ATP III MetS criteria: waist circumference > 102 cm (male), > 88 cm (female) (For Asian population: Waist circumference > 90 cm (male), > 80 cm (female)); fasting glucose concentration ≥ 100 mg/dL or on medication; triglyceride ≥ 150 mg/dL or on medication; high density lipoprotein cholesterol (HDL) < 40 mg/dL (male), < 50 mg/dL (female); systolic or diastolic blood pressure > 130/85 mmHg or on medication); Exclusion Criteria: Significant change in weight (≥ 3 kg body weight) during the past 3 months Allergy to barley, wheat, corn, egg, or other ingredients found inside the biscuits. Acute illness at the study baseline Exercising vigorously* over the past 3 months. *Defined as having > 6 metabolic equivalents of exercise daily; approximately 20 mins of moderate intensity exercise (e.g. slow jogging) a day Following any restricted diet (e.g. vegetarian) Smoking Have a daily intake of more than 2 alcoholic drinks per day Taking dietary supplements or food which may impact the outcome of interests (e.g. fermented foods, probiotic supplement etc.) Consumption of antibiotics over past 3 months. Pregnant, lactating, or planning pregnancy in the next 6 months Insufficient venous access to allow the blood collection Prescribed and taking antihypertensive/cholesterol-lowering/ type-2 diabetic medication which started less than 3 years prior to the intervention participation High current intake of fibre* from brown rice or wholemeal products. *High, moderate or low intake taken as ≥ 6 servings, 4 - 5 servings, and ≤ 3 servings daily respectively based on My Healthy Plate guidelines High current intake of fibre* from vegetables. * High, moderate or low intake taken as ≥ 2 servings, 2 servings, and ≤ 1 serving respectively based on My Healthy Plate guidelines

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yujing Xu

Phone

98853979

e0554129@u.nus.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jung Eun Kim

Organizational Affiliation

Food Science and technology, Faculty of Science, National University of Singapore

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yujing Xu

City

Singapore

ZIP/Postal Code

117543

Country

Singapore

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

yujing xu

Phone

98853979

e0554129@u.nus.edu

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Electronic copies of the data with identifiable participant information will be kept on a secure website with access limited to Dr. Kim and Dr. Kim's research staff. All data will be de-identified prior to statistical analyses.

Learn more about this trial

Post-prandial Glycaemic Controlling Effects of BSG in Singapore Adults With Metabolic Syndrome

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