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Acute Effect of MMT Peel Powder on Glycemic Response, Satiety, and Food Intake in Adults at Risk for Type 2 Diabetes

Primary Purpose

At Risk of Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Formulation 3
Control
Sponsored by
Universiti Sultan Zainal Abidin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for At Risk of Type 2 Diabetes Mellitus focused on measuring Melon Manis Terengganu peel, Glycemic response, Perceived satiety, Food intake, At risk of type 2 diabetes

Eligibility Criteria

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

Inclusion Criteria:

  • Modified Finnish Type 2 Diabetes Risk Assessment Tool (FINDRISC) score ≥ 4
  • Capillary fasting blood glucose (FBG) < 7.0 mmol/L
  • Malaysian
  • Live, work or study in Kuala Nerus, Terengganu
  • Both gender
  • Age 18 to 59 years old
  • Non-smoker
  • Those taking supplement agree to undergo washout period of one week

Exclusion Criteria:

  • Had clinical history of type 2 diabetes mellitus (T2DM)
  • Capillary FBG ≥ 7.0 mmol/L
  • Take oral antidiabetic agents
  • Participate in other weight management programme or interventional research
  • On a prescribed medical diet
  • GI illnesses or conditions
  • Allergy or sensitivity to study products
  • Pregnant, currently breastfeeding, or planning to become pregnant
  • On dietary restrictions
  • Smoker

Sites / Locations

  • Food Preparation and Therapeutic Diet Lab, Faculty of Health Sciences, Universiti Sultan Zainal Abidin, Gong Badak Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Formulation 3

Control

Arm Description

Formulated MMT peel powder (provide 5 g dietary fiber per day)

Glucose

Outcomes

Primary Outcome Measures

Changes in fasting and postprandial blood glucose
Blood glucose were measured using glucometer (Accu Chek Performa, New South Wales, Australia) from finger-prick blood samples according to the standard operating procedure at baseline (0 min), 30, 60, 90 and 120 minutes.

Secondary Outcome Measures

Changes in perceived satiety
Perceived satiety measurements were rated using a 10-cm visual analogue scale (VAS) which consisted of hunger (How hungry are you?), fullness (How full are you?), desire to eat (How strong is your desire to eat?), prospective food consumption (How much would you be able to eat right now?) and thirstiness (How thirsty are you?) (Tey, Salleh, Henry, & Forde, 2017). The scale ranged from 0 (not at all) to 10 (very much) measured at baseline (0 min), 30, 60, 90 and 120 minutes.
Changes in food intake
The respondents were asked to record all the food or drink they had consumed including sauces, soup and gravies using household measures once they woke up in the morning until they went to sleep at night.

Full Information

First Posted
March 1, 2022
Last Updated
March 16, 2022
Sponsor
Universiti Sultan Zainal Abidin
Collaborators
National University of Malaysia, Universiti Sains Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05298111
Brief Title
Acute Effect of MMT Peel Powder on Glycemic Response, Satiety, and Food Intake in Adults at Risk for Type 2 Diabetes
Official Title
Acute Effect of Melon Manis Terengganu Peel Powder on Glycemic Response, Satiety, and Food Intake in Adults at Risk for Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
November 3, 2021 (Actual)
Study Completion Date
November 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sultan Zainal Abidin
Collaborators
National University of Malaysia, Universiti Sains Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Open-label, randomised, placebo-controlled, crossover study with two intervention arms. The study was conducted in 30 respondents and the primary objective is to show an improved glycemic response after Melon Manis Terengganu (MMT) peel powder consumption in people at risk of type 2 diabetes.
Detailed Description
The main aim of the study is to investigate the acute effect of MMT peel powder on glycemic response in people at risk of type 2 diabetes. Besides, the acute effect of MMT peel powder on perceived satiety and energy intake were explored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
At Risk of Type 2 Diabetes Mellitus
Keywords
Melon Manis Terengganu peel, Glycemic response, Perceived satiety, Food intake, At risk of type 2 diabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The respondents consumed Formulation 3 (A) and control (B) with study breakfast based on randomly assigned treatment sequences (AB, BA). Each visit was separated with three days washout period and lasted about 3 hour (starting around 8 am and finishing at approximately 11 am).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Formulation 3
Arm Type
Active Comparator
Arm Description
Formulated MMT peel powder (provide 5 g dietary fiber per day)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Glucose
Intervention Type
Other
Intervention Name(s)
Formulation 3
Other Intervention Name(s)
Formulated MMT peel powder
Intervention Description
Respondents were consumed 36 g of Formulation 3 containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Glucose
Intervention Description
Respondents were consumed 4.5 g of control containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
Primary Outcome Measure Information:
Title
Changes in fasting and postprandial blood glucose
Description
Blood glucose were measured using glucometer (Accu Chek Performa, New South Wales, Australia) from finger-prick blood samples according to the standard operating procedure at baseline (0 min), 30, 60, 90 and 120 minutes.
Time Frame
Day 1 and 4 of both study visits
Secondary Outcome Measure Information:
Title
Changes in perceived satiety
Description
Perceived satiety measurements were rated using a 10-cm visual analogue scale (VAS) which consisted of hunger (How hungry are you?), fullness (How full are you?), desire to eat (How strong is your desire to eat?), prospective food consumption (How much would you be able to eat right now?) and thirstiness (How thirsty are you?) (Tey, Salleh, Henry, & Forde, 2017). The scale ranged from 0 (not at all) to 10 (very much) measured at baseline (0 min), 30, 60, 90 and 120 minutes.
Time Frame
Day 1 and 4 of both study visits
Title
Changes in food intake
Description
The respondents were asked to record all the food or drink they had consumed including sauces, soup and gravies using household measures once they woke up in the morning until they went to sleep at night.
Time Frame
Day 1 and 4 of both study visits
Other Pre-specified Outcome Measures:
Title
Changes in body weight (kg)
Description
Body weight was taken at every study visit.
Time Frame
Day 1 and 4 of both study visits
Title
Changes in height (m)
Description
Height was taken at every study visit.
Time Frame
Day 1 and 4 of both study visits
Title
Changes in body mass index (BMI) (kg/m^2)
Description
BMI was calculated using formula = body weight (kg)/height (m)^2
Time Frame
Day 1 and 4 of both study visits
Title
Changes in % body fat
Description
% body fat was taken at every study visit.
Time Frame
Day 1 and 4 of both study visits
Title
Changes in waist circumference (cm)
Description
Waist circumference was taken at every study visit.
Time Frame
Day 1 and 4 of both study visits
Title
Changes in blood pressure
Description
Blood pressure was measured using an Omron automatic digital blood pressure monitor (Omron HEM-7221) in a seated position at all visits after 5 min of sitting.
Time Frame
Day 1 and 4 of both study visits
Title
Habitual food intake
Description
The respondents were instructed to complete a semi-quantitative Food Frequency Questionnaire (FFQ) which was adapted from the Malaysian Adult Nutrition Survey (MANS) (Institute for Public Health, 2014).
Time Frame
Day 0 before the first study visit start date
Title
Habitual physical activity
Description
The physical activity of the respondents was measured by using the International Physical Activity Questionnaire-Short Version (IPAQ-SF) in Malay language that had been pilot tested and pre validated in National Health and Morbidity Survey 2011 (Teh et al., 2014)
Time Frame
Day 0 before the first study visit start date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Modified Finnish Type 2 Diabetes Risk Assessment Tool (FINDRISC) score ≥ 4 Capillary fasting blood glucose (FBG) < 7.0 mmol/L Malaysian Live, work or study in Kuala Nerus, Terengganu Both gender Age 18 to 59 years old Non-smoker Those taking supplement agree to undergo washout period of one week Exclusion Criteria: Had clinical history of type 2 diabetes mellitus (T2DM) Capillary FBG ≥ 7.0 mmol/L Take oral antidiabetic agents Participate in other weight management programme or interventional research On a prescribed medical diet GI illnesses or conditions Allergy or sensitivity to study products Pregnant, currently breastfeeding, or planning to become pregnant On dietary restrictions Smoker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof Dr Sakinah Harith
Organizational Affiliation
Universiti Sultan Zainal Abidin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Norshazila Shahidan
Organizational Affiliation
Universiti Sultan Zainal Abidin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prof Madya Dr Mohd Razif Shahril
Organizational Affiliation
National University of Malaysia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prof Madya Dr Hermizi Hapidin
Organizational Affiliation
Universiti Sains Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Food Preparation and Therapeutic Diet Lab, Faculty of Health Sciences, Universiti Sultan Zainal Abidin, Gong Badak Campus
City
Kuala Terengganu
State/Province
Terengganu
ZIP/Postal Code
21300
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24726414
Citation
Teh CH, Lim KK, Chan YY, Lim KH, Azahadi O, Hamizatul Akmar AH, Ummi Nadiah Y, Syafinaz MS, Kee CC, Yeo PS, Fadhli Y. The prevalence of physical activity and its associated factors among Malaysian adults: findings from the National Health and Morbidity Survey 2011. Public Health. 2014 May;128(5):416-23. doi: 10.1016/j.puhe.2013.10.008. Epub 2014 Apr 13.
Results Reference
result
PubMed Identifier
27956737
Citation
Tey SL, Salleh NB, Henry J, Forde CG. Effects of aspartame-, monk fruit-, stevia- and sucrose-sweetened beverages on postprandial glucose, insulin and energy intake. Int J Obes (Lond). 2017 Mar;41(3):450-457. doi: 10.1038/ijo.2016.225. Epub 2016 Dec 13.
Results Reference
result
PubMed Identifier
35941609
Citation
Ong YQ, Harith S, Shahril MR, Shahidan N, Hapidin H. Acute effect of Melon Manis Terengganu peel powder on glycemic response, perceived satiety, and food intake: a randomized, placebo-controlled crossover trial in adults at risk of type 2 diabetes. BMC Nutr. 2022 Aug 8;8(1):75. doi: 10.1186/s40795-022-00572-1.
Results Reference
derived
Links:
URL
https://iku.moh.gov.my/images/IKU/Document/REPORT/NHMS2014-MANS-VOLUME-1-MethodologyandGeneralFind.pdf
Description
Malaysian Adult Nutrition Survey (MANS). Volume I: Methodology and general findings

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Acute Effect of MMT Peel Powder on Glycemic Response, Satiety, and Food Intake in Adults at Risk for Type 2 Diabetes

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