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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acute Effect of Melon Manis Terengganu Peel Powder on Glycemic Response, Satiety, and Food Intake in Adults at Risk for Type 2 Diabetes

Conditions
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At Risk of Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Formulation 3
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Formulation 3<br>Formulated MMT peel powder (provide 5 g dietary fiber per day) | Other: Formulation 3<br>* Respondents were consumed 36 g of Formulation 3 containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast<br>* Other names: Formulated MMT peel powder;|
| Placebo Comparator: Control<br>Glucose | Other: Control<br>* Respondents were consumed 4.5 g of control containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast<br>* Other names: Glucose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 and 4 of both study visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 and 4 of both study visits | 
| 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. | Day 1 and 4 of both study visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melon Manis Terengganu peel, Glycemic response, Perceived satiety, Food intake, At risk of type 2 diabetes