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

Universiti Sultan Zainal Abidin36 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

At Risk of Type 2 Diabetes Mellitus

Interventions

Formulation 3OTHER

Respondents were consumed 36 g of Formulation 3 containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast

ControlOTHER

Respondents were consumed 4.5 g of control containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Kuala Terengganu, Terengganu, Malaysia

Outcomes

Primary Outcomes

Blood Glucose Levels

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: Baseline (0 min), 30, 60, 90 and 120 minutes on Day 1 and Day 4 of both study visits

Secondary Outcomes

Perceived Satiety (Area Under the Curve)

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. The area under the curve was calculated using trapezoid rule.

Time frame: Day 1 and 4 of both study visits

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.

Time frame: Day 1 and 4 of both study visits

Calories Intake

Time frame: Day 1 and day 4 of both study visits

Data from ClinicalTrials.gov

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