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

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

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.

Study Overview

• Status: Completed
• Conditions: At Risk of Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: Formulation 3; Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Terengganu
    • Kuala Terengganu, Terengganu, Malaysia, 21300
      • Food Preparation and Therapeutic Diet Lab, Faculty of Health Sciences, Universiti Sultan Zainal Abidin, Gong Badak Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (0 min), 30, 60, 90 and 120 minutes on Day 1 and Day 4 of both study visits

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Day 1 and 4 of both study visits
Calories 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 day 4 of both study visits

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight (kg)	Body weight was taken at every study visit.	Day 1 and 4 of both study visits
Height (cm)	Height was taken at every study visit.	Day 1 and 4 of both study visits
Body Mass Index (BMI) (kg/m^2)	BMI was calculated using formula = body weight (kg)/height (m)^2	Day 1 and 4 of both study visits
% Body Fat	% body fat was taken at every study visit.	Day 1 and 4 of both study visits
Waist Circumference (cm)	Waist circumference was taken at every study visit.	Day 1 and 4 of both study visits
Blood Pressure	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.	Day 1 and 4 of both study visits

Collaborators and Investigators

• Sponsor: Universiti Sultan Zainal Abidin
• Collaborators: Universiti Sains Malaysia; National University of Malaysia
• Investigators: Principal Investigator: Prof Dr Sakinah Harith, Universiti Sultan Zainal Abidin; Principal Investigator: Dr Norshazila Shahidan, Universiti Sultan Zainal Abidin; Principal Investigator: Prof Madya Dr Mohd Razif Shahril, National University of Malaysia; Principal Investigator: Prof Madya Dr Hermizi Hapidin, Universiti Sains Malaysia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Malaysian Adult Nutrition Survey (MANS). Volume I: Methodology and general findings

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): November 3, 2021
• Study Completion (Actual): November 3, 2021

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Food intake; Glycemic response; Melon Manis Terengganu peel; Perceived satiety; At risk of type 2 diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: RCTOYQ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No