Clinical trial NCT05298111: 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
Overall status: COMPLETED
Phase: NA
Conditions: At Risk of Type 2 Diabetes Mellitus
Keywords: Melon Manis Terengganu peel
Glycemic response
Perceived satiety
Food intake
At risk of type 2 diabetes
Lead sponsor: Universiti Sultan Zainal Abidin
Sponsor class: OTHER
Collaborators: name: National University of Malaysia
name: Universiti Sains Malaysia
First posted: 2022-03-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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).
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Blood Glucose Levels
timeFrame: Baseline (0 min), 30, 60, 90 and 120 minutes on Day 1 and Day 4 of both study visits
Secondary outcomes:
measure: Perceived Satiety (Area Under the Curve)
timeFrame: Day 1 and 4 of both study visits
measure: Food Intake
timeFrame: Day 1 and 4 of both study visits
measure: Calories Intake
timeFrame: Day 1 and day 4 of both study visits
Other outcomes:
measure: Body Weight (kg)
timeFrame: Day 1 and 4 of both study visits
measure: Height (cm)
timeFrame: Day 1 and 4 of both study visits
measure: Body Mass Index (BMI) (kg/m^2)
timeFrame: Day 1 and 4 of both study visits
measure: % Body Fat
timeFrame: Day 1 and 4 of both study visits
measure: Waist Circumference (cm)
timeFrame: Day 1 and 4 of both study visits
measure: Blood Pressure
timeFrame: Day 1 and 4 of both study visits
Locations:
city: Kuala Terengganu
country: Malaysia
facility: Food Preparation and Therapeutic Diet Lab, Faculty of Health Sciences, Universiti Sultan Zainal Abidin, Gong Badak Campus
state: Terengganu
Study officials:
affiliation: Universiti Sultan Zainal Abidin
name: Prof Dr Sakinah Harith
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Sultan Zainal Abidin
name: Dr Norshazila Shahidan
role: PRINCIPAL_INVESTIGATOR
affiliation: National University of Malaysia
name: Prof Madya Dr Mohd Razif Shahril
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Sains Malaysia
name: Prof Madya Dr Hermizi Hapidin
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.