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

NCT05298111 | Completed Results

• 1 other identifier: RCTOYQ
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Perceived Satiety (Area Under the Curve)

  Day 1 and 4 of both study visits

• Food Intake

  Day 1 and 4 of both study visits

• Calories Intake

  Day 1 and day 4 of both study visits

Other Outcomes (6)

• Body Weight (kg)

  Day 1 and 4 of both study visits

• Height (cm)

  Day 1 and 4 of both study visits

• Body Mass Index (BMI) (kg/m^2)

  Day 1 and 4 of both study visits

Study Arms (2)

Formulation 3

ACTIVE COMPARATOR

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

Other: Formulation 3

Control

PLACEBO COMPARATOR

Glucose

Other: Control

Interventions

Formulation 3 OTHER

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

Also known as: Formulated MMT peel powder

Formulation 3

Control OTHER

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

Also known as: Glucose

Control

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sultan Zainal Abidin: lead
• National University of Malaysia: collaborator
• Universiti Sains Malaysia: collaborator

Study Sites (1)

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

Kuala Terengganu, Terengganu, 21300, Malaysia

Location

Related Publications (3)

• 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.

  PMID: 24726414 BACKGROUND

• 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.

  PMID: 27956737 BACKGROUND

• 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.

  PMID: 35941609 DERIVED

Related Links

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

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Limitations and Caveats

Since this is an acute feeding study, thus the acute findings cannot translate to a long-term benefit. Next, due to limitations in budgeting, the biochemical parameters such as serum insulin, lipid profiles and appetite hormones were not assessed. Therefore, satiety was only measured using subjective means instead of assessed by physiological markers.

Results Point of Contact

• Title: Ms Ong Ying Qian
• Organization: Universiti Sultan Zainal Abidin

oyq0109@gmail.com

+60142186195

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 28, 2022
• Study Start: October 1, 2021
• Primary Completion: November 3, 2021
• Study Completion: November 3, 2021
• Last Updated: August 15, 2024
• Results First Posted: August 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)