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

NCT ID: NCT05298111

Last Updated: 2024-08-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2021-11-03

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.

Conditions

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At Risk of Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Formulation 3

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

Group Type ACTIVE_COMPARATOR

Formulation 3

Intervention Type OTHER

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

Control

Glucose

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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Formulated MMT peel powder Glucose

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National University of Malaysia

OTHER

Sponsor Role collaborator

Universiti Sains Malaysia

OTHER

Sponsor Role collaborator

Universiti Sultan Zainal Abidin

OTHER

Sponsor Role lead

Responsible Party

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Ong Ying Qian

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prof Dr Sakinah Harith

Role: PRINCIPAL_INVESTIGATOR

Universiti Sultan Zainal Abidin

Dr Norshazila Shahidan

Role: PRINCIPAL_INVESTIGATOR

Universiti Sultan Zainal Abidin

Prof Madya Dr Mohd Razif Shahril

Role: PRINCIPAL_INVESTIGATOR

National University of Malaysia

Prof Madya Dr Hermizi Hapidin

Role: PRINCIPAL_INVESTIGATOR

Universiti Sains Malaysia

Locations

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

Kuala Terengganu, Terengganu, Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type BACKGROUND
PMID: 24726414 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27956737 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35941609 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://iku.moh.gov.my/images/IKU/Document/REPORT/NHMS2014-MANS-VOLUME-1-MethodologyandGeneralFind.pdf

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

Other Identifiers

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RCTOYQ

Identifier Type: -

Identifier Source: org_study_id

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