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Completed

NCT Number: NCT05298111

Acute Effect of MMT 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.

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Key information

Conditions

At Risk of Type 2 Diabetes Mellitus

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Kuala Terengganu, Terengganu, 21300, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Formulated MMT peel powder

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

Other names: Glucose

Primary outcomes

  1. Blood Glucose Levels

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

    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.

Secondary outcomes

  1. Perceived Satiety (Area Under the Curve)

    Time frame: Day 1 and 4 of both study visits

    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.

  2. Food Intake

    Time frame: Day 1 and 4 of both study visits

    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.

  3. Calories Intake

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

    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.

Other outcomes

  1. Body Weight (kg)

    Time frame: Day 1 and 4 of both study visits

    Body weight was taken at every study visit.

  2. Height (cm)

    Time frame: Day 1 and 4 of both study visits

    Height was taken at every study visit.

  3. Body Mass Index (BMI) (kg/m^2)

    Time frame: Day 1 and 4 of both study visits

    BMI was calculated using formula = body weight (kg)/height (m)^2

  4. % Body Fat

    Time frame: Day 1 and 4 of both study visits

    % body fat was taken at every study visit.

  5. Waist Circumference (cm)

    Time frame: Day 1 and 4 of both study visits

    Waist circumference was taken at every study visit.

  6. Blood Pressure

    Time frame: Day 1 and 4 of both study visits

    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.

Sponsors and collaborators

Lead sponsor

Universiti Sultan Zainal Abidin

Other

Collaborators

  • National University of Malaysia
  • Universiti Sains Malaysia

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 28, 2022
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.