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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05298111

Enrollment

Registered

2022-03-28

Start date

2021-10-01

Completion date

2021-11-03

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERFormulation 3

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

OTHERControl

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

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).

Eligibility

Sex/Gender

ALL

Age

18 Years to 59 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Blood Glucose Levels	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

Measure	Time frame	Description
Perceived Satiety (Area Under the Curve)	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.
Food Intake	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.
Calories Intake	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

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

Countries

Malaysia

Participant flow

Recruitment details

120 participants were screened for eligibility between 18th August 2021 and 18th October 2021 in Kuala Nerus, Terengganu, Malaysia,

Pre-assignment details

36 of 120 participants were randomized. 84 participants did not meet inclusion criteria.

Participants by arm

Arm	Count
Formulation 3 Then Control Formulated MMT peel powder (provide 5 g dietary fiber per day) Respondents were consumed 36 g of Formulation 3 then 4.5 g of control, both containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast.	15
Control Then Formulation 3 Glucose Control: Respondents were consumed 4.5 g of control then 36 g of Formulation 3, both containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast	15
Total	30

Withdrawals & dropouts

Period	Reason	FG000	FG001
Washout (3 Days)	Withdrawal by Subject	3	3

Baseline characteristics

Characteristic	Control Then Formulation 3	Total	Formulation 3 Then Control
Age, Continuous	37.9 years STANDARD_DEVIATION 6.8	36.1 years STANDARD_DEVIATION 8.7	35.7 years STANDARD_DEVIATION 4.5
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment Malaysia	15 Participants	30 Participants	15 Participants
Sex: Female, Male Female	12 Participants	23 Participants	11 Participants
Sex: Female, Male Male	3 Participants	7 Participants	4 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Formulation 3	Blood Glucose Levels	0 min	5.6 mmol/L	Standard Deviation 0.4
Formulation 3	Blood Glucose Levels	60 min	7.4 mmol/L	Standard Deviation 1
Formulation 3	Blood Glucose Levels	30 min	6.7 mmol/L	Standard Deviation 0.6
Formulation 3	Blood Glucose Levels	120 min	6.5 mmol/L	Standard Deviation 0.6
Formulation 3	Blood Glucose Levels	90 min	6.9 mmol/L	Standard Deviation 0.8
Control	Blood Glucose Levels	120 min	6.1 mmol/L	Standard Deviation 0.6
Control	Blood Glucose Levels	90 min	7.0 mmol/L	Standard Deviation 1
Control	Blood Glucose Levels	0 min	5.7 mmol/L	Standard Deviation 0.4
Control	Blood Glucose Levels	30 min	7.7 mmol/L	Standard Deviation 0.7
Control	Blood Glucose Levels	60 min	8.2 mmol/L	Standard Deviation 1.2

p-value: <0.001ANCOVA

Secondary

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.

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

Arm	Measure	Value (MEDIAN)
Formulation 3	Calories Intake	1796 kcal
Control	Calories Intake	1893 kcal

p-value: 0.001Sign test

Secondary