Trial Outcomes & Findings for Acute Effect of MMT Peel Powder on Glycemic Response, Satiety, and Food Intake in Adults at Risk for Type 2 Diabetes (NCT NCT05298111)
NCT ID: NCT05298111
Last Updated: 2024-08-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Baseline (0 min), 30, 60, 90 and 120 minutes on Day 1 and Day 4 of both study visits
Results posted on
2024-08-15
Participant Flow
120 participants were screened for eligibility between 18th August 2021 and 18th October 2021 in Kuala Nerus, Terengganu, Malaysia,
36 of 120 participants were randomized. 84 participants did not meet inclusion criteria.
Participant milestones
| Measure |
Formulation 3, Then Control
Participants first consumed 36 g of Formulated MMT peel powder containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast. After a washout period of 3 days, they then consumed 4.5 g glucose containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast.
|
Control, Then Formulation 3
Participants first consumed 4.5 of glucose containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast. After a washout period of 3 days, they then consumed 36 g formulated MMT peel powder containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast.
|
|---|---|---|
|
First Intervention
STARTED
|
18
|
18
|
|
First Intervention
COMPLETED
|
18
|
18
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout (3 Days)
STARTED
|
18
|
18
|
|
Washout (3 Days)
COMPLETED
|
15
|
15
|
|
Washout (3 Days)
NOT COMPLETED
|
3
|
3
|
|
Second Intervention
STARTED
|
15
|
15
|
|
Second Intervention
COMPLETED
|
15
|
15
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Formulation 3, Then Control
Participants first consumed 36 g of Formulated MMT peel powder containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast. After a washout period of 3 days, they then consumed 4.5 g glucose containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast.
|
Control, Then Formulation 3
Participants first consumed 4.5 of glucose containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast. After a washout period of 3 days, they then consumed 36 g formulated MMT peel powder containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast.
|
|---|---|---|
|
Washout (3 Days)
Withdrawal by Subject
|
3
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Formulation 3 Then Control
n=15 Participants
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.
|
Control Then Formulation 3
n=15 Participants
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
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 4.5 • n=15 Participants
|
37.9 years
STANDARD_DEVIATION 6.8 • n=15 Participants
|
36.1 years
STANDARD_DEVIATION 8.7 • n=30 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=15 Participants
|
12 Participants
n=15 Participants
|
23 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=15 Participants
|
3 Participants
n=15 Participants
|
7 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Malaysia
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
30 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline (0 min), 30, 60, 90 and 120 minutes on Day 1 and Day 4 of both study visitsBlood 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.
Outcome measures
| Measure |
Formulation 3
n=30 Participants
Respondents were consumed 36 g of Formulation 3 containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
Control
n=30 Participants
Respondents were consumed 4.5 g of control containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
|---|---|---|
|
Blood Glucose Levels
60 min
|
7.4 mmol/L
Standard Deviation 1.0
|
8.2 mmol/L
Standard Deviation 1.2
|
|
Blood Glucose Levels
0 min
|
5.6 mmol/L
Standard Deviation 0.4
|
5.7 mmol/L
Standard Deviation 0.4
|
|
Blood Glucose Levels
30 min
|
6.7 mmol/L
Standard Deviation 0.6
|
7.7 mmol/L
Standard Deviation 0.7
|
|
Blood Glucose Levels
90 min
|
6.9 mmol/L
Standard Deviation 0.8
|
7.0 mmol/L
Standard Deviation 1.0
|
|
Blood Glucose Levels
120 min
|
6.5 mmol/L
Standard Deviation 0.6
|
6.1 mmol/L
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Day 1 and 4 of both study visitsPerceived 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.
Outcome measures
| Measure |
Formulation 3
n=30 Participants
Respondents were consumed 36 g of Formulation 3 containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
Control
n=30 Participants
Respondents were consumed 4.5 g of control containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
|---|---|---|
|
Perceived Satiety (Area Under the Curve)
Hunger
|
200.5 score on a scale*min
Standard Error 22.3
|
277 score on a scale*min
Standard Error 32.4
|
|
Perceived Satiety (Area Under the Curve)
Fullness
|
912 score on a scale*min
Standard Error 34
|
822.5 score on a scale*min
Standard Error 41.6
|
|
Perceived Satiety (Area Under the Curve)
Desire to eat
|
231 score on a scale*min
Standard Error 21.9
|
329 score on a scale*min
Standard Error 32.4
|
|
Perceived Satiety (Area Under the Curve)
Prospective food consumption
|
263 score on a scale*min
Standard Error 31
|
344.5 score on a scale*min
Standard Error 35
|
|
Perceived Satiety (Area Under the Curve)
Thirstiness
|
486.5 score on a scale*min
Standard Error 51.5
|
499.5 score on a scale*min
Standard Error 45.1
|
SECONDARY outcome
Timeframe: Day 1 and 4 of both study visitsThe 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.
Outcome measures
| Measure |
Formulation 3
n=30 Participants
Respondents were consumed 36 g of Formulation 3 containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
Control
n=30 Participants
Respondents were consumed 4.5 g of control containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
|---|---|---|
|
Food Intake
Carbohydrate
|
219.3 g
Interval 163.3 to 334.5
|
225.2 g
Interval 143.2 to 371.6
|
|
Food Intake
Protein
|
74.1 g
Interval 52.2 to 106.4
|
75.3 g
Interval 55.0 to 112.3
|
|
Food Intake
Fat
|
74.3 g
Interval 46.7 to 108.9
|
77.2 g
Interval 50.3 to 118.5
|
|
Food Intake
Dietary fiber
|
10.9 g
Interval 8.2 to 13.9
|
6.1 g
Interval 2.7 to 10.4
|
SECONDARY outcome
Timeframe: Day 1 and day 4 of both study visitsThe 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.
Outcome measures
| Measure |
Formulation 3
n=30 Participants
Respondents were consumed 36 g of Formulation 3 containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
Control
n=30 Participants
Respondents were consumed 4.5 g of control containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
|---|---|---|
|
Calories Intake
|
1796 kcal
Interval 1424.0 to 2569.0
|
1893 kcal
Interval 1434.0 to 2476.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 and 4 of both study visitsBody weight was taken at every study visit.
Outcome measures
| Measure |
Formulation 3
n=30 Participants
Respondents were consumed 36 g of Formulation 3 containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
Control
n=30 Participants
Respondents were consumed 4.5 g of control containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
|---|---|---|
|
Body Weight (kg)
|
75.1 kg
Standard Deviation 14.9
|
75.1 kg
Standard Deviation 15.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 and 4 of both study visitsHeight was taken at every study visit.
Outcome measures
| Measure |
Formulation 3
n=30 Participants
Respondents were consumed 36 g of Formulation 3 containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
Control
n=30 Participants
Respondents were consumed 4.5 g of control containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
|---|---|---|
|
Height (cm)
|
158.6 cm
Standard Deviation 6.3
|
158.6 cm
Standard Deviation 6.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 and 4 of both study visitsBMI was calculated using formula = body weight (kg)/height (m)\^2
Outcome measures
| Measure |
Formulation 3
n=30 Participants
Respondents were consumed 36 g of Formulation 3 containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
Control
n=30 Participants
Respondents were consumed 4.5 g of control containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
|---|---|---|
|
Body Mass Index (BMI) (kg/m^2)
|
29.8 kg/m^2
Standard Deviation 5.1
|
29.8 kg/m^2
Standard Deviation 5.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 and 4 of both study visits% body fat was taken at every study visit.
Outcome measures
| Measure |
Formulation 3
n=30 Participants
Respondents were consumed 36 g of Formulation 3 containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
Control
n=30 Participants
Respondents were consumed 4.5 g of control containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
|---|---|---|
|
% Body Fat
|
38.9 Percentage
Standard Deviation 8.1
|
39.0 Percentage
Standard Deviation 8.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 and 4 of both study visitsWaist circumference was taken at every study visit.
Outcome measures
| Measure |
Formulation 3
n=30 Participants
Respondents were consumed 36 g of Formulation 3 containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
Control
n=30 Participants
Respondents were consumed 4.5 g of control containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
|---|---|---|
|
Waist Circumference (cm)
|
91.2 cm
Standard Deviation 11.0
|
91.0 cm
Standard Deviation 11.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 and 4 of both study visitsBlood 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.
Outcome measures
| Measure |
Formulation 3
n=30 Participants
Respondents were consumed 36 g of Formulation 3 containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
Control
n=30 Participants
Respondents were consumed 4.5 g of control containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
|
|---|---|---|
|
Blood Pressure
systolic blood pressure
|
124 mmHg
Standard Deviation 14
|
122 mmHg
Standard Deviation 15
|
|
Blood Pressure
diastolic blood pressure
|
77 mmHg
Standard Deviation 9
|
75 mmHg
Standard Deviation 9
|
Adverse Events
Formulation 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place