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| Name | Class |
|---|---|
| National University of Malaysia | OTHER |
| Universiti Sains Malaysia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation 3 | Active Comparator | Formulated MMT peel powder (provide 5 g dietary fiber per day) |
|
| Control | Placebo Comparator | Glucose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Satiety (Area Under the Curve) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight (kg) | Body weight was taken at every study visit. | Day 1 and 4 of both study visits |
| Height (cm) | Height was taken at every study visit. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Food Preparation and Therapeutic Diet Lab, Faculty of Health Sciences, Universiti Sultan Zainal Abidin, Gong Badak Campus | Kuala Terengganu | Terengganu | 21300 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24726414 | Background | 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. | |
| 27956737 |
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36 of 120 participants were randomized. 84 participants did not meet inclusion criteria.
120 participants were screened for eligibility between 18th August 2021 and 18th October 2021 in Kuala Nerus, Terengganu, Malaysia,
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout (3 Days) |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Control Then Formulation 3 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mmol/L | Baseline (0 min), 30, 60, 90 and 120 minutes on Day 1 and Day 4 of both study visits |
|
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All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored or assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Formulation 3 | Formulated MMT peel powder (provide 5 g dietary fiber per day) 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 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ms Ong Ying Qian | Universiti Sultan Zainal Abidin | +60142186195 | oyq0109@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 25, 2022 | Mar 25, 2022 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2022 | Mar 25, 2022 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 1, 2022 | Mar 15, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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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).
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|
| 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 |
|
|
| Day 1 and 4 of both study visits |
| Food 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. | Day 1 and 4 of both study visits |
| 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. | Day 1 and day 4 of both study visits |
| Day 1 and 4 of both study visits |
| Body Mass Index (BMI) (kg/m^2) | BMI was calculated using formula = body weight (kg)/height (m)^2 | Day 1 and 4 of both study visits |
| % Body Fat | % body fat was taken at every study visit. | Day 1 and 4 of both study visits |
| Waist Circumference (cm) | Waist circumference was taken at every study visit. | Day 1 and 4 of both study visits |
| Blood Pressure | 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. | Day 1 and 4 of both study visits |
| 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. |
| 35941609 | Derived | 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. |
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| NOT COMPLETED |
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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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Perceived Satiety (Area Under the Curve) | 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. | Posted | Mean | Standard Error | score on a scale*min | Day 1 and 4 of both study visits |
|
|
|
|
| Secondary | Food 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. | Posted | Median | Full Range | g | Day 1 and 4 of both study visits |
|
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|
| 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. | Posted | Median | Full Range | kcal | Day 1 and day 4 of both study visits |
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| Other Pre-specified | Body Weight (kg) | Body weight was taken at every study visit. | Posted | Mean | Standard Deviation | kg | Day 1 and 4 of both study visits |
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| Other Pre-specified | Height (cm) | Height was taken at every study visit. | Posted | Mean | Standard Deviation | cm | Day 1 and 4 of both study visits |
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| Other Pre-specified | Body Mass Index (BMI) (kg/m^2) | BMI was calculated using formula = body weight (kg)/height (m)^2 | Posted | Mean | Standard Deviation | kg/m^2 | Day 1 and 4 of both study visits |
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| Other Pre-specified | % Body Fat | % body fat was taken at every study visit. | Posted | Mean | Standard Deviation | Percentage | Day 1 and 4 of both study visits |
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| Other Pre-specified | Waist Circumference (cm) | Waist circumference was taken at every study visit. | Posted | Mean | Standard Deviation | cm | Day 1 and 4 of both study visits |
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| Other Pre-specified | Blood Pressure | 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. | Posted | Median | Standard Deviation | mmHg | Day 1 and 4 of both study visits |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control | Glucose Control: Respondents were consumed 4.5 g of control containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast | 0 | 0 | 0 | 0 | 0 | 0 |
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| Desire to eat |
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| Prospective food consumption |
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| Thirstiness |
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| Fat |
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| Dietary fiber |
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