At Risk of Type 2 Diabetes MellitusNCT05298111
Acute Effect of MMT Peel Powder on Glycemic Response, Satiety, and Food Intake in Adults at Risk for Type 2 Diabetes
A study testing Formulation 3 in people with At Risk of Type 2 Diabetes Mellitus, run by Universiti Sultan Zainal Abidin at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- At Risk of Type 2 Diabetes Mellitus
- What is being tested?
- Formulation 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Oct 2021to 3 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Allergy or sensitivity to study products
- Pregnant, currently breastfeeding, or planning to become pregnant
- On dietary restrictions
- Smoker
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Food Preparation and Therapeutic Diet Lab, Faculty of Health Sciences, Universiti Sultan Zainal Abidin, Gong Badak Campus
Kuala Terengganu, Terengganu, 21300
About this study
Official title: Acute Effect of Melon Manis Terengganu 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.
Read the 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.
- Conditions
- At Risk of Type 2 Diabetes Mellitus
- Being tested
- Formulation 3, Control
- Keywords
- Melon Manis Terengganu peel, Glycemic response, Perceived satiety, Food intake, At risk of type 2 diabetes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formulation 3Other
Also called Formulated MMT peel powder
Respondents were consumed 36 g of Formulation 3 containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
ControlOther
Also called Glucose
Respondents were consumed 4.5 g of control containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast
| Study group | Role | What they receive |
|---|---|---|
| Formulation 3 | Active comparator | Formulated MMT peel powder (provide 5 g dietary fiber per day) Receives: Other: Formulation 3 |
| Control | Placebo comparator | Glucose Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (0 min), 30, 60, 90 and 120 minutes on Day 1 and Day 4 of both study visits
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Day 1 and day 4 of both study visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Oct 2021
- Primary completion3 Nov 2021
- Study completion3 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for At Risk of Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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).
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sultan Zainal Abidin
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Malaysia, Universiti Sains Malaysia
- Responsible party
- Principal investigator, Ong Ying Qian, Universiti Sultan Zainal Abidin
- Investigators
- Prof Dr Sakinah Harith, Principal investigator, Universiti Sultan Zainal AbidinDr Norshazila Shahidan, Principal investigator, Universiti Sultan Zainal AbidinProf Madya Dr Mohd Razif Shahril, Principal investigator, National University of MalaysiaProf Madya Dr Hermizi Hapidin, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298111
- Sponsor's protocol ID
- RCTOYQ
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2022
- Last updated
- 15 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24726414Tey 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.
PubMed 27956737Ong 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.
PubMed 35941609
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Melon Manis Terengganu Peel Powder on Glycemic Response, Satiety, and Food Intake in Adults at Risk for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05298111
- Acronym / sponsor ID
- RCTOYQ
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universiti Sultan Zainal AbidinUniversity, hospital or other
- Collaborators
- National University of Malaysia, Universiti Sains Malaysia
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Posted 15 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Formulation 3 | Active comparator | Other: Formulation 3Formulated MMT peel powder (provide 5 g dietary fiber per day) |
| Control | Placebo comparator | Other: ControlGlucose |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formulation 3Also: Formulated MMT peel powderRespondents were consumed 36 g of Formulation 3 containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast | Other | Formulation 3 |
| ControlAlso: GlucoseRespondents were consumed 4.5 g of control containing 4.5 g of available carbohydrate dissolved in 180 ml water with study breakfast | Other | Control |
Primary outcome
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.
3 secondary outcomes
Perceived Satiety (Area Under the Curve)
Time frame: Day 1 and 4 of both study visits
Food Intake
Time frame: Day 1 and 4 of both study visits
Calories Intake
Time frame: Day 1 and day 4 of both study visits
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24726414Teh 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.
- Background: PubMed 27956737Tey 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.
- Derived from this study: PubMed 35941609Ong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Dr Sakinah Harith principal investigator
Universiti Sultan Zainal Abidin
Dr Norshazila Shahidan principal investigator
Universiti Sultan Zainal Abidin
Prof Madya Dr Mohd Razif Shahril principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formulation 3 in people with At Risk of Type 2 Diabetes Mellitus, run by Universiti Sultan Zainal Abidin at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose Levels (time frame: Baseline (0 min), 30, 60, 90 and 120 minutes on Day 1 and Day 4 of both study visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05298111, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.