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Effects of; FoodNCT06121817

Thermogenic Effect and Metabolic Responses of Durian

A study testing Food/meal intervention in people with Effects of; Food and Thermogenesis, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary aim of this study is to determine the effectiveness of durian on thermic effect of food (TEF), blood pressure, heart rate and postprandial glucose and lipid levels in young healthy men and women, compared to the ingestion of isocaloric banana. Read more about this study

Who is it for?
Ages 21 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Effects of; Food, Thermogenesis, Blood Pressure
What is being tested?
Food/meal intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteSingapore
Study dates
19 Jul 2023to 1 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

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 21 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • BMI with the range of 18-25 kg/m2
  • Aged between 21 and 40 year-old
  • Chinese origin
  • Non-diabetic, fasting blood glucose ≤ 5.6 mmol/L
  • Blood pressure below 140/90 mmHg
  • Pass the general health screening questionnaire
Show all 9Show fewer
  • Have a stable bodyweight (<5%) over the past 6 months
  • Have no medical history
  • Have ability to provide informed consent

Who cannot join

  • Subjects who are smoker or currently on nicotine therapy
  • Subjects who regularly consume alcohol (>1 unit per day)
  • Subjects who are currently receiving therapy (e.g. insulin) or any medication/treatment (including supplements) that may affect glucose and lipid metabolism, energy metabolism or body composition.
  • Subjects who are currently on steroids, protease inhibitors, or antipsychotic therapies
  • Subjects who recently had a major medical or surgical event or will have one during the study period
  • Subjects who have symptomatic Irritable Bowel Syndrome
Show all 17Show fewer
  • Subjects who have glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Subjects who have active Tuberculosis (TB) or currently receiving treatment for TB
  • Subjects who have chronic infection or is known to suffer from or has previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
  • Subjects who participated in drug trial within 3 months before the start of the study
  • Subjects who have allergy or intolerant to durian or/and banana
  • Subjects who are unwilling to consume durian or banana
  • Subjects who are hemophobia, trypanophobia, or claustrophobia
  • Subjects (females) who are pregnant (pregnancy test will be performed), lactating, or planning to become pregnant during the study period
  • Subjects who do not have adequate fluency in the English language
  • Subjects who are unable to understand the study procedures and to sign forms providing written informed consent to participate in the study
  • Subjects who are a member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Clinical Nutrition Research Centre (CNRC)

    Singapore, 117599

Other trials in Singapore

About this study

The primary aim of this study is to determine the effectiveness of durian on thermic effect of food (TEF), blood pressure, heart rate and postprandial glucose and lipid levels in young healthy men and women, compared to the ingestion of isocaloric banana.

Read the detailed description

Visit 1: Consenting and screening for study criteria. Visit 1 consists of consenting and screening session. Potential subjects will arrive at CNRC at 8h30 after 10-hour overnight fast (at least), only allowed access to water. A copy of written participant information sheet and informed consent form (ICF) will be given for them to read through carefully with needed time, and they may question for unclarity. Upon satisfaction, subjects must sign the ICF prior to the study procedures. After the consent, subjects will be screened for their eligibility with health screening questionnaire, and undergo anthropometric measurements (i.e. weight, height, waist circumference, and hip circumference). BMI will be calculated using formular weight divided by meter square (kg/m2). Blood pressure and heart rate readings will be taken. Body composition will be assessed using bioimpedance (BIA). Female subjects will be required to perform a β-HCG test using a urinary pregnancy test kit. Fasting glucose test will be performed through finger prick.

Visit 2 and 3: Intervention study (durian or banana will be assigned randomly) Visit 2 and visit 3 correspond to test session. Female subjects will be tested in the follicular phase of the menstrual cycle (the last menstrual cycle will be noted during screening and regular follow-up for the update). On each test day, subjects will arrive at CNRC at 8h30 after 10-hour overnight fast (at least), only water is allowed. They will undergo anthropometric measurements, and then instructed to lay comfortably on a bed in a suite (room temperature 22-24°C) for 45-minute of resting metabolic rate (RMR) measurement. Blood pressure, heart rate, fasting blood glucose, and fasting lipid will be performed before the meal test. At 9h30, subjects will be served 250g of durian or 417.6g of banana in a plate with 200 mL of water, and requested to consume the entire test meal within 10 min. Thermic effect of test meal will be performed after ingestion for 3 hours. Blood glucose fluctuation will be measured at 15 min, 30 min, 60 min, 90 min, 120 min, 180 min, and lipid fluctuation will be measured at 60 min, 120 min, and 180 min by finger prick. Blood pressure and heart rate readings will be taken at 30 min, 60 min, 120 min, 180 min.

Being tested
Food/meal intervention
Keywords
Thermic Effect of Food, Blood Glucose, Lipid test, Blood Pressure, Heart Rate, exotic fruits

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Food/meal interventionOther

    2 types of exotic fruits, durian and banana, are the study test meals. Both isocaloric test meals are performed at breakfast. All subjects are required to consume the entire meal within 10 minutes.

Study groups in NCT06121817
Study groupRoleWhat they receive
DurianExperimental250 g of durian aril (isocaloric)
Receives: Other: Food/meal intervention
BananaOther417.6 g of banana (isocaloric)
Receives: Other: Food/meal intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Thermic effect of food

    Measured using the Indirect calorimetry (canopy hood)

    Measured: 3 hours

  2. Blood Pressure

    Measured using an automated instrument (Omron HEM-907)

    Measured: 5 timepoints at 0 minute, 30 minutes, 60 minutes, 120 minutes, and 180 minutes

  3. Heart Rate

    Measured using an automated instrument (Omron HEM-907)

    Measured: 5 timepoints at 0 minute, 30 minutes, 60 minutes, 120 minutes, and 180 minutes

  4. Postprandial blood glucose levels

    Glucose levels will be measured using a portable glucose analyzer (Hemocue glucose 201 RT).

    Measured: 7 timepoints at 0 minute, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, and 180 minutes

  5. Postprandial lipid levels

    Triglycerides, Cholesterol, LDL, HDL measured using the Cobas b101 system

    Measured: 4 timepoints at 0 minute, 60 minutes, 120 minutes, and 180 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2023
  2. Study start19 Jul 2023
  3. Primary completion1 Mar 2024
  4. Study completion1 Mar 2024

Resources

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
All subjects will have both durian and banana interventions, with a wash-out period of at least 5 days between interventions.
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06121817
Sponsor's protocol ID
2023-052
Status last verified
May 2024
First submitted
2 Nov 2023
Last updated
16 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Access to and the key/password linking participant identifiable data to research data will be handed to a trusted third party (SIFBI HBRO) who is not part of the study team upon the end of data collection. All collected hardcopy data will be filed and stored in secure key-access drawers or in a key access room which will remain locked at all times. These keys are held by SIFBI HBRO and authorized staff at the centre and only study team members and authorized staff are allowed to draw the files. For electronic data, they will be stored in a secured computer that is password protected.

Publications

  • Ho LH, Bhat R. Exploring the potential nutraceutical values of durian (Durio zibethinus L.) - an exotic tropical fruit. Food Chem. 2015 Feb 1;168:80-9. doi: 10.1016/j.foodchem.2014.07.020. Epub 2014 Jul 11.

    PubMed 25172686

  • Terada Y, Hosono T, Seki T, Ariga T, Ito S, Narukawa M, Watanabe T. Sulphur-containing compounds of durian activate the thermogenesis-inducing receptors TRPA1 and TRPV1. Food Chem. 2014 Aug 15;157:213-20. doi: 10.1016/j.foodchem.2014.02.031. Epub 2014 Feb 15.

    PubMed 24679773

  • Zubairi, S.I., et al., Durian Locule (Endocarp) Water Immersion Drinking Effect to Reduce Heaty Sensation after Flesh Consumption: A Preliminary Study. Current Research in Nutrition and Food Science Journal, 2021. 9(3): p. 866-874.

  • Ling CY, Yeo MTY, Kang Y, Ng SM, Bi X, Henry CJ. Comparative Effects of Durian and Banana Consumption on Thermic Effect of Food and Metabolic Responses in Healthy Adults. J Am Nutr Assoc. 2025 May-Jun;44(4):283-291. doi: 10.1080/27697061.2024.2426563. Epub 2024 Nov 12.

    PubMed 39531559

Questions about this trial

What is this clinical trial studying?

A study testing Food/meal intervention in people with Effects of; Food and Thermogenesis, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.

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 9 inclusion and 17 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 16 May 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 Singapore. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Thermic effect of food (time frame: 3 hours). The study lists 5 primary outcomes in all. 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 NCT06121817, which also lists 4 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 16 May 2024.

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