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Completed

NCT Number: NCT06121817

Thermogenic Effect and Metabolic Responses of Durian

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.

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Key information

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Nutrition Research Centre (CNRC)

Singapore, 117599

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Have a stable bodyweight (<5%) over the past 6 months
  • Have no medical history
  • Have ability to provide informed consent

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Food/meal intervention

Other

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.

Primary outcomes

  1. Thermic effect of food

    Time frame: 3 hours

    Measured using the Indirect calorimetry (canopy hood)

  2. Blood Pressure

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

    Measured using an automated instrument (Omron HEM-907)

  3. Heart Rate

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

    Measured using an automated instrument (Omron HEM-907)

  4. Postprandial blood glucose levels

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

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

  5. Postprandial lipid levels

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

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

Sponsors and collaborators

Lead sponsor

Singapore Institute of Food and Biotechnology Innovation

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2023
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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