Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06121817
Other study ID # 2023-052
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 19, 2023
Est. completion date March 1, 2024

Study information

Verified date May 2024
Source Clinical Nutrition Research Centre, Singapore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date March 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Food/meal intervention
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.

Locations

Country Name City State
Singapore Clinical Nutrition Research Centre (CNRC) Singapore

Sponsors (1)

Lead Sponsor Collaborator
Clinical Nutrition Research Centre, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

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. — View Citation

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. — View Citation

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.

Outcome

Type Measure Description Time frame Safety issue
Primary Thermic effect of food Measured using the Indirect calorimetry (canopy hood) 3 hours
Primary Blood Pressure Measured using an automated instrument (Omron HEM-907) 5 timepoints at 0 minute, 30 minutes, 60 minutes, 120 minutes, and 180 minutes
Primary Heart Rate Measured using an automated instrument (Omron HEM-907) 5 timepoints at 0 minute, 30 minutes, 60 minutes, 120 minutes, and 180 minutes
Primary Postprandial blood glucose levels Glucose levels will be measured using a portable glucose analyzer (Hemocue glucose 201 RT). 7 timepoints at 0 minute, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, and 180 minutes
Primary Postprandial lipid levels Triglycerides, Cholesterol, LDL, HDL measured using the Cobas b101 system 4 timepoints at 0 minute, 60 minutes, 120 minutes, and 180 minutes
See also
  Status Clinical Trial Phase
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT05997303 - Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT03918486 - Caretaker vs. Routine Blood Pressure Sphygmomanometer
Completed NCT03410342 - The Effects of Types of Fruits and Vegetables on Vascular Function N/A
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT04087070 - Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
Completed NCT03294928 - Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers N/A
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03997461 - Comparison of Arterial Tonometry Sensor With Standard Oscillometric Blood Pressure Monitoring Device N/A
Completed NCT03290716 - Diet, ExerCIse and carDiovascular hEalth (DECIDE) - Salt Reduction Strategies for the Elderly in Nursing Homes in China N/A
Recruiting NCT06460233 - Blood Pressure Changes After Bariatric Surgery
Recruiting NCT05196048 - Blood Pressure Sensor of Watch-type Device With ECG Technology
Terminated NCT03325933 - Resistance Training and Cardiometabolic Health N/A
Not yet recruiting NCT06405880 - Pharmacist Case Finding and Intervention for Vascular Prevention Trial N/A
Completed NCT02924454 - Effects of Lipid Emulsion on the Pharmacokinetic and Pharmacodynamic Properties of Metoprolol. Phase 4
Completed NCT02451059 - Reducing Socioeconomic Disparities in Health at Pediatric Visits N/A
Active, not recruiting NCT02670967 - Effects of Soluble Fiber on Blood Pressure: A Meta-analysis of Randomly-controlled Trials N/A
Completed NCT02239744 - Intervention Study on the Health Impact of Air Filters in Chinese Adults N/A
Completed NCT02271633 - Nitrate Supplementation; Source Phase 4