Thermogenic Effect and Metabolic Responses of Durian

Blood Pressure Clinical Trial

Official title:

Thermogenic Effect and Metabolic Responses of Durian

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06121817
• Other study ID #: 2023-052
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Blood Pressure
• Heart Rate
• Thermogenesis

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