Thermogenic Effect and Metabolic Responses of Durian

NCT06121817 | Completed

• 1 other identifier: 2023-052
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Effects of; Food; Thermogenesis; Blood Pressure; Heart Rate

Keywords

Thermic Effect of Food; Blood Glucose; Lipid test; Blood Pressure; Heart Rate; exotic fruits

Outcome Measures

Primary Outcomes (5)

• Thermic effect of food

  Measured using the Indirect calorimetry (canopy hood)

  3 hours

• Blood Pressure

  Measured using an automated instrument (Omron HEM-907)

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

• Heart Rate

  Measured using an automated instrument (Omron HEM-907)

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

• 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

• 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

Study Arms (2)

Durian

EXPERIMENTAL

250 g of durian aril (isocaloric)

Other: Food/meal intervention

Banana

OTHER

417.6 g of banana (isocaloric)

Other: Food/meal intervention

Interventions

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.

Banana; Durian

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: 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).
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead

Study Sites (1)

Clinical Nutrition Research Centre (CNRC)

Singapore, 117599, Singapore

Location

Related 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.

  PMID: 25172686 BACKGROUND

• 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.

  PMID: 24679773 BACKGROUND

• 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.

  BACKGROUND

Study Officials

• XinYan Bi, PhD

  Senior Scientist II

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: All subjects will have both durian and banana interventions, with a wash-out period of at least 5 days between interventions.

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 8, 2023
• Study Start: July 19, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)