Clinical trial NCT06121817: Thermogenic Effect and Metabolic Responses of Durian
Official title: Thermogenic Effect and Metabolic Responses of Durian
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of; Food
Thermogenesis
Blood Pressure
Heart Rate
Keywords: Thermic Effect of Food
Blood Glucose
Lipid test
Blood Pressure
Heart Rate
exotic fruits
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
First posted: 2023-11-08
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All subjects will have both durian and banana interventions, with a wash-out period of at least 5 days between interventions.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Thermic effect of food
timeFrame: 3 hours
measure: Blood Pressure
timeFrame: 5 timepoints at 0 minute, 30 minutes, 60 minutes, 120 minutes, and 180 minutes
measure: Heart Rate
timeFrame: 5 timepoints at 0 minute, 30 minutes, 60 minutes, 120 minutes, and 180 minutes
measure: Postprandial blood glucose levels
timeFrame: 7 timepoints at 0 minute, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, and 180 minutes
measure: Postprandial lipid levels
timeFrame: 4 timepoints at 0 minute, 60 minutes, 120 minutes, and 180 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Clinical Nutrition Research Centre (CNRC)
Study officials:
affiliation: Senior Scientist II
name: XinYan Bi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.