Thermogenic Effect and Metabolic Responses of Durian

Sponsor

Clinical Nutrition Research Centre, Singapore (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06121817

Collaborator

(none)

Enrollment

Location

Arms

5.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Effects of; Food Thermogenesis Blood Pressure Heart Rate	Other: Food/meal intervention	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Thermogenic Effect and Metabolic Responses of Durian

Actual Study Start Date :

Jul 19, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Durian 250 g of durian aril (isocaloric)	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.
Other: Banana 417.6 g of banana (isocaloric)	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.

Arm

Intervention/Treatment

Experimental: Durian

250 g of durian aril (isocaloric)

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.

Other: Banana

417.6 g of banana (isocaloric)

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.

Outcome Measures

Primary Outcome Measures

Thermic effect of food [3 hours]
Measured using the Indirect calorimetry (canopy hood)
Blood Pressure [5 timepoints at 0 minute, 30 minutes, 60 minutes, 120 minutes, and 180 minutes]
Measured using an automated instrument (Omron HEM-907)
Heart Rate [5 timepoints at 0 minute, 30 minutes, 60 minutes, 120 minutes, and 180 minutes]
Measured using an automated instrument (Omron HEM-907)
Postprandial blood glucose levels [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).
Postprandial lipid levels [4 timepoints at 0 minute, 60 minutes, 120 minutes, and 180 minutes]
Triglycerides, Cholesterol, LDL, HDL measured using the Cobas b101 system

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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