Blood Pressure Clinical Trial
Official title:
Thermogenic Effect and Metabolic Responses of Durian
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 |
Verified date | May 2024 |
Source | Clinical Nutrition Research Centre, Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Singapore | Clinical Nutrition Research Centre (CNRC) | Singapore |
Lead Sponsor | Collaborator |
---|---|
Clinical Nutrition Research Centre, Singapore |
Singapore,
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.
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 |
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