- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07541300
The Effects of Palm Olein and Palm Kernel Oil Diets on Gut Hormones and Appetite in Healthy Adults
The goal of this clinical trial is to investigate the postprandial effect of palm olein- and palm kernel oil- diets compared to PUFA-rich diet (sunflower oil in this study) on gut hormones response and appetite in healthy adults. The main questions it aims to answer are:
• Do palm olein- and palm kernel oil-diets postulate to improve satiety and lower appetite compared to PUFA rich diet (sunflower oil) in healthy adults? Researchers will compare diets prepared with palm olain or palm kernel oil to a diet prepared with sunflower oil to see the effects of these three diets on gut hormones and satiety score.
Participants will:
- Attend a health screening session for subjects selection according to inclusion and exclusion criteria.
- Visit the study center three times with 2 weeks apart.
- Provide blood samples and fill up questionnaires at different time point within 4 hours.
- Receive a ad libitum meal after 4 hours intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Selangor
-
Kajang, Selangor, Malaysia, 43300
- Malaysian Palm Oil Board
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 20 to 45 years.
- BMI 20 to 27.5 kg/m2.
- Blood pressure with 90 to 130 mmHg for systolic and 60 to 80 mmHg for diastolic measurements.
- Fasting blood glucose of 3.9 to 5.5 mmol/L.
- Fasting total cholesterol < 6.0 mmol/L.
- Fasting triglycerides < 2.3 mmol/L.
- Not using any form of nicotine and alcohol.
Exclusion Criteria:
- Diagnosed any form of heart disease, hypertension, diabetes mellitus, and metabolic syndrome with or without medication.
- Consuming any long term prescribed medications or supplements, including hormonal contraceptive pills.
- Having moderate anaemia with haemoglobin <110 g/l for men and <100 g/l for women.
- Having blood clotting problem
- Having difficulty in cannulation (small, thin or hard-to-find veins)
- Women who are pregnant or lactating.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: P
PO-PKO-SFO
|
high-fat muffin prepared with 50g palm olein
high-fat muffin prepared with 50g palm kernel oil
high-fat muffin prepared with 50g sunflower oil
|
|
Experimental: Q
PO-SFO-PKO
|
high-fat muffin prepared with 50g palm olein
high-fat muffin prepared with 50g palm kernel oil
high-fat muffin prepared with 50g sunflower oil
|
|
Experimental: R
PKO-PO-SFO
|
high-fat muffin prepared with 50g palm olein
high-fat muffin prepared with 50g palm kernel oil
high-fat muffin prepared with 50g sunflower oil
|
|
Experimental: S
PKO-SFO-PO
|
high-fat muffin prepared with 50g palm olein
high-fat muffin prepared with 50g palm kernel oil
high-fat muffin prepared with 50g sunflower oil
|
|
Experimental: T
SFO-PO-PKO
|
high-fat muffin prepared with 50g palm olein
high-fat muffin prepared with 50g palm kernel oil
high-fat muffin prepared with 50g sunflower oil
|
|
Experimental: U
SFO-PKO-PO
|
high-fat muffin prepared with 50g palm olein
high-fat muffin prepared with 50g palm kernel oil
high-fat muffin prepared with 50g sunflower oil
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glucose-dependent Insulinotropic Polypeptide (GIP)
Time Frame: postprandial from baseline (0 min) to 4 hours
|
GIP analysed using ELISA kits using plasma sample.
|
postprandial from baseline (0 min) to 4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glucagon-like Peptide 1 (GLP-1)
Time Frame: Postprandial from baseline (0 min) to 4 hours
|
GLP-1 is analysed with ELISA kit using plasma.
|
Postprandial from baseline (0 min) to 4 hours
|
|
Peptide YY (PYY)
Time Frame: Postprandial from baseline (0 min) to 4 hours
|
PYY is analysed with ELISA kit using plasma sample.
|
Postprandial from baseline (0 min) to 4 hours
|
|
Ghrelin
Time Frame: Postprandial from baseline (0 min) to 4 hours
|
Ghreli is analysed using ELISA kits using plasma sample.
|
Postprandial from baseline (0 min) to 4 hours
|
|
HOMA IR
Time Frame: Postprandial from baseline (0 min) up to 2 hours.
|
HOMA IR will be calculated using glucose, insulin and c-peptide levels measured.
|
Postprandial from baseline (0 min) up to 2 hours.
|
|
Cholecytokinin, CCK
Time Frame: Postprandial from baseline (0 min) to 4 hours.
|
CCK is analysed with ELISA kit using plasma.
|
Postprandial from baseline (0 min) to 4 hours.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FN2-13/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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