Exploring the Effects of Varying Fat:Carbohydrate Diet Permutations on Gastric Emptying and Metabolic Status Using Human Postprandial Model
1 other identifier
interventional
14
1 country
1
Brief Summary
The aim of this clinical trial is to investigate the effects of the meals moderated by fat and carbohydrate (CHO) quality along with varying macronutrient distribution (CHO: fat) on gut physiology and metabolic outcomes using the human postprandial model with healthy subjects. The main question\[s\] it aims to answer are:
- 1.How does meal composition with different polyunsaturated/saturated (P/S) ratio, glycemic index and macronutrient quantity affect lipemia and glycemia?
- 2.How does meal composition with different P/S ratio, Glycemic index and macronutrient quantity affect gastric emptying?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2022
CompletedFirst Submitted
Initial submission to the registry
July 17, 2023
CompletedFirst Posted
Study publicly available on registry
August 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedAugust 4, 2023
July 1, 2023
1.8 years
July 17, 2023
July 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Lipemia
To determine the postprandial changes in triacylglyceride (TAG)
0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals
Glycemia
To determine the postprandial changes of glucose
0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals
Secondary Outcomes (2)
Gastric emptying
0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals
Gut hormone
0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals
Study Arms (4)
HGI+palm olein
EXPERIMENTAL1 portion of HGI(high glycemic index) fried rice, fried with palm olein will be served together with 250 milliliter of plain water.
HGI+soy bean oil
EXPERIMENTAL1 portion of HGI (high glycemic index) fried rice, fried with soybean oil will be served together with 250 milliliter of plain water.
LGI+palm olein
EXPERIMENTAL1 portion of LGI (low glycemic index) fried rice, fried with palm olein will be served together with 250 milliliter of plain water.
LGI+soy bean oil
EXPERIMENTAL1 portion of LGI (low glycemic index) fried rice, fried with soybean oil will be served together with 250 milliliter of plain water.
Interventions
A 5-hour postprandial feeding intervention with 1-weeks washout in between. Blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
A 5-hour postprandial feeding intervention with 1-weeks washout in between. Blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
A 5-hour postprandial feeding intervention with 1-weeks washout in between. Blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
A 5-hour postprandial feeding intervention with 1-weeks washout in between. Blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
Eligibility Criteria
You may qualify if:
- Healthy subjects, (n=12-14) without history of chronic disease(s) with body mass index (BMI) between 18.5-25.0 kg/m2 and normal fasting blood glucose status \[\<5.4 mmol/L\] will be enrolled into the study.
You may not qualify if:
- Using pharmacotherapy that interferes with lipid and glucose metabolism or gastrointestinal transit (constipating drugs) or on oral contraceptives (women).
- Underweight body mass index (BMI): \< 18.5 kg/m2
- With medical history of cardiovascular disease (CVD), Diabetes Mellitus, dyslipidemia and other chronic diseases,
- acute or chronic gastrointestinal illness
- If vulnerable to claustrophobia or anxiety
- Regular alcohol usage
- On low-calorie diets
- Smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Malaysia Palm Oil Boardlead
- Taylor's Universitycollaborator
- National University of Malaysiacollaborator
Study Sites (1)
Malaysian Palm Oil Board
Kajang, Selangor, 43000, Malaysia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gowri Nagapan
Malaysia Palm Oil Board
Central Study Contacts
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
Study Record Dates
First Submitted
July 17, 2023
First Posted
August 4, 2023
Study Start
May 21, 2022
Primary Completion
March 1, 2024
Study Completion
March 1, 2024
Last Updated
August 4, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share