Exploring the Effects of Varying Fat:Carbohydrate Diet Permutations on Gastric Emptying and Metabolic Status Using Human Postprandial Model

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?

Study Overview

• Status: Completed
• Conditions: Gastric Emptying; Postprandial Lipemia; Postprandial Glycemia
• Intervention / Treatment: Other: FIJA; Other: F1JB; Other: F2JA; Other: F2JB; Other: F3JA; Other: F3JB; Other: F4JA; Other: F4JB; Other: F1PA; Other: F1PB; Other: F2PA; Other: F2PB; Other: F3PA; Other: F3PB; Other: F4PA; Other: F4PB; Other: HGI PLAIN RICE; Other: LGI PLAIN RICE

Detailed Description

The study's objectives will be tested via a crossover study with 18 diet rotations separated by minimum one week washout period. All recruited subjects will be assigned into, 9 HGI and 9 LGI diet rotations. The study design will be a cross-over trial with the same subjects undergoing all arms of the diet rotations. The subjects will be blinded to the test fats used for each rotation. Body weight measurements will be recorded before each postprandial challenge to minimise weight fluctuations between the test rotations.

Study procedures

1. Oral glucose tolerance test (OGTT) Sessions

   Prior and end of the test meal rotations, subjects will undergo oral glucose tolerance test (OGTT) with a glucose reference drink at 2 random sessions without MRI investigation at Taylor's University or Hospital Cancelor Tuanku Muhriz (HCTM), to get an average value for the plasma glucose and insulin standards for each subject. The glucose reference drink composition will be 50g of anhydrous glucose mixed with 250mL of room temperature water. Blood samples will be collected sequentially at 0, 15, 30, 60, 90,120 and 180 minutes.

2. Test meal sessions

During each postprandial test meal rotations, subjects will consume test meals followed by MRI scans at the MRI center at Hospital Cancelor Tuanku Muhriz(HCTM). For scheduled session, Subjects will be advised to refrain from strenuous physical activity, high calorie or fast-food, supplements and coffee intake for 24 hours preceding each postprandial event. Subjects will be at the clinical center at 7:30 and 8:30a.m, following a 12-hour overnight fast. Upon arrival at the centre, subjects will rest for 10min, followed by body weight, blood pressure and self-monitoring of blood glucose (SBMG) measurements. Subsequently, blood samples will be drawn for metabolic investigations as per study objectives. Sequential postprandial MRI scans before and after test meal intake at 0(fasting), 15, 30, 60, 90, 120, 180, 240 and 300 minutes.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 56000
      • Department of Medicine, Faculty of Medicine, Hospital Cancelor Tuanku Mukhriz, Universiti Kebangsaan Malaysia
  • Selangor
    • Kajang, Selangor, Malaysia, 43000
      • Malaysian Palm Oil Board
    • Subang Jaya, Selangor, Malaysia, 47500
      • School of Biosciences, Faculty of Health and Medical Sciences, Taylor's University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

1. Using pharmacotherapy that interferes with lipid and glucose metabolism or gastrointestinal transit (constipating drugs) or on oral contraceptives (women).
2. Underweight body mass index (BMI): < 18.5 kg/m2
3. With medical history of cardiovascular disease (CVD), Diabetes Mellitus, dyslipidemia and other chronic diseases,
4. acute or chronic gastrointestinal illness
5. If vulnerable to claustrophobia or anxiety
6. Regular alcohol usage
7. On low-calorie diets
8. Smoking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

18

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DIET FIJA; 1 portion of HGI (high glycemic index) fried rice, fried with oil A served together with 250 milliliter of plain water.	Other: FIJA; 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.
Experimental: DIET F1JB; 1 portion of HGI (high glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water.	Other: F1JB; 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.
Experimental: DIET F2JA; 1 portion of HGI (high glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water.	Other: F2JA; 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.
Experimental: DIET F2JB; 1 portion of HGI (high glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water.	Other: F2JB; A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
Experimental: DIET F3JA; 1 portion of HGI (high glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water.	Other: F3JA; A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
Experimental: DIET F3JB; 1 portion of HGI (high glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water.	Other: F3JB; A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after the consumption of test meal.
Experimental: DIET F4JA; 1 portion of HGI (high glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water.	Other: F4JA; A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
Experimental: DIET F4JB; 1 portion of HGI (high glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water.	Other: F4JB; A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
Experimental: DIET F1PA; 1 portion of LGI (low glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water.	Other: F1PA; A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
Experimental: DIET F1PB; 1 portion of LGI (low glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water.	Other: F1PB; A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
Experimental: DIET F2PA; 1 portion of LGI (low glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water.	Other: F2PA; A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
Experimental: DIET F2PB; 1 portion of LGI (low glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water.	Other: F2PB; A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
Experimental: DIET F3PA; 1 portion of LGI (low glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water.	Other: F3PA; A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
Experimental: DIET F3PB; 1 portion of LGI (low glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water.	Other: F3PB; A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
Experimental: DIET F4PA; 1 portion of LGI (low glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water.	Other: F4PA; A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
Experimental: DIET F4PB; 1 portion of LGI (low glycemic index) fried rice, fried with oil B served together with 250 milliliter of plain water.	Other: F4PB; A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
Placebo Comparator: HGI PLAIN RICE; 1 portion of HGI (low glycemic index) plain rice served with 250 milliliters of plain water.	Other: HGI PLAIN RICE; A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
Placebo Comparator: LGI PLAIN RICE; 1 portion of HGI (low glycemic index) plain rice served with 250 milliliters of plain water.	Other: LGI PLAIN RICE; A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric emptying	To determine the postprandial changes in half emptying time	0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals
Gut hormone	To determine the postprandial changes of glucose-dependent insulinotropic polypeptide (GIP)	0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals

Collaborators and Investigators

• Sponsor: Malaysia Palm Oil Board
• Collaborators: National University of Malaysia; Taylor's University
• Investigators: Principal Investigator: Gowri Nagapan, Malaysia Palm Oil Board; Study Chair: Tilakavati Dr Karupaiah, PhD, School of Biosciences, Faculty of Health and Medical Sciences, Taylor's University

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2022
• Primary Completion (Actual): December 24, 2024
• Study Completion (Actual): December 24, 2024

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: glycemic index; gastric emptying; glycemia; gut hormones; lipemia; meal composition; P/S ratio; macronutrient distribution
• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hyperlipidemias
• Other Study ID Numbers: PD233/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No