Clinical trial NCT05977244: Exploring the Effects of Varying Fat:Carbohydrate Diet Permutations on Gastric Emptying and Metabolic Status Using Human Postprandial Model
Official title: Exploring the Effects of Varying Fat:Carbohydrate Diet Permutations on Gastric Emptying and Metabolic Status Using Human Postprandial Model
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postprandial Lipemia
Postprandial Glycemia
Gastric Emptying
Keywords: meal composition
P/S ratio
macronutrient distribution
glycemic index
glycemia
lipemia
gut hormones
gastric emptying
Lead sponsor: Malaysia Palm Oil Board
Sponsor class: OTHER_GOV
Collaborators: name: Taylor's University
name: National University of Malaysia
First posted: 2023-08-04
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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?

Detailed description: The study's objectives will be tested via a randomized, crossover study with 16 diet rotations separated by minimum one week washout period. All recruited subjects will be randomly assigned into 2 groups of 7 each namely HGI and LGI with 9 diet rotations within each group. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Lipemia
timeFrame: 0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals
measure: Glycemia
timeFrame: 0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals
Secondary outcomes:
measure: Gastric emptying
timeFrame: 0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals
measure: Gut hormone
timeFrame: 0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Malaysian Palm Oil Board
state: Selangor
Study officials:
affiliation: Malaysia Palm Oil Board
name: Gowri Nagapan
role: PRINCIPAL_INVESTIGATOR
References: