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

Primary Purpose

Postprandial Lipemia, Postprandial Glycemia, Gastric Emptying

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
HGI+palm olein
LGI+palm olein
HGI+soy bean oil
LGI+soy bean oil
Sponsored by
Malaysia Palm Oil Board
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Postprandial Lipemia focused on measuring meal composition, P/S ratio, macronutrient distribution, glycemic index, glycemia, lipemia, gut hormones, gastric emptying

Eligibility Criteria

21 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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: 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

Sites / Locations

  • Malaysian Palm Oil BoardRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

HGI+palm olein

HGI+soy bean oil

LGI+palm olein

LGI+soy bean oil

Arm Description

1 portion of HGI(high glycemic index) fried rice, fried with palm olein will be served together with 250 milliliter of plain water.

1 portion of HGI (high glycemic index) fried rice, fried with soybean oil will be served together with 250 milliliter of plain water.

1 portion of LGI (low glycemic index) fried rice, fried with palm olein will be served together with 250 milliliter of plain water.

1 portion of LGI (low glycemic index) fried rice, fried with soybean oil will be served together with 250 milliliter of plain water.

Outcomes

Primary Outcome Measures

Lipemia
To determine the postprandial changes in triacylglyceride (TAG)
Glycemia
To determine the postprandial changes of glucose

Secondary Outcome Measures

Gastric emptying
To determine the postprandial changes in half emptying time
Gut hormone
To determine the postprandial changes of glucose-dependent insulinotropic polypeptide (GIP)

Full Information

First Posted
July 17, 2023
Last Updated
July 28, 2023
Sponsor
Malaysia Palm Oil Board
Collaborators
Taylor's University, National University of Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05977244
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Malaysia Palm Oil Board
Collaborators
Taylor's University, National University of Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: How does meal composition with different polyunsaturated/saturated (P/S) ratio, glycemic index and macronutrient quantity affect lipemia and glycemia? 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 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Lipemia, Postprandial Glycemia, Gastric Emptying
Keywords
meal composition, P/S ratio, macronutrient distribution, glycemic index, glycemia, lipemia, gut hormones, gastric emptying

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HGI+palm olein
Arm Type
Experimental
Arm Description
1 portion of HGI(high glycemic index) fried rice, fried with palm olein will be served together with 250 milliliter of plain water.
Arm Title
HGI+soy bean oil
Arm Type
Experimental
Arm Description
1 portion of HGI (high glycemic index) fried rice, fried with soybean oil will be served together with 250 milliliter of plain water.
Arm Title
LGI+palm olein
Arm Type
Experimental
Arm Description
1 portion of LGI (low glycemic index) fried rice, fried with palm olein will be served together with 250 milliliter of plain water.
Arm Title
LGI+soy bean oil
Arm Type
Experimental
Arm Description
1 portion of LGI (low glycemic index) fried rice, fried with soybean oil will be served together with 250 milliliter of plain water.
Intervention Type
Other
Intervention Name(s)
HGI+palm olein
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
LGI+palm olein
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
HGI+soy bean oil
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
LGI+soy bean oil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lipemia
Description
To determine the postprandial changes in triacylglyceride (TAG)
Time Frame
0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals
Title
Glycemia
Description
To determine the postprandial changes of glucose
Time Frame
0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals
Secondary Outcome Measure Information:
Title
Gastric emptying
Description
To determine the postprandial changes in half emptying time
Time Frame
0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals
Title
Gut hormone
Description
To determine the postprandial changes of glucose-dependent insulinotropic polypeptide (GIP)
Time Frame
0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gowri Ms Nagapan, MSc
Phone
0126673592
Email
gowri@mpob.gov.my
First Name & Middle Initial & Last Name or Official Title & Degree
Teng Dr Kim Tiu, PhD
Email
kimtiu@mpob.gov.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gowri Nagapan
Organizational Affiliation
Malaysia Palm Oil Board
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malaysian Palm Oil Board
City
Kajang
State/Province
Selangor
ZIP/Postal Code
43000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gowri Nagapan, MSc
Phone
0126673592
Email
gowri@mpob.gov.my

12. IPD Sharing Statement

Plan to Share IPD
No

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

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