NCT05977244

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2024

Completed
Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

2.6 years

First QC Date

July 17, 2023

Last Update Submit

May 21, 2026

Conditions

Postprandial LipemiaPostprandial GlycemiaGastric Emptying

Keywords

meal compositionP/S ratiomacronutrient distributionglycemic indexglycemialipemiagut hormonesgastric emptying

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 (18)

DIET FIJA

EXPERIMENTAL

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

Other: FIJA

DIET F1JB

EXPERIMENTAL

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

Other: F1JB

DIET F2JA

EXPERIMENTAL

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

Other: F2JA

DIET F2JB

EXPERIMENTAL

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

Other: F2JB

DIET F3JA

EXPERIMENTAL

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

Other: F3JA

DIET F3JB

EXPERIMENTAL

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

Other: F3JB

DIET F4JA

EXPERIMENTAL

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

Other: F4JA

DIET F4JB

EXPERIMENTAL

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

Other: F4JB

DIET F1PA

EXPERIMENTAL

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

Other: F1PA

DIET F1PB

EXPERIMENTAL

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

Other: F1PB

DIET F2PA

EXPERIMENTAL

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

Other: F2PA

DIET F2PB

EXPERIMENTAL

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

Other: F2PB

DIET F3PA

EXPERIMENTAL

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

Other: F3PA

DIET F3PB

EXPERIMENTAL

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

Other: F3PB

DIET F4PA

EXPERIMENTAL

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

Other: F4PA

DIET F4PB

EXPERIMENTAL

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

Other: F4PB

HGI PLAIN RICE

PLACEBO COMPARATOR

1 portion of HGI (low glycemic index) plain rice served with 250 milliliters of plain water.

Other: HGI PLAIN RICE

LGI PLAIN RICE

PLACEBO COMPARATOR

1 portion of HGI (low glycemic index) plain rice served with 250 milliliters of plain water.

Other: LGI PLAIN RICE

Interventions

FIJAOTHER

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.

DIET FIJA
F1JBOTHER

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.

DIET F1JB
F2JAOTHER

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.

DIET F2JA
F2JBOTHER

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.

DIET F2JB
F3JAOTHER

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.

DIET F3JA
F3JBOTHER

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.

DIET F3JB
F4JAOTHER

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.

DIET F4JA
F4JBOTHER

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.

DIET F4JB
F1PAOTHER

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.

DIET F1PA
F1PBOTHER

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.

DIET F1PB
F2PAOTHER

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.

DIET F2PA
F2PBOTHER

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.

DIET F2PB
F3PAOTHER

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.

DIET F3PA
F3PBOTHER

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.

DIET F3PB
F4PAOTHER

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.

DIET F4PA
F4PBOTHER

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.

DIET F4PB
HGI PLAIN RICEOTHER

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.

HGI PLAIN RICE
LGI PLAIN RICEOTHER

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.

LGI PLAIN RICE

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (3)

Department of Medicine, Faculty of Medicine, Hospital Cancelor Tuanku Mukhriz, Universiti Kebangsaan Malaysia

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

Malaysian Palm Oil Board

Kajang, Selangor, 43000, Malaysia

Location

School of Biosciences, Faculty of Health and Medical Sciences, Taylor's University

Subang Jaya, Selangor, 47500, Malaysia

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Gowri Nagapan

    Malaysia Palm Oil Board

    PRINCIPAL INVESTIGATOR

  • Tilakavati Dr Karupaiah, PhD

    School of Biosciences, Faculty of Health and Medical Sciences, Taylor's University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
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

December 24, 2024

Study Completion

December 24, 2024

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

MY(3)