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Postprandial LipemiaNCT05977244

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

A study testing FIJA, F1JB and F2JA in people with Postprandial Lipemia and Postprandial Glycemia, run by Malaysia Palm Oil Board at 3 sites in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 40 yearsHealthy volunteers can take part
What is being tested?
FIJA, F1JB and F2JA
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
3 sitesMalaysia
Study dates
21 May 2022to 24 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Malaysia3 sites
  • Malaysian Palm Oil Board

    Kajang, Selangor, 43000

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

    Kuala Lumpur, Kuala Lumpur, 56000

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

    Subang Jaya, Selangor, 47500

Other trials in Malaysia

About this study

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?
Read the 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.

Being tested
FIJA, F1JB, F2JA, F2JB, F3JA
Keywords
meal composition, P/S ratio, macronutrient distribution, glycemic index, glycemia, lipemia, gut hormones, gastric emptying
Medical subject headings
Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Study groups in NCT05977244
Study groupRoleWhat they receive
DIET FIJAExperimental1 portion of HGI (high glycemic index) fried rice, fried with oil A served together with 250 milliliter of plain water.
Receives: Other: FIJA
DIET F1JBExperimental1 portion of HGI (high glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water.
Receives: Other: F1JB
DIET F2JAExperimental1 portion of HGI (high glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water.
Receives: Other: F2JA
DIET F2JBExperimental1 portion of HGI (high glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water.
Receives: Other: F2JB
DIET F3JAExperimental1 portion of HGI (high glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water.
Receives: Other: F3JA
DIET F3JBExperimental1 portion of HGI (high glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water.
Receives: Other: F3JB
DIET F4JAExperimental1 portion of HGI (high glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water.
Receives: Other: F4JA
DIET F4JBExperimental1 portion of HGI (high glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water.
Receives: Other: F4JB
DIET F1PAExperimental1 portion of LGI (low glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water.
Receives: Other: F1PA
DIET F1PBExperimental1 portion of LGI (low glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water.
Receives: Other: F1PB
DIET F2PAExperimental1 portion of LGI (low glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water.
Receives: Other: F2PA
DIET F2PBExperimental1 portion of LGI (low glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water.
Receives: Other: F2PB
DIET F3PAExperimental1 portion of LGI (low glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water.
Receives: Other: F3PA
DIET F3PBExperimental1 portion of LGI (low glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water.
Receives: Other: F3PB
DIET F4PAExperimental1 portion of LGI (low glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water.
Receives: Other: F4PA
DIET F4PBExperimental1 portion of LGI (low glycemic index) fried rice, fried with oil B served together with 250 milliliter of plain water.
Receives: Other: F4PB
HGI PLAIN RICEPlacebo comparator1 portion of HGI (low glycemic index) plain rice served with 250 milliliters of plain water.
Receives: Other: HGI PLAIN RICE
LGI PLAIN RICEPlacebo comparator1 portion of HGI (low glycemic index) plain rice served with 250 milliliters of plain water.
Receives: Other: LGI PLAIN RICE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lipemia

    To determine the postprandial changes in triacylglyceride (TAG)

    Measured: 0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals

  2. Glycemia

    To determine the postprandial changes of glucose

    Measured: 0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals

Secondary outcomes (2)
  1. Gastric emptying

    To determine the postprandial changes in half emptying time

    Measured: 0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals

  2. Gut hormone

    To determine the postprandial changes of glucose-dependent insulinotropic polypeptide (GIP)

    Measured: 0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2023
  2. Study start21 May 2022
  3. Primary completion24 Dec 2024
  4. Study completion24 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05977244
Sponsor's protocol ID
PD233/18
Status last verified
May 2026
First submitted
17 Jul 2023
Last updated
26 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing FIJA, F1JB and F2JA in people with Postprandial Lipemia and Postprandial Glycemia, run by Malaysia Palm Oil Board at 3 sites in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lipemia (time frame: 0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.

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