Effect of Palm Olein Intake on Lipid Profile and Appetite Regulation

NCT ID: NCT02924896

Last Updated: 2025-06-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Aims: To investigate whether acute ingestions of palm oil will have an effect on appetite regulation

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Design: A randomized, single blind, cross over design including 4 single study visits separated by a week. Visit 1 is an acclimatization visit followed by visit 2,3, and 4 where different types of fat will be given.

Population: 12 healthy males and females aged between 18 and 60 years with body mass index (BMI) between 18.5- 29.9kg/m2 and normal fasting plasma glucose and no evidence of insulin resistance will be recruited. No-pre existing morbidity including cardiac, hepatic or renal disease, history of diabetes, hypertension or hyperlipidaemia.

Treatment: Acclimatization visit: At visit 1, all participants will be given a milkshake like drink containing fat, protein and carbohydrate. A cannula will be inserted for the duration of the study day but no blood will be taken. Studies show than during the first visit stress response can affect the metabolic response to the study drink resulting in inaccurate results.

Study visit 2,3,4: following the acclimatization visit, participants will attend 3 more study visits separated by a week to test the metabolic response to the following fats: palm olein, interesterified palm olein and soybean oil in random order. Participants will be asked to complete a visual analogue scale questionnaire about their appetite at each time point. Fasting and postprandial plasma glucose, insulin, appetite hormones and lipids will be measured.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lipidaemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Number of participants 12
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Palm Olein

Group Type OTHER

Palm olein

Intervention Type DIETARY_SUPPLEMENT

60g of palm olein will be given in a milkshake at breakfast

Interesterified palm olein

Intervention Type DIETARY_SUPPLEMENT

60g of interesterified palm olein will be given in a milkshake at breakfast

Soybean oil

Intervention Type DIETARY_SUPPLEMENT

60g of soybean oil will be given in a milkshake at breakfast

Arm 2

Soybean Oil

Group Type OTHER

Palm olein

Intervention Type DIETARY_SUPPLEMENT

60g of palm olein will be given in a milkshake at breakfast

Interesterified palm olein

Intervention Type DIETARY_SUPPLEMENT

60g of interesterified palm olein will be given in a milkshake at breakfast

Soybean oil

Intervention Type DIETARY_SUPPLEMENT

60g of soybean oil will be given in a milkshake at breakfast

Arm 3

Interesterified Palm Olein

Group Type OTHER

Palm olein

Intervention Type DIETARY_SUPPLEMENT

60g of palm olein will be given in a milkshake at breakfast

Interesterified palm olein

Intervention Type DIETARY_SUPPLEMENT

60g of interesterified palm olein will be given in a milkshake at breakfast

Soybean oil

Intervention Type DIETARY_SUPPLEMENT

60g of soybean oil will be given in a milkshake at breakfast

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Palm olein

60g of palm olein will be given in a milkshake at breakfast

Intervention Type DIETARY_SUPPLEMENT

Interesterified palm olein

60g of interesterified palm olein will be given in a milkshake at breakfast

Intervention Type DIETARY_SUPPLEMENT

Soybean oil

60g of soybean oil will be given in a milkshake at breakfast

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy and overweight male and female volunteers of all ethnicities (body mass index (BMI) of 18.5-29.9 kg/m2)
* Age between 18-60 years (inclusive)

Exclusion Criteria

* Abnormal liver function test (elevated alanine aminotransferase and aspartate transaminase)/ abnormal kidney function test (elevated plasma creatinine)
* History of type 2 diabetes mellitus, cancer, stomach ulcers, drug abuse or alcoholism, gastrointestinal disorders like Crohn's disease
* Smokers
* On lipid/blood pressure- lowering medication/supplements
* Blood pressure\>140/90 mm Hg
* Fasting total cholesterol \> 6.2 mmol/L
* Fasting triacylglyceride \> 2.0 mmol/L
* Subject must not be allergic to intervention
* Pregnancy and breastfeeding (pregnancy test will be undertaken at the screening visit)
* Subjects taking nutritional supplements or on any weight-loss programs
* Subjects who gained or lost ≥ 3kg weight in the past three months
* Subjects with history of hypo- and hyperthyroidism
* Subjects who are anaemic and those who donated blood within three months of the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Malaysia Palm Oil Board

OTHER_GOV

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gary Frost

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

NIHR/Wellcome Trust Imperial Clinical Research Facility

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

Access external resources that provide additional context or updates about the study.

http://imperial.crf.nihr.ac.uk/

Clinical Research Facility official web page

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

16/WA/0117

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.