NCT02924896

Brief Summary

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

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 Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

September 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
8.2 years until next milestone

Results Posted

Study results publicly available

June 22, 2025

Completed
Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

September 28, 2016

Results QC Date

November 22, 2022

Last Update Submit

June 4, 2025

Conditions

Lipidaemia

Keywords

palm oilapetite regulation

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Appetite Hormones PYY

    blood samples will be collected at specific time points presented as minutes from consumption of mixed meal. time (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480.

    480 minutes

Secondary Outcomes (2)

  • Change From Baseline in Glucose,

    480 min

  • Change From Baseline in Appetite Hormones GLP_1

    ime (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480. Time Frame: 480 minutes

Study Arms (3)

Arm 1

OTHER

Palm Olein

Dietary Supplement: Palm oleinDietary Supplement: Interesterified palm oleinDietary Supplement: Soybean oil

Arm 2

OTHER

Soybean Oil

Dietary Supplement: Palm oleinDietary Supplement: Interesterified palm oleinDietary Supplement: Soybean oil

Arm 3

OTHER

Interesterified Palm Olein

Dietary Supplement: Palm oleinDietary Supplement: Interesterified palm oleinDietary Supplement: Soybean oil

Interventions

Palm oleinDIETARY_SUPPLEMENT

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

Arm 1Arm 2Arm 3
Interesterified palm oleinDIETARY_SUPPLEMENT

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

Arm 1Arm 2Arm 3
Soybean oilDIETARY_SUPPLEMENT

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

Arm 1Arm 2Arm 3

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIHR/Wellcome Trust Imperial Clinical Research Facility

London, W12 0HS, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Soybean Oil

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Prof Gary Frost
Organization
Imperial College London
g.frost@imperial.ac.uk
020 7589 5111

Study Officials

  • Gary Frost

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Number of participants 12
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2016

First Posted

October 5, 2016

Study Start

September 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

June 22, 2025

Results First Posted

June 22, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)