NCT02897674

Brief Summary

Aims: To investigate whether diet with realistic doses on palm oil will have an effect on lipid profile and fat deposition in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable healthy-volunteers

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

February 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

October 17, 2019

Status Verified

October 1, 2019

Enrollment Period

3.5 years

First QC Date

August 17, 2016

Last Update Submit

October 15, 2019

Conditions

Healthy Volunteers

Keywords

palm oillipid profile

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in total cholesterol following the supplementation

    fasting measure in week 3, 6, 10, 14

Secondary Outcomes (3)

  • Change from baseline in body composition

    Fasting measure in week 3 and week 14

  • Change from baseline in lipoproteins

    time=0 in week 3, 6, 10, 14

  • Postprandial change in appetite hormones

    time=-15, -5,15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480 in week 3 and week 14

Study Arms (2)

Normal weight

EXPERIMENTAL

Participants will BMI 18.5-24.9 kg/m2 will consume 20% of their calories from one of the three dietary fats Intervention: palm olei Intervention: interesterified palm olein Intervention: soybean oil

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

Overweight

EXPERIMENTAL

Participants will BMI 25-29.9 kg/m2 will consume 20% of their calories from one of the three dietary fats Intervention: palm olei Intervention: interesterified palm olein Intervention: soybean oil

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

Interventions

Palm oleinDIETARY_SUPPLEMENT

two thirds of the 30% fat calories will come from palm olein

Normal weightOverweight
Interesterified palm oleinDIETARY_SUPPLEMENT

two thirds of the 30% fat calories will come from interesterified palm olein

Normal weightOverweight
soybean oilDIETARY_SUPPLEMENT

two thirds of the 30% fat calories will come from soybean oil

Normal weightOverweight

Eligibility Criteria

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

You may qualify if:

  • Phase I: 30 healthy volunteers (male and female), of all ethnicities, aged 18-60 years, with a body mass index (BMI) of 18.5-25kg/m2.
  • Phase II: 30 healthy volunteers (male and female), of all ethnicities, aged 18-60 years, with a BMI of 25-29.9kg/m2.

You may not qualify if:

  • Following a high fat diet (more than 40% calories coming from fat)
  • 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
  • Candidates who are going abroad during the planned schedule for the dietary intervention
  • 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
  • Female subjects were not on oral contraceptives.
  • Subjects with history of hypo- and hyperthyroidism
  • +2 more criteria

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

Interventions

Soybean Oil

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Gary Frost

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

September 13, 2016

Study Start

February 1, 2016

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

October 17, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)