Effect of Palm Olein Intake on Lipid Profile and Appetite Regulation

Not Applicable

Completed

• Conditions: Lipidaemia
• Interventions: Dietary Supplement: Palm olein; Dietary Supplement: Interesterified palm olein; Dietary Supplement: Soybean oil

• Registration Number: NCT02924896
• Lead Sponsor: Imperial College London

Brief Summary

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

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-28
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-05
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-10
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
randomization 1	Palm olein	Palm Olein, Interesterified Palm Olein, Soybean Oil
randomization 6	Soybean oil	Soybean Oil, Palm Olein, Interesterified Palm Olein
randomization 1	Soybean oil	Palm Olein, Interesterified Palm Olein, Soybean Oil
randomization 3	Interesterified palm olein	Interesterified Palm Olein, Palm Olein, Soybean Oil
randomization 4	Soybean oil	Interesterified Palm Olein, Soybean Oil, Palm Olein
randomization 3	Palm olein	Interesterified Palm Olein, Palm Olein, Soybean Oil
randomization 3	Soybean oil	Interesterified Palm Olein, Palm Olein, Soybean Oil
randomization 4	Palm olein	Interesterified Palm Olein, Soybean Oil, Palm Olein
randomization 4	Interesterified palm olein	Interesterified Palm Olein, Soybean Oil, Palm Olein
randomization 6	Palm olein	Soybean Oil, Palm Olein, Interesterified Palm Olein
randomization 1	Interesterified palm olein	Palm Olein, Interesterified Palm Olein, Soybean Oil
randomization 2	Palm olein	Palm Olein, Soybean Oil, Interesterified Palm Olein
randomization 2	Interesterified palm olein	Palm Olein, Soybean Oil, Interesterified Palm Olein
randomization 2	Soybean oil	Palm Olein, Soybean Oil, Interesterified Palm Olein
randomization 5	Soybean oil	Soybean Oil, Interesterified Palm Olein, Palm Olein
randomization 5	Palm olein	Soybean Oil, Interesterified Palm Olein, Palm Olein
randomization 5	Interesterified palm olein	Soybean Oil, Interesterified Palm Olein, Palm Olein
randomization 6	Interesterified palm olein	Soybean Oil, Palm Olein, Interesterified Palm Olein

Primary Outcome Measures

Name	Time	Method
change from baseline in appetite hormones	time (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480	blood samples will be collected at specific time points presented as minutes from consumption of mixed meal

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NIHR/Wellcome Trust Imperial Clinical Research Facility; 🇬🇧 London, United Kingdom