Clinical trial NCT02924896: Effect of Palm Olein Intake on Lipid Profile and Appetite Regulation
Official title: The Chemical Structure of a Lipid Determines Its Effect on Blood Lipid Profile and Appetite Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipidaemia
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Malaysia Palm Oil Board
First posted: 2016-10-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: change from baseline in appetite hormones
timeFrame: time (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480
Secondary outcomes:
measure: change from baseline in lipids
timeFrame: time (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: NIHR/Wellcome Trust Imperial Clinical Research Facility
Study officials:
affiliation: Imperial College London
name: Gary Frost
role: PRINCIPAL_INVESTIGATOR
References: