Lipidaemia Clinical Trial
— APOOfficial title:
The Chemical Structure of a Lipid Determines Its Effect on Blood Lipid Profile and Appetite Regulation
| Verified date | October 2017 |
| Source | Imperial College London |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | April 2017 |
| Est. primary completion date | April 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | NIHR/Wellcome Trust Imperial Clinical Research Facility | London |
| Lead Sponsor | Collaborator |
|---|---|
| Imperial College London | Malaysia Palm Oil Board |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change from baseline in appetite hormones | 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 | |
| Secondary | change from baseline in lipids | 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 |