Effect of Palm Olein Intake on Lipid Profile and Appetite Regulation

Study Overview
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Brief Summary
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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.

Official Title
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The Chemical Structure of a Lipid Determines Its Effect on Blood Lipid Profile and Appetite Regulation

Conditions
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Lipidaemia

Intervention / Treatment
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* Dietary Supplement: Palm olein
* Dietary Supplement: Interesterified palm olein
* Dietary Supplement: Soybean oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: randomization 1<br>Palm Olein, Interesterified Palm Olein, Soybean Oil | Dietary Supplement: Palm olein<br>* 60g of palm olein will be given in a milkshake at breakfast<br>Dietary Supplement: Interesterified palm olein<br>* 60g of interesterified palm olein will be given in a milkshake at breakfast<br>Dietary Supplement: Soybean oil<br>* 60g of soybean oil will be given in a milkshake at breakfast<br>|
| Other: randomization 2<br>Palm Olein, Soybean Oil, Interesterified Palm Olein | Dietary Supplement: Palm olein<br>* 60g of palm olein will be given in a milkshake at breakfast<br>Dietary Supplement: Interesterified palm olein<br>* 60g of interesterified palm olein will be given in a milkshake at breakfast<br>Dietary Supplement: Soybean oil<br>* 60g of soybean oil will be given in a milkshake at breakfast<br>|
| Other: randomization 3<br>Interesterified Palm Olein, Palm Olein, Soybean Oil | Dietary Supplement: Palm olein<br>* 60g of palm olein will be given in a milkshake at breakfast<br>Dietary Supplement: Interesterified palm olein<br>* 60g of interesterified palm olein will be given in a milkshake at breakfast<br>Dietary Supplement: Soybean oil<br>* 60g of soybean oil will be given in a milkshake at breakfast<br>|
| Other: randomization 4<br>Interesterified Palm Olein, Soybean Oil, Palm Olein | Dietary Supplement: Palm olein<br>* 60g of palm olein will be given in a milkshake at breakfast<br>Dietary Supplement: Interesterified palm olein<br>* 60g of interesterified palm olein will be given in a milkshake at breakfast<br>Dietary Supplement: Soybean oil<br>* 60g of soybean oil will be given in a milkshake at breakfast<br>|
| Other: randomization 5<br>Soybean Oil, Interesterified Palm Olein, Palm Olein | Dietary Supplement: Palm olein<br>* 60g of palm olein will be given in a milkshake at breakfast<br>Dietary Supplement: Interesterified palm olein<br>* 60g of interesterified palm olein will be given in a milkshake at breakfast<br>Dietary Supplement: Soybean oil<br>* 60g of soybean oil will be given in a milkshake at breakfast<br>|
| Other: randomization 6<br>Soybean Oil, Palm Olein, Interesterified Palm Olein | Dietary Supplement: Palm olein<br>* 60g of palm olein will be given in a milkshake at breakfast<br>Dietary Supplement: Interesterified palm olein<br>* 60g of interesterified palm olein will be given in a milkshake at breakfast<br>Dietary Supplement: Soybean oil<br>* 60g of soybean oil will be given in a milkshake at breakfast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |