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| Name | Class |
|---|---|
| Malaysia Palm Oil Board | OTHER_GOV |
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Aims: To investigate whether diet with realistic doses on palm oil will have an effect on lipid profile and fat deposition in healthy volunteers.
Design: Randomized, parallel design over 14 weeks including a 2 week standardization period and 12 week supplementation. In the standardization period all participants will incorporate palm oil into their diet which will make up 20% of their calories providing a baseline measure. In the supplementation period of 12 weeks, each volunteer will be randomized into one of the three fats: palm olein, interesterified palm olein or soybean oil, consuming 20% of their calories from these fast and remaining 10% fat calories from fats naturally occurring in foods like meat and nuts. Otherwise participants will keep the rest of their diet habitual.
Population: 60 healthy males and females aged between 18 and 60 years, of which 30 participants with a BMI between 18.5-24.9kg/m2 and 30 participants with a BMI between 25-29.9kg/m2 and 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 hyperlipidemia.
Treatment: Pre-intervention: Participants will be asked to record habitual dietary intake by completion of a 4-day food diary and be asked to wear an accelerometer armband to assess physical activity at the beginning and at the end of supplementation period.
2 weeks standardization period: All participants will be asked to replace added fat in their diet with palm olein providing two thirds of 30% fat calories.
At the end of the standardization period, which will be the first day of a 12 week dietary intervention, as well as at the end of 12 week supplementation, participants will attend the clinical research facility for a study visit. Weight, height and waist circumference will be taken; total and regional body composition will be measured by MRI. Fasting and post prandial plasma glucose, insulin, appetite hormones and lipids will be measured. Participants will be asked to come in for follow-up visits at week 6 and 10 for a single blood samples and weight check.
12 week supplementation period: participants will be randomized into one of the three supplementation groups: palm olein, interesterified palm olein or soybean oil. Participants will be asked to consume two thirds of their 30%fat calories from one of the oils while incorporating it into their normal diet in cooking and baking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palm olein | Dietary Supplement | two thirds of the 30% fat calories will come from palm olein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in total cholesterol following the supplementation | fasting measure in week 3, 6, 10, 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in body composition | total and regional body composition assessed by MRI | Fasting measure in week 3 and week 14 |
| Change from baseline in lipoproteins | time=0 in week 3, 6, 10, 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Frost | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIHR/Wellcome Trust Imperial Clinical Research Facility | London | W12 0HS | United Kingdom |
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| Label | URL |
|---|---|
| Clinical Research Facility | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 22, 2022 | |
| Reset | Sep 29, 2023 | |
| Release | Mar 22, 2024 | |
| Reset | Aug 16, 2024 | |
| Release | Mar 31, 2025 | |
| Reset | Apr 16, 2025 | |
| Release | Jun 4, 2025 | |
| Reset | Jun 20, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 22, 2022 | Sep 29, 2023 | |||
| Mar 22, 2024 |
| ID | Term |
|---|---|
| D013024 | Soybean Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Interesterified palm olein | Dietary Supplement | two thirds of the 30% fat calories will come from interesterified palm olein |
|
| soybean oil | Dietary Supplement | two thirds of the 30% fat calories will come from soybean oil |
|
| 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 |
| Aug 16, 2024 |
| Mar 31, 2025 | Apr 16, 2025 |
| Jun 4, 2025 | Jun 20, 2025 |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |