Healthy Volunteers Clinical Trial
Official title:
The Chemical Structure of a Lipid Determines Its Effect on Blood Lipid Profile and Fat Deposition
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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