Effect of Palm Olein Intake on Lipid Profile and Fat Deposition
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Aims: To investigate whether diet with realistic doses on palm oil will have an effect on
      lipid profile and fat deposition in healthy volunteers.
    

Detailed description: 
      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.
    

Intervention name(s): Palm olein; Interesterified palm olein; soybean oil
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): two thirds of the 30% fat calories will come from palm olein; two thirds of the 30% fat calories will come from interesterified palm olein; two thirds of the 30% fat calories will come from soybean oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: palm oil; lipid profile