Saturated Fatty Acids and HDL Metabolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-14

Study Completion Date

2017-07-01

Brief Summary

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The purpose of this study is to determine whether palmitic acid (C16:0) and stearic acid (C18:0) have different effects on HDL metabolism during the fasted state.

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Detailed Description

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Study design:

Double blind, randomized, cross-over study with two different diets: one diet will be high in palmitic acid (C16:0) and the other diet will be high in stearic acid (C18:0). Subjects will receive both diets for 4 weeks with a wash-out period of 4-6 weeks in between. Contrast in the intakes of palmitic acid and stearic acid is 6% of energy. A postprandial test will be carried out at the end of each dietary period.

Study population:

Accounting for a dropout rate of 20%, 40 healthy men and postmenopausal women, aged between 45 and 70 year, having a BMI (body mass index) between ≥ 18.0 and ≤ 30.0 kg/m2 will be recruited.

Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Palmitic acid

Diet rich in palmitic acid

Group Type EXPERIMENTAL

Palmitic acid

Intervention Type DIETARY_SUPPLEMENT

Experimental products are enriched with C16:0

Stearic acid

Diet rich in stearic acid

Group Type EXPERIMENTAL

Stearic acid

Intervention Type DIETARY_SUPPLEMENT

Experimental products are enriched with C18:0

Interventions

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Palmitic acid

Experimental products are enriched with C16:0

Intervention Type DIETARY_SUPPLEMENT

Stearic acid

Experimental products are enriched with C18:0

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Apparently healthy men and post-menopausal women (post-menopausal for at least one year) as judged by study physician
* BMI ≥ 18.0 and ≤ 30.0 kg/m2
* Aged between 45 and 70 years
* Willing to comply to study protocol during study
* Having a general practitioner
* Agreeing to be informed about medically relevant personal test-results by a physician
* Informed consent signed
* Accessible veins on arms as determined by examination at screening

Exclusion Criteria

* Having a medical condition which might impact study measurements
* Use of over-the-counter and prescribed medication, which may interfere with study measurements
* Use of oral antibiotics in 40 days or less prior to the start of the study;
* Use of food supplements or plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study;
* Reported alcohol consumption ≥ 10 units/week (female) or ≥ 14 units/week (male);
* Reported intense sporting activities ≥ 10 hours/week;
* Reported weight loss or gain of 3 kg or more during a period of 2 months prior to screening
* Regular smokers (at least one cigarette (or equivalent) daily or \>7 cigarettes (or equivalent) weekly. Smokers who cannot comfortably restrain from smoking for up to 2 days will also be excluded
* Reported dietary habits: medically prescribed diet, allergy/intolerance to test products that will be provided during the study
* Blood donation in the past 3 months
* Drug abuse
* Reported participation in another nutritional or biomedical trial 3 months prior to screening
* Fasting triacylglycerol concentrations at screening: ≥ 4.5 mmol/L
* Serum lipids: treatment recommended according to the "Multidisciplinary guidelines Cardiovascular risk management"
* Fasting HbA1c ≥ 48 mmol/mol (or 6.5%)

Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes