Saturated Fatty Acids and HDL Metabolism

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Dyslipidemia

Treatments

Dietary Supplement: Palmitic acid

Dietary Supplement: Stearic acid

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02835651

METC 15-3-052

Details and patient eligibility

About

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.

Full description

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.

Enrollment

41 patients

Sex

All

Ages

45 to 70 years old

Volunteers

Accepts Healthy Volunteers

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%)