Clinical trial NCT02835651: Saturated Fatty Acids and HDL Metabolism
Official title: Effects of C16:0 Versus C18:0 on HDL Metabolism and Other Cardiometabolic Risk Markers: A Dietary Intervention Study in Healthy Normal-weight and Overweight Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemia
Keywords: Palmitic acid
Stearic acid
HDL-metabolism
Human intervention study
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Unilever R&D
First posted: 2016-07-18
Enrollment: 41
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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%)

Primary outcomes:
measure: Cholesterol efflux capacity after dietary period high in palmitic acid compared to dietary period high in stearic acid
timeFrame: Cholesterol efflux is measured during fasted state at day 0, day 25 and day 28 of each intervention period.
Secondary outcomes:
measure: Change in fasted lipid metabolism markers between dietary period high in palmitic acid and dietary period high in stearic acid
timeFrame: Markers for lipid metabolism will be measured during fasted state at day 0, day 14, day 25 and day 28 of each intervention period
measure: Change in fasted lipid ratios between dietary period high in palmitic acid and dietary period high in stearic acid
timeFrame: Markers for lipid metabolism will be measured during fasted state at day 0, day 14, day 25 and day 28 of each intervention period
measure: Change in fasted apolipoproteins between dietary period high in palmitic acid and dietary period high in stearic acid
timeFrame: Apolipoproteins will be measured during fasted state at day 0, day 14, day 25 and day 28 of each intervention period
measure: Change in postprandial triacylglycerol levels between dietary period high in palmitic acid and dietary period high in stearic acid
timeFrame: Triacylglycerol [mmol/L] is measured during postprandial state at day 28 (0 to 480 minutes after meal intake) of each intervention period
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University
name: Ronald P Mensink, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Rooijen MA, Plat J, Zock PL, Blom WAM, Mensink RP. Effects of two consecutive mixed meals high in palmitic acid or stearic acid on 8-h postprandial lipemia and glycemia in healthy-weight and overweight men and postmenopausal women: a randomized controlled trial. Eur J Nutr. 2021 Oct;60(7):3659-3667. doi: 10.1007/s00394-021-02530-2. Epub 2021 Mar 17.
citation: van Rooijen MA, Plat J, Blom WAM, Zock PL, Mensink RP. Dietary stearic acid and palmitic acid do not differently affect ABCA1-mediated cholesterol efflux capacity in healthy men and postmenopausal women: A randomized controlled trial. Clin Nutr. 2021 Mar;40(3):804-811. doi: 10.1016/j.clnu.2020.08.016. Epub 2020 Aug 27.