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Completed

NCT Number: NCT02835651

Saturated Fatty Acids and HDL Metabolism

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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Key information

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6200 MD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

Palmitic acid

Dietary Supplement

Experimental products are enriched with C16:0

Stearic acid

Dietary Supplement

Experimental products are enriched with C18:0

Primary outcomes

  1. Cholesterol efflux capacity after dietary period high in palmitic acid compared to dietary period high in stearic acid

    Time frame: Cholesterol efflux is measured during fasted state at day 0, day 25 and day 28 of each intervention period.

    J774 Macrophages will be used to measure ex vivo cholesterol efflux capacity of HDL particles after a diet enriched with C16:0 or C18:0. Change in ex vivo cholesterol efflux capacity between the diets will be assessed using a linear mixed model with subject as random factor and day 0 as co-variant.

Secondary outcomes

  1. Change in fasted lipid metabolism markers between dietary period high in palmitic acid and dietary period high in stearic acid

    Time frame: Markers for lipid metabolism will be measured during fasted state at day 0, day 14, day 25 and day 28 of each intervention period

    Markers include fasting LDL-C [mmol/L], HDL-C [mmol/L], total cholesterol [mmol/L], non-HDL cholesterol [mmol/L] and triacylglycerol [mmol/L] concentrations. Change between diets will be assessed using a linear mixed model with subject as random factor and day 0 as co-variant.

  2. Change in fasted lipid ratios between dietary period high in palmitic acid and dietary period high in stearic acid

    Time frame: Markers for lipid metabolism will be measured during fasted state at day 0, day 14, day 25 and day 28 of each intervention period

    Markers include fasting total cholesterol to HDL-C ratio and LDL-C to HDL-C ratio. Change between diets will be assessed using a linear mixed model with subject as random factor and day 0 as co-variant.

  3. Change in fasted apolipoproteins between dietary period high in palmitic acid and dietary period high in stearic acid

    Time frame: Apolipoproteins will be measured during fasted state at day 0, day 14, day 25 and day 28 of each intervention period

    Apolipoproteins include fasting ApoA1 [μg/mL] and ApoB100 [μg/mL]. Change between diets will be assessed using a linear mixed model with subject as random factor and day 0 as co-variant.

  4. Change in postprandial triacylglycerol levels between dietary period high in palmitic acid and dietary period high in stearic acid

    Time frame: Triacylglycerol [mmol/L] is measured during postprandial state at day 28 (0 to 480 minutes after meal intake) of each intervention period

    Change between diets will be assessed using a linear mixed model with subject as random factor and day 0 as co-variant.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Unilever R&D

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 18, 2016
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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