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Saturated Fatty Acids and HDL Metabolism

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ClinicalTrials.gov Identifier: NCT02835651
Recruitment Status : Completed
First Posted : July 18, 2016
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
Unilever R&D
Information provided by (Responsible Party):
Maastricht University Medical Center

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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Dietary Supplement: Palmitic acid Dietary Supplement: Stearic acid Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : April 14, 2016
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Palmitic acid
Diet rich in palmitic acid
Dietary Supplement: Palmitic acid
Experimental products are enriched with C16:0

Experimental: Stearic acid
Diet rich in stearic acid
Dietary Supplement: Stearic acid
Experimental products are enriched with C18:0




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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%)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835651


Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
Unilever R&D
Investigators
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Principal Investigator: Ronald P Mensink, PhD Maastricht University

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02835651     History of Changes
Other Study ID Numbers: METC 15-3-052
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: March 2017

Keywords provided by Maastricht University Medical Center:
Palmitic acid
Stearic acid
HDL-metabolism
Human intervention study

Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Palmitic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action