Saturated Fatty Acids and HDL Metabolism

August 21, 2017 updated by: Maastricht University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6200 MD
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Cholesterol efflux is measured during fasted state at day 0, day 25 and day 28 of each intervention period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Markers for lipid metabolism will be measured during fasted state at day 0, day 14, day 25 and day 28 of each intervention period
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.
Markers for lipid metabolism will be measured during fasted state at day 0, day 14, day 25 and day 28 of each intervention period
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.
Apolipoproteins will be measured during fasted state at day 0, day 14, day 25 and day 28 of each intervention period
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.
Triacylglycerol [mmol/L] is measured during postprandial state at day 28 (0 to 480 minutes after meal intake) of each intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Unilever R&D

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimate)

July 18, 2016

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC 15-3-052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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