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Saturated Fatty Acids and HDL Metabolism

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Palmitic acid
Stearic acid
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dyslipidemia focused on measuring Palmitic acid, Stearic acid, HDL-metabolism, Human intervention study

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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%)

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Palmitic acid

Stearic acid

Arm Description

Diet rich in palmitic acid

Diet rich in stearic acid

Outcomes

Primary Outcome Measures

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

Change in fasted lipid metabolism markers between dietary period high in palmitic acid and dietary period high in stearic acid
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.
Change in fasted lipid ratios between dietary period high in palmitic acid and dietary period high in stearic acid
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.
Change in fasted apolipoproteins between dietary period high in palmitic acid and dietary period high in stearic acid
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.
Change in postprandial triacylglycerol levels between dietary period high in palmitic acid and dietary period high in stearic acid
Change between diets will be assessed using a linear mixed model with subject as random factor and day 0 as co-variant.

Full Information

First Posted
May 18, 2016
Last Updated
August 21, 2017
Sponsor
Maastricht University Medical Center
Collaborators
Unilever R&D
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1. Study Identification

Unique Protocol Identification Number
NCT02835651
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 14, 2016 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
July 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Unilever R&D

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
Keywords
Palmitic acid, Stearic acid, HDL-metabolism, Human intervention study

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Palmitic acid
Arm Type
Experimental
Arm Description
Diet rich in palmitic acid
Arm Title
Stearic acid
Arm Type
Experimental
Arm Description
Diet rich in stearic acid
Intervention Type
Dietary Supplement
Intervention Name(s)
Palmitic acid
Intervention Description
Experimental products are enriched with C16:0
Intervention Type
Dietary Supplement
Intervention Name(s)
Stearic acid
Intervention Description
Experimental products are enriched with C18:0
Primary Outcome Measure Information:
Title
Cholesterol efflux capacity after dietary period high in palmitic acid compared to dietary period high in stearic acid
Description
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.
Time Frame
Cholesterol efflux is measured during fasted state at day 0, day 25 and day 28 of each intervention period.
Secondary Outcome Measure Information:
Title
Change in fasted lipid metabolism markers between dietary period high in palmitic acid and dietary period high in stearic acid
Description
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.
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
Title
Change in fasted lipid ratios between dietary period high in palmitic acid and dietary period high in stearic acid
Description
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.
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
Title
Change in fasted apolipoproteins between dietary period high in palmitic acid and dietary period high in stearic acid
Description
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.
Time Frame
Apolipoproteins will be measured during fasted state at day 0, day 14, day 25 and day 28 of each intervention period
Title
Change in postprandial triacylglycerol levels between dietary period high in palmitic acid and dietary period high in stearic acid
Description
Change between diets will be assessed using a linear mixed model with subject as random factor and day 0 as co-variant.
Time Frame
Triacylglycerol [mmol/L] is measured during postprandial state at day 28 (0 to 480 minutes after meal intake) of each intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald P Mensink, PhD
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6200 MD
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
33733339
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.
Results Reference
derived
PubMed Identifier
32900520
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.
Results Reference
derived

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Saturated Fatty Acids and HDL Metabolism

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