Saturated Fatty Acids and HDL Metabolism

NCT02835651 | Completed

• 1 other identifier: METC 15-3-052
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemia

Keywords

Palmitic acid; Stearic acid; HDL-metabolism; Human intervention study

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (4)

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

  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

  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

  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

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

Study Arms (2)

Palmitic acid

EXPERIMENTAL

Diet rich in palmitic acid

Dietary Supplement: Palmitic acid

Stearic acid

EXPERIMENTAL

Diet rich in stearic acid

Dietary Supplement: Stearic acid

Interventions

Palmitic acid DIETARY_SUPPLEMENT

Experimental products are enriched with C16:0

Palmitic acid

Stearic acid DIETARY_SUPPLEMENT

Experimental products are enriched with C18:0

Stearic acid

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Unilever R&D: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6200 MD, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 33733339 DERIVED

• 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.

  PMID: 32900520 DERIVED

MeSH Terms

Conditions

Dyslipidemias

Interventions

Palmitic Acid; stearic acid

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Palmitic Acids; Fatty Acids; Lipids

Study Officials

• Ronald P Mensink, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: July 18, 2016
• Study Start: April 14, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-03

Locations

NL (1)