Saturated Fatty Acids and HDL Metabolism

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835651
• Other study ID #: METC 15-3-052
• Status: Completed
• Phase: N/A
• First received: May 18, 2016
• Last updated: August 21, 2017
• Start date: April 14, 2016
• Est. completion date: July 1, 2017

Study information

• Verified date: March 2017
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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%)

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Dietary Supplement:
• Palmitic acid
Experimental products are enriched with C16:0
• Stearic acid
Experimental products are enriched with C18:0

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Unilever R&D

Country where clinical trial is conducted

Netherlands, 

Outcome

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