Dyslipidemia
Conditions
Keywords
Palmitic acid, Stearic acid, HDL-metabolism, Human intervention study
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.
Interventions
DIETARY_SUPPLEMENTPalmitic acid
Experimental products are enriched with C16:0
DIETARY_SUPPLEMENTStearic acid
Experimental products are enriched with C18:0
Sponsors
Unilever R&D
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
Yes
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%)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cholesterol efflux capacity after dietary period high in palmitic acid compared to dietary period high in stearic acid | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 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. |
| 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 | 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 | 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. |
Countries
Netherlands
Outcome results
None listed