Skip to content

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

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 - PASTEL (PAlmitic acid STEaric acid and Lipoproteins)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46224
Enrollment
43
Registered
2016-03-16
Start date
2016-04-14
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolisme HDL-metabolism risk factors for cardiovascular disease

Interventions

Subjects will receive both diets for 4 weeks with a wash-out period of 4 weeks in between. Contrast in the intakes of palmitic acid and stearic acid is 6% of energy. A postprandial test will be carr

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Apparently healthy men and post-menopausal women (post-menopausal for at least one year) - BMI * 18.0 and * 30.0 kg/m2 - Age: 45-70 yrs - Signed informed consent

Exclusion criteria

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 *Multidisciplinaire richtlijn Cardiovasculair risicomanagement* - Fasting HbA1c * 48 mmol/mol (or 6.5%)

Design outcomes

Primary

MeasureTime frame
The primary study parameter is the change in HDL metabolism during the fasted state at the end of the dietary period high in palmitic acid versus the dietary period high in stearic acid.

Secondary

MeasureTime frame
Secondary study parameters are the effects of palmitic acid versus stearic acid on fasting LDL-C, HDL-C, total cholesterol, the total cholesterol to HDL-C ratio, the LDL-C to HDL-C ratio, non-HDL cholesterol, apoAI and apoB100, and on fasted and postprandial triacylglycerol concentrations.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)