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Effects of wakame and spirulina consumption on intestinal cholesterol absorption in non-hypercholesterolemic men and women

Effects of wakame and spirulina consumption on intestinal cholesterol absorption in non-hypercholesterolemic men and women - Algae and cholesterol absorption

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46515
Enrollment
37
Registered
2018-03-29
Start date
2017-10-24
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

cholesterol metabolisme cholesterol metabolism risk factors for cardiovascular diseases

Interventions

All subjects will receive wakame, spirulina and placebo capsules in randomized order. Subjects will be asked to consume 12 capsules per for 17 days, which is equal to 4.8 grams of wakame or spirulin
Intestinal cholesterol absorption

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * Apparently healthy men and women; * Aged between 18 and 70 years; * BMI between 18 and 30 kg/m2 * Non-smoking; * No elevated serum triacylglycerol concentrations (

Exclusion criteria

Exclusion criteria: * Not willing to abstain from any algae and/or seaweed consumption or algae/seaweed containing products (including sushi, see appendix I) two weeks before the start and during the trial; * Use of plant-sterol/stanol-enriched foods (e.g. Becel Proactive) or supplements in the four weeks prior to the screening and/or during the study; * Use of cholesterol or lipid-lowering medications (e.g. statins, bile-acid sequestrates, cholesterol absorption inhibitors); * Use of any kind of medication or a medically prescribed diet, which can interfere with the study (judged by the principal investigator); * Use of oral antibiotics in 40 days or less prior to the start of the study; * Use of food supplements that might interfere with study measurements (judged by the principal investigator) in four weeks or less prior to the start of the study; * Indications of treatment according to the Standard for Cardiovascular Risk Management from the Dutch General Practitioners community (NHG 2012); * Any medical condition that might interfere with study (measurements), judged by the principal investigator, including cardiovascular diseases or events (e.g. acute myocardial infarction or cerebro-vascular accident), diabetes, asthma, COPD, rheumatoid arthritis, and gastro-intestinal diseases (e.g. inflammatory bowel disease); * Unstable body weight (weight gain or loss > 3 kg in the past 3 months); * Females who are pregnant, breast feeding or who may wish to become pregnant during the study; * Consumption of > 14 (males) or > 10 (females) alcoholic consumptions a week; * Reported intense sporting activities > 10 hours a week; * Abuse of drugs; * Participation in any other biomedical trial four weeks prior to the screening visit; * Having donated >150 ml blood within 1 month prior to the screening visit, planning to donate blood during the study or within one month after finishing the study; * Impossible or difficult to puncture as evidenced during the screening visit.

Design outcomes

Primary

MeasureTime frame
The main study parameter is serum cholesterol-standardized campesterol concentration, measured at the end of each intervention period, which is a validated marker to measure intestinal cholesterol absorption.

Secondary

MeasureTime frame
Secondary study parameters are other markers for intestinal cholesterol absorption, markers for cholesterol and bile acid synthesis, markers for lipid metabolism, glucose and insulin concentrations, and fat-soluble vitamin concentrations will be assessed. The w3 index will be determined once in blood sampled via venipuncture and the dried blood spot system.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)