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

Completed

• Conditions: cholesterol metabolisme; cholesterol metabolism; risk factors for cardiovascular diseases

• Registration Number: NL-OMON46515
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 37

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 (< 4.5 mmol/L);
* Willing to comply to the study protocol during the study;
* Agreeing to be informed about medically relevant personal test-results.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is serum cholesterol-standardized campesterol<br /><br>concentration, measured at the end of each intervention period, which is a<br /><br>validated marker to measure intestinal cholesterol absorption. </p><br>

Secondary Outcome Measures

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