Status:
COMPLETED
Algae and Cholesterol Absorption
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Intestinal Cholesterol Absorption
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The primary objective of this study is to investigate the effects of wakame and spirulina consumption on intestinal cholesterol absorption.
Detailed Description
Objectives: Secondary objectives are to investigate the effects of wakame and spirulina consumption on fasting markers for lipid metabolism, glucose metabolism and blood pressure. Study design: Thi...
Eligibility Criteria
Inclusion
- 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
- Not willing to abstain from any algae and/or seaweed consumption or algae/seaweed containing products 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;
- 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;
- 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.
Key Trial Info
Start Date :
October 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03380611
Start Date
October 24 2017
End Date
August 16 2018
Last Update
October 19 2018
Active Locations (1)
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1
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229ER