Clinical trial NCT03380611: Algae and Cholesterol Absorption
Official title: Effects of Wakame and Spirulina Consumption on Intestinal Cholesterol Absorption in Non- Hypercholesterolemic Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Cholesterol Absorption
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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:

This study is a double-blinded, randomized, placebo-controlled, crossover intervention trial consisting of three intervention periods of 17 days each, separated by a minimum washout period of 14 days.

Study population:

The study population will consist of 37 healthy, non-hypercholesterolemic men and women aged between 18 and 70 years.

Intervention:

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

Eligibility criteria: Inclusion Criteria:

* 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 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.

Primary outcomes:
measure: Markers for intestinal cholesterol absorption
timeFrame: Difference in outcomes between interventions and control at 17 days
Secondary outcomes:
measure: Lipids
timeFrame: Difference in outcomes between interventions and control at 17 days
measure: Markers for cholesterol synthesis
timeFrame: Difference in outcomes between interventions and control at 17 days
measure: Glucose concentrations
timeFrame: Difference in outcomes between interventions and control at 17 days
measure: Blood pressure
timeFrame: Difference in outcomes between interventions and control at 17 days
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Ronald Mensink, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Jogchum Plat, Professor
role: PRINCIPAL_INVESTIGATOR
References: