Algae and Cholesterol Absorption

Intestinal Cholesterol Absorption Clinical Trial

Official title:

Effects of Wakame and Spirulina Consumption on Intestinal Cholesterol Absorption in Non- Hypercholesterolemic Men and Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380611
• Other study ID #: METC 17-3-022
• Status: Completed
• Phase: N/A
• Start date: October 24, 2017
• Est. completion date: August 16, 2018

Study information

• Verified date: December 2017
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to investigate the effects of wakame and spirulina consumption on intestinal cholesterol absorption.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 16, 2018
• Est. primary completion date: August 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Cholesterol Absorption

Intervention

Dietary Supplement:
• Wakame
Consumption of 4.8 grams wakame per day for 17 days
• Spirulina
Consumption of 4.8 grams spirulina per day for 17 days
• Control
Consumption of microcrystalline cellulose for 17 days

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Markers for intestinal cholesterol absorption	Serum cholesterol-standardized campesterol concentrations will be measured as a marker for intestinal cholesterol absorption	Difference in outcomes between interventions and control at 17 days
Secondary	Lipids	Several markers for fasting lipid metabolism, including total cholesterol, LDL cholesterol and HDL cholesterol, will be measured in blood samples	Difference in outcomes between interventions and control at 17 days
Secondary	Markers for cholesterol synthesis	Serum cholesterol-standardized lathosterol and desmosterol concentrations will be measured as a markers for cholesterol synthesis	Difference in outcomes between interventions and control at 17 days
Secondary	Glucose concentrations	Fasting plasma glucose concentrations will be determined	Difference in outcomes between interventions and control at 17 days
Secondary	Blood pressure	Systolic and diastolic blood pressure will be determined	Difference in outcomes between interventions and control at 17 days