Algae and Cholesterol Absorption

NCT ID: NCT03380611

Last Updated: 2018-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-24
• Study Completion Date: 2018-08-16

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.

Conditions

Intestinal Cholesterol Absorption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Wakame

Subjects will receive capsules containing wakame

Group Type: EXPERIMENTAL

Wakame

Intervention Type: DIETARY_SUPPLEMENT

Consumption of 4.8 grams wakame per day for 17 days

Spirulina

Subjects will receive capsules containing spirulina

Group Type: EXPERIMENTAL

Spirulina

Intervention Type: DIETARY_SUPPLEMENT

Consumption of 4.8 grams spirulina per day for 17 days

Control

Subjects will receive capsules containing microcrystalline cellulose

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DIETARY_SUPPLEMENT

Consumption of microcrystalline cellulose for 17 days

Interventions

Wakame

Consumption of 4.8 grams wakame per day for 17 days

Intervention Type: DIETARY_SUPPLEMENT

Spirulina

Consumption of 4.8 grams spirulina per day for 17 days

Intervention Type: DIETARY_SUPPLEMENT

Control

Consumption of microcrystalline cellulose for 17 days

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Undaria pinnatifida; Arthrospira

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Mensink, Professor

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Jogchum Plat, Professor

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

METC 17-3-022

Identifier Type: -

Identifier Source: org_study_id