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Algae and Cholesterol Absorption

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ClinicalTrials.gov Identifier: NCT03380611
Recruitment Status : Completed
First Posted : December 21, 2017
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

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

Condition or disease Intervention/treatment Phase
Intestinal Cholesterol Absorption Dietary Supplement: Wakame Dietary Supplement: Spirulina Dietary Supplement: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Wakame and Spirulina Consumption on Intestinal Cholesterol Absorption in Non- Hypercholesterolemic Men and Women
Actual Study Start Date : October 24, 2017
Actual Primary Completion Date : August 16, 2018
Actual Study Completion Date : August 16, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Wakame
Subjects will receive capsules containing wakame
Dietary Supplement: Wakame
Consumption of 4.8 grams wakame per day for 17 days
Other Name: Undaria pinnatifida

Experimental: Spirulina
Subjects will receive capsules containing spirulina
Dietary Supplement: Spirulina
Consumption of 4.8 grams spirulina per day for 17 days
Other Name: Arthrospira

Placebo Comparator: Control
Subjects will receive capsules containing microcrystalline cellulose
Dietary Supplement: Control
Consumption of microcrystalline cellulose for 17 days




Primary Outcome Measures :
  1. Markers for intestinal cholesterol absorption [ Time Frame: Difference in outcomes between interventions and control at 17 days ]
    Serum cholesterol-standardized campesterol concentrations will be measured as a marker for intestinal cholesterol absorption


Secondary Outcome Measures :
  1. Lipids [ Time Frame: Difference in outcomes between interventions and control at 17 days ]
    Several markers for fasting lipid metabolism, including total cholesterol, LDL cholesterol and HDL cholesterol, will be measured in blood samples

  2. Markers for cholesterol synthesis [ Time Frame: Difference in outcomes between interventions and control at 17 days ]
    Serum cholesterol-standardized lathosterol and desmosterol concentrations will be measured as a markers for cholesterol synthesis

  3. Glucose concentrations [ Time Frame: Difference in outcomes between interventions and control at 17 days ]
    Fasting plasma glucose concentrations will be determined

  4. Blood pressure [ Time Frame: Difference in outcomes between interventions and control at 17 days ]
    Systolic and diastolic blood pressure will be determined



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380611


Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229ER
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Ronald Mensink, Professor Maastricht University Medical Center
Principal Investigator: Jogchum Plat, Professor Maastricht University Medical Center
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03380611    
Other Study ID Numbers: METC 17-3-022
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No