Algae and Cholesterol Absorption

NCT03380611 | Completed

• 1 other identifier: METC 17-3-022
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intestinal Cholesterol Absorption

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Lipids

  Difference in outcomes between interventions and control at 17 days

• Markers for cholesterol synthesis

  Difference in outcomes between interventions and control at 17 days

• Glucose concentrations

  Difference in outcomes between interventions and control at 17 days

• Blood pressure

  Difference in outcomes between interventions and control at 17 days

Study Arms (3)

Wakame

EXPERIMENTAL

Subjects will receive capsules containing wakame

Dietary Supplement: Wakame

Spirulina

EXPERIMENTAL

Subjects will receive capsules containing spirulina

Dietary Supplement: Spirulina

Control

PLACEBO COMPARATOR

Subjects will receive capsules containing microcrystalline cellulose

Dietary Supplement: Control

Interventions

Wakame DIETARY_SUPPLEMENT

Consumption of 4.8 grams wakame per day for 17 days

Also known as: Undaria pinnatifida

Wakame

Spirulina DIETARY_SUPPLEMENT

Consumption of 4.8 grams spirulina per day for 17 days

Also known as: Arthrospira

Spirulina

Control DIETARY_SUPPLEMENT

Consumption of microcrystalline cellulose for 17 days

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229ER, Netherlands

Location

Study Officials

• Ronald Mensink, Professor

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

• Jogchum Plat, Professor

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 21, 2017
• Study Start: October 24, 2017
• Primary Completion: August 16, 2018
• Study Completion: August 16, 2018
• Last Updated: October 19, 2018

Record last verified: 2017-12

Locations

NL (1)