Intestinal Cholesterol AbsorptionNCT03380611
Algae and Cholesterol Absorption
A study testing Wakame and Spirulina in people with Intestinal Cholesterol Absorption, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The primary objective of this study is to investigate the effects of wakame and spirulina consumption on intestinal cholesterol absorption. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Cholesterol Absorption
- What is being tested?
- Wakame and Spirulina
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Oct 2017to 16 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229ER
About this study
Official title: Effects of Wakame and Spirulina Consumption on Intestinal Cholesterol Absorption in Non- Hypercholesterolemic Men and Women
The primary objective of this study is to investigate the effects of wakame and spirulina consumption on intestinal cholesterol absorption.
Read the 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
- Being tested
- Wakame, Spirulina, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WakameDietary supplement
Also called Undaria pinnatifida
Consumption of 4.8 grams wakame per day for 17 days
SpirulinaDietary supplement
Also called Arthrospira
Consumption of 4.8 grams spirulina per day for 17 days
ControlDietary supplement
Consumption of microcrystalline cellulose for 17 days
| Study group | Role | What they receive |
|---|---|---|
| Wakame | Experimental | Subjects will receive capsules containing wakame Receives: Dietary Supplement: Wakame |
| Spirulina | Experimental | Subjects will receive capsules containing spirulina Receives: Dietary Supplement: Spirulina |
| Control | Placebo comparator | Subjects will receive capsules containing microcrystalline cellulose Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers for intestinal cholesterol absorption
Serum cholesterol-standardized campesterol concentrations will be measured as a marker for intestinal cholesterol absorption
Measured: Difference in outcomes between interventions and control at 17 days
Secondary outcomes (4)
Lipids
Several markers for fasting lipid metabolism, including total cholesterol, LDL cholesterol and HDL cholesterol, will be measured in blood samples
Measured: Difference in outcomes between interventions and control at 17 days
Markers for cholesterol synthesis
Serum cholesterol-standardized lathosterol and desmosterol concentrations will be measured as a markers for cholesterol synthesis
Measured: Difference in outcomes between interventions and control at 17 days
Glucose concentrations
Fasting plasma glucose concentrations will be determined
Measured: Difference in outcomes between interventions and control at 17 days
Blood pressure
Systolic and diastolic blood pressure will be determined
Measured: Difference in outcomes between interventions and control at 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start24 Oct 2017
- Primary completion16 Aug 2018
- Study completion16 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Cholesterol AbsorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald Mensink, Professor, Principal investigator, Maastricht University Medical CenterJogchum Plat, Professor, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380611
- Sponsor's protocol ID
- METC 17-3-022
- Status last verified
- Dec 2017
- First submitted
- 7 Dec 2017
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Wakame and Spirulina Consumption on Intestinal Cholesterol Absorption in Non- Hypercholesterolemic Men and Women
- ClinicalTrials.gov ID
- NCT03380611
- Acronym / sponsor ID
- METC 17-3-022
- Conditions
- Intestinal Cholesterol Absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 16 Aug 2018 (actual)
- Study completion
- 16 Aug 2018 (actual)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wakame | Experimental | Dietary Supplement: WakameSubjects will receive capsules containing wakame |
| Spirulina | Experimental | Dietary Supplement: SpirulinaSubjects will receive capsules containing spirulina |
| Control | Placebo comparator | Dietary Supplement: ControlSubjects will receive capsules containing microcrystalline cellulose |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WakameAlso: Undaria pinnatifidaConsumption of 4.8 grams wakame per day for 17 days | Dietary supplement | Wakame |
| SpirulinaAlso: ArthrospiraConsumption of 4.8 grams spirulina per day for 17 days | Dietary supplement | Spirulina |
| ControlConsumption of microcrystalline cellulose for 17 days | Dietary supplement | Control |
Primary outcome
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
4 secondary outcomes
Lipids
Time frame: Difference in outcomes between interventions and control at 17 days
Markers for cholesterol synthesis
Time frame: Difference in outcomes between interventions and control at 17 days
Glucose concentrations
Time frame: Difference in outcomes between interventions and control at 17 days
Blood pressure
Time frame: Difference in outcomes between interventions and control at 17 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
Related trials for Intestinal Cholesterol Absorption
Not yet recruiting
GPR146 and Cholesterol Metabolism
Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Mensink, Professor principal investigator
Maastricht University Medical Center
Jogchum Plat, Professor principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wakame and Spirulina in people with Intestinal Cholesterol Absorption, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Markers for intestinal cholesterol absorption (time frame: Difference in outcomes between interventions and control at 17 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.