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Metabolic SyndromeSPIROXNCT02817620

Study to Assess Antioxidant Efficacy of Spirulina on oxLDL and Lipids Metabolism on Subjects With Metabolic Syndrome

A study testing Spirulysat® in people with Metabolic Syndrome, run by Algosource at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this pilot study is to assess the beneficial effect of a spirulina water extract (product named Spirulysat®) compared to a placebo in the blood level ratio of oxidized LDL / total LDL cholesterol in subjects with metabolic syndrome after 12 weeks of consumption Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Metabolic Syndrome
What is being tested?
Spirulysat®
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteFrance
Study dates
24 Aug 2016to 14 Sep 2017
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • To be eligible to the study, male and female volunteers will have to fulfil the following criteria (assessment based on the medical examination performed at V0 with a checking at V1):
  • Age between 18 and 65 years (limits included),
  • BMI between 25 and 35 kg/m² (limits included),
  • With metabolic syndrome defined as central obesity : waist circumference > 94 cm for man and > 80 cm for woman associated to at least 2 observed criteria among : Fasting blood triglycerides > 1.5 g/L and/or Fasting blood HDL cholesterol < 0.4 g/L for man and < 0.5 g/L for woman and/or Fasting blood glucose level > 1 g/L and/or Arterial pressure > 130/85 mmHg or under antihypertensive treatment,
  • For women : non menopausal with the same reliable contraception since at least 3 months before the beginning of the study and agreeing to keep it during the entire duration of the study (condom with spermicide gel accepted) or menopausal without or with hormone replacement therapy started at stable dose since at least 3 months before the beginning of the study and agreeing to keep it during the entire duration of the study,
  • Weight stable with +/- 5 % in the last 3 months ,
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  • Non smoking or with tobacco consumption < 10 cigarettes / day,
  • Good general and mental health with in the opinion of the investigator : no clinically significant and relevant abnormalities of medical history or physical examination,
  • Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,
  • Affiliated with a social security scheme,
  • Agree to be registered on the volunteers in biomedical research file,
  • After V0 biological analysis the subjects will be eligible to the study on the following criterion :
  • Blood fasting lipid profile not requiring therapeutic intervention meaning professional recommendations (AFSSAPS, 2005).
  • A re-screening can occur from 2 months after the exit of the study for failure to comply with one or more of the inclusion criteria listed above.

Who cannot join

  • Volunteers with the following criteria will be considered as non eligible to the study (assessment based on the medical examination performed at V0 with a checking at V1):
  • Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal trouble...,
  • Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic or biliary disorders ongoing, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease),
  • With a history of ischemic cardiovascular event,
  • Having undergone recent surgical procedure (less than 6 months),
  • Suffering from an uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg),
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  • With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient,
  • Pregnant or lactating women or intending to become pregnant within 4 months ahead,
  • Under cholesterol and/or lipid-lowering treatment (e.g. statins, fibrates, ezetimibe, bile acid sequestrants, niacin, etc.) or stopped less than 3 months before the V0 visit,
  • Under medication which could affect blood lipid parameters (e.g. long-term corticosteroid systemic drug, systemic antibodies, androgens or enzyme inducers, etc.) or stopped less than 3 months before the V0 visit (antihypertensive stable long-term treatment tolerated),
  • Regular intake of dietary supplements or "functional foods" which are known to have an impact on lipid metabolism (e.g. rich in plant stanol or sterol like PRO-ACTIV or DANACOL products, red yeast rice, policosanol, capsules containing omega-3 fatty acids from fish oils, etc.) or stopped less than 3 months before the V0 visit,
  • Under treatment or dietary supplement which could significantly affect parameter(s) followed during the study according to the investigator or stopped in a too short period before the V0 visit,
  • With significant change in food habits or in physical activity in the 3 months before the V0 visit or not agreeing to keep them unchanged throughout the study,
  • With a current or planned in the next 4 months specific diet (hyper or hypocaloric, vegan, vegetarian...) or stopped less than 3 months before the V0 visit,
  • With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator,
  • Consuming more than 3 standard drinks of alcoholic beverage daily for men or 2 daily for women or not agreeing to keep his alcohol consumption habits unchanged throughout the study,
  • Having a lifestyle deemed incompatible with the study according to the investigator including high level physical activity (defined as more than 10 hours of significant physical activity a week, walking excluded),
  • Who made a blood donation in the 3 months before the V0 visit or intending to make it within 4 months ahead,
  • Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
  • Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 euros,
  • Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision,
  • Presenting a psychological or linguistic incapability to sign the informed consent,
  • Impossible to contact in case of emergency,
  • After V0 biological analysis the subjects will be considered as non eligible to the study on the following criteria :
  • Fasting blood triglycerides > 3.5 g/L (3.95 mmol/L),
  • Blood ASAT, ALAT or GGT (Gamma Glutamyl Transferase) > 3xULN (Upper Limit of Normal),
  • Blood urea > 12.11 mmol/L (value corresponding to 1.5xULN) or creatinine > 125 µmol/L,
  • Blood hsCRP > 10 mg/L,
  • Complete blood count with clinically significant abnormality according to the investigator.
  • A re-screening can occur from 2 months after the exit of the study for failure to comply with one or more of the exclusion criteria listed above.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Biofortis Mérieux NutriSciences Clinical Investigation Center

    Saint-Herblain, 44800

Other trials in France

About this study

Official title: Pilot Study to Assess Antioxidant Efficacy of a Spirulina Water Extract on Oxidized LDL Status and Lipids Metabolism on Subjects With Metabolic Syndrome

The purpose of this pilot study is to assess the beneficial effect of a spirulina water extract (product named Spirulysat®) compared to a placebo in the blood level ratio of oxidized LDL / total LDL cholesterol in subjects with metabolic syndrome after 12 weeks of consumption

Being tested
Spirulysat®, Placebo
Medical subject headings
Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spirulysat®Dietary supplement

  • PlaceboDietary supplement

Study groups in NCT02817620
Study groupRoleWhat they receive
Spirulysat®ExperimentalFood supplement packaged in 10 ml vials called Spirulysat®. This product is a phycocyanin concentrated fresh spirulina water extract (Spirulina Platensis). 2 vials daily to consume in the morning, just before the breakfast, in a glass of water, during 12 weeks (from V1 to V3 visit).
Receives: Dietary Supplement: Spirulysat®
PlaceboPlacebo comparatorPlacebo with the same characteristics, appearance, packaging and composition as the active formula except for active ingredient (Spirulina) replaced by a classical blue food colorant used to colour desserts. 2 vials daily to consume in the morning, just before the breakfast, in a glass of water, during 12 weeks (from V1 to V3 visit).
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the ratio of fasting blood concentrations oxidized LDL / total LDL cholesterol

    Defined as the difference V3 (12 weeks) - V1 (baseline) in mU/g

    Measured: 12 weeks

Secondary outcomes (17)

  1. Changes in the ratio of fasting blood concentrations oxidized LDL / total LDL cholesterol

    Defined as the difference V2 (6 weeks) - V1 (baseline) in mU/g

    Measured: 6 weeks

  2. Changes in fasting blood oxidized LDL level

    Defined as the difference V2 (6 weeks) - V1 (baseline) in mU/L

    Measured: 6 weeks

  3. Changes in fasting blood oxidized LDL level

    Defined as the difference V3 (12 weeks) - V1 (baseline) in mU/L

    Measured: 12 weeks

  4. Changes in fasting blood concentrations of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides

    Defined as the difference V2 (6 weeks) - V1 (baseline) in g/L

    Measured: 6 weeks

  5. Changes in fasting blood concentrations of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides

    Defined as the difference V3 (12 weeks) - V1 (baseline) in g/L

    Measured: 12 weeks

  6. Changes in fasting blood concentrations of hsCRP

    Defined as the difference V2 (6 weeks) - V1 (baseline) in mg/L

    Measured: 6 weeks

  7. Changes in fasting blood concentrations of hsCRP

    Defined as the difference V3 (12 weeks) - V1 (baseline) in mg/L

    Measured: 12 weeks

  8. Changes in fasting blood concentration of total free fatty acid

    Defined as the difference V2 (6 weeks) - V1 (baseline) in mmol/L

    Measured: 6 weeks

  9. Changes in fasting blood concentration of total free fatty acid

    Defined as the difference V3 (12 weeks) - V1 (baseline) in mmol/L

    Measured: 12 weeks

  10. Changes in fasting blood concentration of alkaline phosphatase

    Defined as the difference V2 (6 weeks) - V1 (baseline) in µkat/L

    Measured: 6 weeks

  11. Changes in fasting blood concentration of alkaline phosphatase

    Defined as the difference V3 (12 weeks) - V1 (baseline) in µkat/L

    Measured: 12 weeks

  12. Changes in fasting blood concentrations of ASAT (Aspartate aminotransferase) and ALAT (alanine aminotransferase)

    Defined as the difference V2 (6 weeks) - V1 (baseline) in µkat/L

    Measured: 6 weeks

  13. Changes in fasting blood concentrations of ASAT (Aspartate aminotransferase) and ALAT (alanine aminotransferase)

    Defined as the difference V3 (12 weeks) - V1 (baseline) in µkat/L

    Measured: 12 weeks

  14. Changes in fasting blood concentration of total antioxidant status

    Defined as the difference V2 (6 weeks) - V1 (baseline) in mmol/L

    Measured: 6 weeks

  15. Changes in fasting blood concentration of total antioxidant status

    Defined as the difference V3 (12 weeks) - V1 (baseline) in mmol/L

    Measured: 12 weeks

  16. Changes in concentration of urinary isoprostane (F2-isoprostane alpha)

    Defined as the difference V2 (6 weeks) - V1 (baseline) in ng/mL

    Measured: 6 weeks

  17. Changes in concentration of urinary isoprostane (F2-isoprostane alpha)

    Defined as the difference V3 (12 weeks) - V1 (baseline) in ng/mL

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2016 (estimated)
  2. Study start24 Aug 2016
  3. Primary completion14 Sep 2017
  4. Study completion14 Sep 2017

Resources

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02817620
Sponsor's protocol ID
PEC15039
Acronym
SPIROX
Status last verified
Sep 2017
First submitted
27 Jun 2016
Last updated
18 Sep 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Spirulysat® in people with Metabolic Syndrome, run by Algosource at 1 site in France.

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 14 inclusion and 30 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 18 Sep 2017. 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 France. 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?

Changes in the ratio of fasting blood concentrations oxidized LDL / total LDL cholesterol (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02817620.

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 18 Sep 2017.

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