This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Collaborator:
Biofortis Mérieux NutriSciences
Information provided by (Responsible Party):
Algosource
ClinicalTrials.gov Identifier:
NCT02817620
First received: June 27, 2016
Last updated: September 15, 2017
Last verified: September 2017
  Purpose
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

Condition Intervention
Metabolic Syndrome Dietary Supplement: Spirulysat® Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Algosource:

Primary Outcome Measures:
  • Changes in the ratio of fasting blood concentrations oxidized LDL / total LDL cholesterol [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in mU/g


Secondary Outcome Measures:
  • Changes in the ratio of fasting blood concentrations oxidized LDL / total LDL cholesterol [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in mU/g

  • Changes in fasting blood oxidized LDL level [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in mU/L

  • Changes in fasting blood oxidized LDL level [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in mU/L

  • Changes in fasting blood concentrations of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in g/L

  • Changes in fasting blood concentrations of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in g/L

  • Changes in fasting blood concentrations of hsCRP [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in mg/L

  • Changes in fasting blood concentrations of hsCRP [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in mg/L

  • Changes in fasting blood concentration of total free fatty acid [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in mmol/L

  • Changes in fasting blood concentration of total free fatty acid [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in mmol/L

  • Changes in fasting blood concentration of alkaline phosphatase [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in µkat/L

  • Changes in fasting blood concentration of alkaline phosphatase [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in µkat/L

  • Changes in fasting blood concentrations of ASAT (Aspartate aminotransferase) and ALAT (alanine aminotransferase) [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in µkat/L

  • Changes in fasting blood concentrations of ASAT (Aspartate aminotransferase) and ALAT (alanine aminotransferase) [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in µkat/L

  • Changes in fasting blood concentration of total antioxidant status [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in mmol/L

  • Changes in fasting blood concentration of total antioxidant status [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in mmol/L

  • Changes in concentration of urinary isoprostane (F2-isoprostane alpha) [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in ng/mL

  • Changes in concentration of urinary isoprostane (F2-isoprostane alpha) [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in ng/mL


Other Outcome Measures:
  • Bile acids levels in stool (desoxycholic acid, lithocholic acid, cholic acid, chenodesoxycholic acid, bile salt, ursodesoxycholic acid) [ Time Frame: Baseline ]
  • Bile acids levels in stool (desoxycholic acid, lithocholic acid, cholic acid, chenodesoxycholic acid, bile salt, ursodesoxycholic acid) [ Time Frame: 6 weeks ]
  • Bile acids levels in stool (desoxycholic acid, lithocholic acid, cholic acid, chenodesoxycholic acid, bile salt, ursodesoxycholic acid) [ Time Frame: 12 weeks ]
  • Short chain fatty acids levels in stool (acetic acid, n-butyric acid, iso-butyric acid, n-valerianic acid, propionic acid) [ Time Frame: Baseline ]
  • Short chain fatty acids levels in stool (acetic acid, n-butyric acid, iso-butyric acid, n-valerianic acid, propionic acid) [ Time Frame: 6 weeks ]
  • Short chain fatty acids levels in stool (acetic acid, n-butyric acid, iso-butyric acid, n-valerianic acid, propionic acid) [ Time Frame: 12 weeks ]
  • Blood level of Glutathione peroxidase [ Time Frame: Baseline ]
  • Blood level of Glutathione peroxidase [ Time Frame: 6 weeks ]
  • Blood level of Glutathione peroxidase [ Time Frame: 12 weeks ]
  • Superoxide dismutase blood level [ Time Frame: Baseline ]
  • Superoxide dismutase blood level [ Time Frame: 6 weeks ]
  • Superoxide dismutase blood level [ Time Frame: 12 weeks ]
  • Catalase blood level [ Time Frame: Baseline ]
  • Catalase blood level [ Time Frame: 6 weeks ]
  • Catalase blood level [ Time Frame: 12 weeks ]
  • Intestinal microbiota (bacterial DNA extraction in stool) [ Time Frame: Baseline ]
  • Intestinal microbiota (bacterial DNA extraction in stool) [ Time Frame: 12 weeks ]
  • PON-1 (paraoxonase-1) in blood (arylesterase activity) [ Time Frame: Baseline ]
  • PON-1 (paraoxonase-1) in blood (arylesterase activity) [ Time Frame: 12 weeks ]
  • Body weight [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in kg

  • Body weight [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in kg

  • Total energy intake [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in kcal/day

  • Total energy intake [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in kcal/day

  • Percentage of energy intake from fat [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in %

  • Percentage of energy intake from fat [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in %

  • Percentage of energy intake from carbohydrates [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in %

  • Percentage of energy intake from carbohydrates [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in %

  • Percentage of energy intake from protein [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in %

  • Percentage of energy intake from protein [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in %

  • Dietary fiber intake [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in g/day (absolute quantities)

  • Dietary fiber intake [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in g/day (absolute quantities)

  • Saturated fatty acid intake [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in g/day (absolute quantities)

  • Saturated fatty acid intake [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in g/day (absolute quantities)

  • Mono-unsaturated fatty acid intake [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in g/day (absolute quantities)

  • Mono-unsaturated fatty acid intake [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in g/day (absolute quantities)

  • Poly-unsaturated fatty acid intake [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in g/day (absolute quantities)

  • Poly-unsaturated fatty acid intake [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in g/day (absolute quantities)

  • Heart rate (bpm) [ Time Frame: Pre-inclusion (V0), Baseline (V1), 6 weeks (V2) and 12 weeks (V3) ]
  • Systolic blood pressure (mmHg) [ Time Frame: Pre-inclusion (V0), Baseline (V1), 6 weeks (V2) and 12 weeks (V3) ]
  • Diastolic blood pressure (mmHg) [ Time Frame: Pre-inclusion (V0), Baseline (V1), 6 weeks (V2) and 12 weeks (V3) ]

Enrollment: 40
Actual Study Start Date: August 24, 2016
Study Completion Date: September 14, 2017
Primary Completion Date: September 14, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Spirulysat®
Food 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).
Dietary Supplement: Spirulysat®
Placebo Comparator: Placebo
Placebo 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).
Dietary Supplement: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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 ,
  • 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.

Exclusion Criteria:

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),
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02817620

Locations
France
Biofortis Mérieux NutriSciences Clinical Investigation Center
Saint Herblain, France, 44800
Sponsors and Collaborators
Algosource
Biofortis Mérieux NutriSciences
Investigators
Study Director: Sophie SCHMID Biofortis Mérieux NutriSciences
Principal Investigator: David GENDRE Biofortis Mérieux NutriSciences
  More Information

Responsible Party: Algosource
ClinicalTrials.gov Identifier: NCT02817620     History of Changes
Other Study ID Numbers: PEC15039
Study First Received: June 27, 2016
Last Updated: September 15, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017