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

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

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Spirulysat®

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint Herblain, France, 44800
    • Biofortis Mérieux NutriSciences Clinical Investigation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 weeks
Changes in fasting blood oxidized LDL level	Defined as the difference V2 (6 weeks) - V1 (baseline) in mU/L	6 weeks
Changes in fasting blood oxidized LDL level	Defined as the difference V3 (12 weeks) - V1 (baseline) in mU/L	12 weeks
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	6 weeks
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	12 weeks
Changes in fasting blood concentrations of hsCRP	Defined as the difference V2 (6 weeks) - V1 (baseline) in mg/L	6 weeks
Changes in fasting blood concentrations of hsCRP	Defined as the difference V3 (12 weeks) - V1 (baseline) in mg/L	12 weeks
Changes in fasting blood concentration of total free fatty acid	Defined as the difference V2 (6 weeks) - V1 (baseline) in mmol/L	6 weeks
Changes in fasting blood concentration of total free fatty acid	Defined as the difference V3 (12 weeks) - V1 (baseline) in mmol/L	12 weeks
Changes in fasting blood concentration of alkaline phosphatase	Defined as the difference V2 (6 weeks) - V1 (baseline) in µkat/L	6 weeks
Changes in fasting blood concentration of alkaline phosphatase	Defined as the difference V3 (12 weeks) - V1 (baseline) in µkat/L	12 weeks
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	6 weeks
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	12 weeks
Changes in fasting blood concentration of total antioxidant status	Defined as the difference V2 (6 weeks) - V1 (baseline) in mmol/L	6 weeks
Changes in fasting blood concentration of total antioxidant status	Defined as the difference V3 (12 weeks) - V1 (baseline) in mmol/L	12 weeks
Changes in concentration of urinary isoprostane (F2-isoprostane alpha)	Defined as the difference V2 (6 weeks) - V1 (baseline) in ng/mL	6 weeks
Changes in concentration of urinary isoprostane (F2-isoprostane alpha)	Defined as the difference V3 (12 weeks) - V1 (baseline) in ng/mL	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bile acids levels in stool (desoxycholic acid, lithocholic acid, cholic acid, chenodesoxycholic acid, bile salt, ursodesoxycholic acid)		Baseline
Bile acids levels in stool (desoxycholic acid, lithocholic acid, cholic acid, chenodesoxycholic acid, bile salt, ursodesoxycholic acid)		6 weeks
Bile acids levels in stool (desoxycholic acid, lithocholic acid, cholic acid, chenodesoxycholic acid, bile salt, ursodesoxycholic acid)		12 weeks
Short chain fatty acids levels in stool (acetic acid, n-butyric acid, iso-butyric acid, n-valerianic acid, propionic acid)		Baseline
Short chain fatty acids levels in stool (acetic acid, n-butyric acid, iso-butyric acid, n-valerianic acid, propionic acid)		6 weeks
Short chain fatty acids levels in stool (acetic acid, n-butyric acid, iso-butyric acid, n-valerianic acid, propionic acid)		12 weeks
Blood level of Glutathione peroxidase		Baseline
Blood level of Glutathione peroxidase		6 weeks
Blood level of Glutathione peroxidase		12 weeks
Superoxide dismutase blood level		Baseline
Superoxide dismutase blood level		6 weeks
Superoxide dismutase blood level		12 weeks
Catalase blood level		Baseline
Catalase blood level		6 weeks
Catalase blood level		12 weeks
Intestinal microbiota (bacterial DNA extraction in stool)		Baseline
Intestinal microbiota (bacterial DNA extraction in stool)		12 weeks
PON-1 (paraoxonase-1) in blood (arylesterase activity)		Baseline
PON-1 (paraoxonase-1) in blood (arylesterase activity)		12 weeks
Body weight	Defined as the difference V2 (6 weeks) - V1 (baseline) in kg	6 weeks
Body weight	Defined as the difference V3 (12 weeks) - V1 (baseline) in kg	12 weeks
Total energy intake	Defined as the difference V2 (6 weeks) - V1 (baseline) in kcal/day	6 weeks
Total energy intake	Defined as the difference V3 (12 weeks) - V1 (baseline) in kcal/day	12 weeks
Percentage of energy intake from fat	Defined as the difference V2 (6 weeks) - V1 (baseline) in %	6 weeks
Percentage of energy intake from fat	Defined as the difference V3 (12 weeks) - V1 (baseline) in %	12 weeks
Percentage of energy intake from carbohydrates	Defined as the difference V2 (6 weeks) - V1 (baseline) in %	6 weeks
Percentage of energy intake from carbohydrates	Defined as the difference V3 (12 weeks) - V1 (baseline) in %	12 weeks
Percentage of energy intake from protein	Defined as the difference V2 (6 weeks) - V1 (baseline) in %	6 weeks
Percentage of energy intake from protein	Defined as the difference V3 (12 weeks) - V1 (baseline) in %	12 weeks
Dietary fiber intake	Defined as the difference V2 (6 weeks) - V1 (baseline) in g/day (absolute quantities)	6 weeks
Dietary fiber intake	Defined as the difference V3 (12 weeks) - V1 (baseline) in g/day (absolute quantities)	12 weeks
Saturated fatty acid intake	Defined as the difference V2 (6 weeks) - V1 (baseline) in g/day (absolute quantities)	6 weeks
Saturated fatty acid intake	Defined as the difference V3 (12 weeks) - V1 (baseline) in g/day (absolute quantities)	12 weeks
Mono-unsaturated fatty acid intake	Defined as the difference V2 (6 weeks) - V1 (baseline) in g/day (absolute quantities)	6 weeks
Mono-unsaturated fatty acid intake	Defined as the difference V3 (12 weeks) - V1 (baseline) in g/day (absolute quantities)	12 weeks
Poly-unsaturated fatty acid intake	Defined as the difference V2 (6 weeks) - V1 (baseline) in g/day (absolute quantities)	6 weeks
Poly-unsaturated fatty acid intake	Defined as the difference V3 (12 weeks) - V1 (baseline) in g/day (absolute quantities)	12 weeks
Heart rate (bpm)		Pre-inclusion (V0), Baseline (V1), 6 weeks (V2) and 12 weeks (V3)
Systolic blood pressure (mmHg)		Pre-inclusion (V0), Baseline (V1), 6 weeks (V2) and 12 weeks (V3)
Diastolic blood pressure (mmHg)		Pre-inclusion (V0), Baseline (V1), 6 weeks (V2) and 12 weeks (V3)

Collaborators and Investigators

• Sponsor: Algosource
• Collaborators: Biofortis Mérieux NutriSciences
• Investigators: Study Director: Sophie SCHMID, Biofortis Mérieux NutriSciences; Principal Investigator: David GENDRE, Biofortis Mérieux NutriSciences

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2016
• Primary Completion (Actual): September 14, 2017
• Study Completion (Actual): September 14, 2017

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 29, 2016

Study Record Updates

• Last Update Posted (Actual): September 18, 2017
• Last Update Submitted That Met QC Criteria: September 15, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: PEC15039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided