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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
40
Biofortis Mérieux NutriSciences Clinical Investigation Center
Saint-Herblain, France
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
Time frame: 12 weeks
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
Time frame: 6 weeks
Changes in fasting blood oxidized LDL level
Defined as the difference V2 (6 weeks) - V1 (baseline) in mU/L
Time frame: 6 weeks
Changes in fasting blood oxidized LDL level
Defined as the difference V3 (12 weeks) - V1 (baseline) in mU/L
Time frame: 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
Time frame: 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
Time frame: 12 weeks
Changes in fasting blood concentrations of hsCRP
Defined as the difference V2 (6 weeks) - V1 (baseline) in mg/L
Time frame: 6 weeks
Changes in fasting blood concentrations of hsCRP
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Defined as the difference V3 (12 weeks) - V1 (baseline) in mg/L
Time frame: 12 weeks
Changes in fasting blood concentration of total free fatty acid
Defined as the difference V2 (6 weeks) - V1 (baseline) in mmol/L
Time frame: 6 weeks
Changes in fasting blood concentration of total free fatty acid
Defined as the difference V3 (12 weeks) - V1 (baseline) in mmol/L
Time frame: 12 weeks
Changes in fasting blood concentration of alkaline phosphatase
Defined as the difference V2 (6 weeks) - V1 (baseline) in µkat/L
Time frame: 6 weeks
Changes in fasting blood concentration of alkaline phosphatase
Defined as the difference V3 (12 weeks) - V1 (baseline) in µkat/L
Time frame: 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
Time frame: 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
Time frame: 12 weeks
Changes in fasting blood concentration of total antioxidant status
Defined as the difference V2 (6 weeks) - V1 (baseline) in mmol/L
Time frame: 6 weeks
Changes in fasting blood concentration of total antioxidant status
Defined as the difference V3 (12 weeks) - V1 (baseline) in mmol/L
Time frame: 12 weeks
Changes in concentration of urinary isoprostane (F2-isoprostane alpha)
Defined as the difference V2 (6 weeks) - V1 (baseline) in ng/mL
Time frame: 6 weeks
Changes in concentration of urinary isoprostane (F2-isoprostane alpha)
Defined as the difference V3 (12 weeks) - V1 (baseline) in ng/mL
Time frame: 12 weeks