Title
Characterization of the Metabolic Fate of an Oral Arginine Form
Characterization of the Metabolic Fate of an Oral L-arginine Form in Healthy Subjects Featuring Risk Factors Related to the Metabolic Syndrome.
Phase
N/ALead Sponsor
Government of FranceStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Overweight Hypertriglyceridemic WaistIntervention/Treatment
arginine ...Study Participants
32The purpose of this study is to compare the metabolic fate of two oral forms of L-Arginine in healthy subjects featuring metabolic syndrome related risk factors
The study is a randomized crossover study including 16 healthy subjects with risk factors for metabolic syndrome and 16 healthy control subjects. According a double crossover design, each subject received two oral forms of L-arginine (A and B) in random order, and participated in a exploration day on the first day of arginine administration and after one week of supplementation with this arginine form. The two weeks of arginine supplementation were separated by a washout period of 2 weeks at least.
Each exploration extended over 24 hours after administration of the first arginine dose. Blood tests were performed at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 h after administration of the first dose. During explorations after the supplementation period, we also collected urine (0, 2, 4, 8, 12, 24 h after the first dose).
3 capsules containing 0.5g of A form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 week
3 capsules containing 0.5g of B form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 week
Subjects with overweight, elevated waist circumference and elevated fasting triglyceridemia. Intervention : A form arginine and B form arginine
Control subjects, i.e. without overweight, elevated waist circumference and elevated fasting triglyceridemia. Intervention : A form arginine and B form arginine
Healthy subjects with 'Hypertriglyceridemic waist' : Inclusion Criteria: Age between 18 to 60 years old Overweight (BMI between 25 and 30 kg/m²) 'Hypertriglyceridemic waist' (waist circumference > 94cm for men or > 88cm for women and fasting triglyceride levels > 150 mg/dL) Exclusion Criteria: Obesity (BMI> 30 kg / m²) Cardiac or vascular diseases Diabetes Thyroid disease Systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg Tobacco consumption > 6 cigarettes per week Alcohol consumption> 3 drinks per day Any medication (except contraceptive treatment) or dietary supplement intake that could not be arrested more than a week before the first visit for the duration of the study. Persons under guardianship Pregnancy (positive beta-hCG blood test) Positive serology HBsAg AcHbc, HCV and HIV Hemoglobin < 14 g/dl (for men) or <12 g / dl (for women) Participation in a clinical trial within 6 months preceding the study Healthy control subjects : Inclusion Criteria: Age between 18 to 60 years old Normal weight (BMI between 18.5 and 25 kg/m²) Waist circumference < 94cm for men or < 88cm for women and fasting triglyceride levels < 150 mg/dL Exclusion Criteria : Cardiac or vascular diseases Diabetes Thyroid disease Systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg Tobacco consumption > 6 cigarettes per week Alcohol consumption> 3 drinks per day Any medication (except contraceptive treatment) or dietary supplement intake that could not be arrested more than a week before the first visit for the duration of the study. Persons under guardianship Pregnancy (positive beta-hCG blood test) Positive serology HBsAg AcHbc, HCV and HIV Hemoglobin < 14 g/dl (for men) or <12 g / dl (for women) Participation in a clinical trial within 6 months preceding the study
