Characterization of the Metabolic Fate of an Oral Arginine Form

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Status: Completed

Conditions: Overweight; Hypertriglyceridemic Waist

Treatments: Dietary Supplement: B form Arginine; Dietary Supplement: A form Arginine

Study type: Interventional

Funder types: Other

Identifiers

NCT02352740

FRMA12-1

2012-A00755-38 (Other Identifier)

Details and patient eligibility

About

The 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

Full description

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).

Enrollment: 32 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

32 participants in 2 patient groups

Healthy subjects with 'hypertriglyceridemic waist'

Experimental group

Description:

Subjects with overweight, elevated waist circumference and elevated fasting triglyceridemia. Intervention : A form arginine and B form arginine

Treatment:

Dietary Supplement: B form Arginine

Dietary Supplement: A form Arginine

Healthy subjects

Experimental group

Description:

Control subjects, i.e. without overweight, elevated waist circumference and elevated fasting triglyceridemia. Intervention : A form arginine and B form arginine

Treatment:

Dietary Supplement: B form Arginine

Dietary Supplement: A form Arginine