Effect of Arginine Supplementation in the Metabolic Syndrome

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

Status

Completed

Conditions

Overweight

Hypertriglyceridemic Waist

Treatments

Dietary Supplement: One form of arginine

Dietary Supplement: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02354794

FRMA13-1

2013-A01043-42 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether oral supplementation with one form of arginine improves vascular endothelial function in healthy subjects with risk factors associated with the metabolic syndrome

Full description

The study is a randomized crossover study including 32 subjects with risk factors associated with metabolic syndrome. In a cross-over design, each subject received oral arginine and placebo, in a randomized order, and were studied the day preceding the first day of administration of arginine (or placebo) and after 4 weeks of arginine (or placebo) supplementation. The two periods of supplementation were separated by a washout period of at least 4 weeks.

The subject were studied in the morning (when before supplementation) and in a whole day (when after supplementation).

The mornings cessions consisted of fasting blood draw and vascular explorations, including a measurement of endothelium-dependent brachial artery reactivity ("Flow mediated dilation"), directly coupled to a measurement of post-ischemic digital reactivity (with the Endo-PAT method), completed by a measurement of non-endothelium-dependent brachial artery reactivity. An analysis of the pulse wave geometry was also performed.

The whole-day cession consisted of the same fasting vascular explorations. Blood tests were performed fasting and repeated 2, 4 and 6 h after ingestion of a high-fat meal (900 kcal). Measurements of Flow mediated dilation was repeated 4h and postischemic digital reactivity were repeated 2, 4 and 6 h after ingestion of the high fat meal.

Enrollment

36 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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> 2 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
Positive Hepatitis B virus (HBV), Hepatitis C virus (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
Pregnant and lactating women
For women, menstrual cycle with a duration different from 28 (± 1) days (the cycle is not controlled by a contraceptive treatment at 28 days, or he does not appear spontaneously with regularity)
Subjects with allergies to final product components
Contraindications to arginine intake, namely asthmatics subjects, people prone to herpes, patients with liver cirrhosis and renal failure
Hypotensive patients for whom the use of nitroglycerin is contraindicated.