NCT02354794

Effect of Arginine Supplementation in the Metabolic Syndrome

Effect of Oral Supplementation With One Form of L-arginine on Vascular Endothelial Function in Healthy Subjects Featuring Risk Factors Related to the Metabolic Syndrome.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Overweight
• Hypertriglyceridemic Waist

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	One form of arginine	3 capsules containing 0.5g of one form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 month
DIETARY_SUPPLEMENT	placebo	3 capsules containing 0.5g cellulose (non active product) 3 times daily (4.5g per day) for 1 month

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-05-01
• Completion: 2014-09-01
• First posted: 2015-02-03
• Last updated: 2015-02-03

Locations

1 site across 1 country: France