Centre de Recherche sur Volontaires (CRV), Hospital Avicenne
Bobigny, Île-de-France Region, 93000, France
NCT Number: NCT02354794
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
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Bobigny, Île-de-France Region, 93000, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3 capsules containing 0.5g of one form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 month
3 capsules containing 0.5g cellulose (non active product) 3 times daily (4.5g per day) for 1 month
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Endothelial function was assessed by flow-mediated dilation (FMD) and peripheral arterial tonometry (EndoPAT).
FMD technique was used during the fasting test. The RHI measurements were performed the morning fasting and 2, 4, and 6 hours after administration of the high-fat meal, in the case of exploration days after supplementation. In terms of the 4h measurement, it was coupled to a FMD assessment.
FMD was calculated as the percentage change in artery diameter at peak dilation compared with baseline and is reported as a percentage.
The Reactive Hyperemia Index (RHI) was calculated as the ratio of the average pulse wave amplitude during hyperemia (60 to 120 s of the postocclusion period) to the average pulse wave amplitude during baseline in the occluded hand divided by the same values in the control hand and then multiplied by a baseline correction factor.
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Fasting plasma concentrations of VCAM-1 will be determined using two custom mixed assay kits with antibody-coated beads using the Luminex xMAP technology platform for multiplexing of immunochemical bioassays.
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Fasting plasma concentrations of ICAM-1 will be determined using two custom mixed assay kits with antibody-coated beads using the Luminex xMAP technology platform for multiplexing of immunochemical bioassays.
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Fasting plasma concentrations E-Selectin will be determined using two custom mixed assay kits with antibody-coated beads using the Luminex xMAP technology platform for multiplexing of immunochemical bioassays.
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Fasting plasma concentrations P-Selectin will be determined using two custom mixed assay kits with antibody-coated beads using the Luminex xMAP technology platform for multiplexing of immunochemical bioassays.
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Fasting plasma concentrations of PAI-1) will be determined using two custom mixed assay kits with antibody-coated beads using the Luminex xMAP technology platform for multiplexing of immunochemical bioassays.
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Fasting plasma concentrations of CRP will be determined using two custom mixed assay kits with antibody-coated beads using the Luminex xMAP technology platform for multiplexing of immunochemical bioassays.
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Fasting plasma concentrations of Endothelin-1 will be determined using two custom mixed assay kits with antibody-coated beads using the Luminex xMAP technology platform for multiplexing of immunochemical bioassays.
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Fasting amino acids contents was assayed by High-performance liquid chromatography (HPLC).
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Fasting nitrite were analyzed by Gas chromatography-mass spectrometry (GC-MS).
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Fasting and postprandial complete blood count (CBC) (was assayed using "classical clinical biochemical analyzers".
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
The fasting insulin and the fasting and postprandial glucose were assayed using "classical clinical biochemical analyzers".
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Fasting metabolomic analysis with metabolomic approaches
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Other
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02352740
Body Weight, Dyslipidemias
Bobigny, Île-de-France Region, France
View Trial DetailsNCT06866314
Body Weight, Glucose Metabolism Disorders
Izola, Municipality of Izola, Slovenia
View Trial DetailsNCT07065955
Autoimmune Diseases, Body Weight
Milan, Italy
View Trial DetailsNCT05627570
Body Weight, Cardiometabolic Syndrome
London, United Kingdom
View Trial Details