Characterization of the Metabolic Fate of an Oral Arginine Form
2 other identifiers
interventional
32
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 24, 2014
CompletedFirst Posted
Study publicly available on registry
February 2, 2015
CompletedFebruary 2, 2015
January 1, 2015
2 months
September 24, 2014
January 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Estimate of total conversion of a dose of oral arginine into NO
This assessment uses labelled arginine (\[15N2-(guanido)\]-arginine) for the first dose of arginine taken in the morning, and measurements of 15NO3 in urine for 24h. After administration of 15N-arginine, for each urine collection, we determined the nitrate excretion (from measurement of diuresis and nitrate concentration, by reactive chemiluminescence) and isotope 15N enrichment of nitrate ion (by microdiffusion technique and elementary analyzer connected to an isotope mass spectrometerEA-IRMS), to establish, by the principle of isotopic dilution, the total quantities of nitrate specifically from the ingested arginine. The sum of this excretion relative to the ingested dose determined the relative conversion of ingested arginine into NO.
Repeated measurement for 24h before (day 0) and after supplementation (day 8) for each treatment
Estimate of kinetic profiles of plasma arginine concentrations over 24 hours
Plasma AA concentrations were determined using an ultra-performance liquid chromatography-mass spectrometry system as previously described (Haque and al., 2012).
Repeated measurement for 24h before (day 0) and after supplementation (day 8) for each treatment
Secondary Outcomes (3)
Quantitative analysis of plasma markers of endothelial function
Before supplementation (day 0) and after supplementation (day 8) for each treatment
Estimate of kinetics use of arginine for NO and urea synthesis
Repeated measurement for 24h after supplementation (day 8) for each treament
Other quantitative analysis
Before supplementation (day 0) and after supplementation (day 8) for each treatment
Study Arms (2)
Healthy subjects with 'hypertriglyceridemic waist'
EXPERIMENTALSubjects with overweight, elevated waist circumference and elevated fasting triglyceridemia. Intervention : A form arginine and B form arginine
Healthy subjects
EXPERIMENTALControl subjects, i.e. without overweight, elevated waist circumference and elevated fasting triglyceridemia. Intervention : A form arginine and B form arginine
Interventions
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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 :
- Age between 18 to 60 years old
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnementlead
- Institut de Recherche Pierre Fabrecollaborator
- Hospital Avicennecollaborator
- Adeprinacollaborator
Study Sites (1)
Centre de Recherche sur Volontaires (CRV), Hospital Avicenne
Bobigny, Île-de-France Region, 93000, France
Related Publications (63)
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PMID: 27281799DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Benamouzig
Hospital Avicenne
- STUDY DIRECTOR
François Mariotti, PhD
AgroParisTech
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PU-PH in University Hospitals Paris-Seine-Saint-Denis-APHP-University Hospital Avicenne / Jean Verdier
Study Record Dates
First Submitted
September 24, 2014
First Posted
February 2, 2015
Study Start
March 1, 2013
Primary Completion
May 1, 2013
Last Updated
February 2, 2015
Record last verified: 2015-01