NCT02352740

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

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

2 months

First QC Date

September 24, 2014

Last Update Submit

January 28, 2015

Conditions

Keywords

argininesupplementationmetabolic syndromenitric oxide

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'

EXPERIMENTAL

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

Dietary Supplement: A form ArginineDietary Supplement: B form Arginine

Healthy subjects

EXPERIMENTAL

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

Dietary Supplement: A form ArginineDietary Supplement: B form Arginine

Interventions

A form ArginineDIETARY_SUPPLEMENT

3 capsules containing 0.5g of A form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 week

Healthy subjectsHealthy subjects with 'hypertriglyceridemic waist'
B form ArginineDIETARY_SUPPLEMENT

3 capsules containing 0.5g of B form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 week

Healthy subjectsHealthy subjects with 'hypertriglyceridemic waist'

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

Centre de Recherche sur Volontaires (CRV), Hospital Avicenne

Bobigny, Île-de-France Region, 93000, France

Location

Related Publications (63)

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MeSH Terms

Conditions

OverweightHypertriglyceridemic WaistMetabolic Syndrome

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHypertriglyceridemiaHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism Disorders

Study Officials

  • Robert Benamouzig

    Hospital Avicenne

    PRINCIPAL INVESTIGATOR
  • François Mariotti, PhD

    AgroParisTech

    STUDY DIRECTOR

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

Locations