Characterization of the Metabolic Fate of an Oral Arginine Form
NCT ID: NCT02352740
Last Updated: 2015-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2013-03-31
Brief Summary
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Detailed Description
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Each exploration extended over 24 hours after administration of the first arginine dose. Blood tests were performed at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 h after administration of the first dose. During explorations after the supplementation period, we also collected urine (0, 2, 4, 8, 12, 24 h after the first dose).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SINGLE
Study Groups
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Healthy subjects with 'hypertriglyceridemic waist'
Subjects with overweight, elevated waist circumference and elevated fasting triglyceridemia.
Intervention : A form arginine and B form arginine
A form Arginine
3 capsules containing 0.5g of A form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 week
B form Arginine
3 capsules containing 0.5g of B form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 week
Healthy subjects
Control subjects, i.e. without overweight, elevated waist circumference and elevated fasting triglyceridemia.
Intervention : A form arginine and B form arginine
A form Arginine
3 capsules containing 0.5g of A form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 week
B form Arginine
3 capsules containing 0.5g of B form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 week
Interventions
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A form Arginine
3 capsules containing 0.5g of A form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 week
B form Arginine
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
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Inclusion Criteria
* 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)
* Age between 18 to 60 years old
* Normal weight (BMI between 18.5 and 25 kg/m²)
* Waist circumference \< 94cm for men or \< 88cm for women and fasting triglyceride levels \< 150 mg/dL
Exclusion Criteria
* 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 :
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Institut de Recherche Pierre Fabre
OTHER
Hospital Avicenne
OTHER
Adeprina
OTHER
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
OTHER
Responsible Party
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Robert Benamouzig
PU-PH in University Hospitals Paris-Seine-Saint-Denis-APHP-University Hospital Avicenne / Jean Verdier
Principal Investigators
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Robert Benamouzig
Role: PRINCIPAL_INVESTIGATOR
Hospital Avicenne
François Mariotti, PhD
Role: STUDY_DIRECTOR
AgroParisTech
Locations
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Centre de Recherche sur Volontaires (CRV), Hospital Avicenne
Bobigny, Île-de-France Region, France
Countries
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References
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Other Identifiers
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2012-A00755-38
Identifier Type: OTHER
Identifier Source: secondary_id
FRMA12-1
Identifier Type: -
Identifier Source: org_study_id
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