Characterization of the Metabolic Fate of an Oral Arginine Form

NCT ID: NCT02352740

Last Updated: 2015-02-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Brief Summary

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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

Detailed Description

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The study is a randomized crossover study including 16 healthy subjects with risk factors for metabolic syndrome and 16 healthy control subjects. According a double crossover design, each subject received two oral forms of L-arginine (A and B) in random order, and participated in a exploration day on the first day of arginine administration and after one week of supplementation with this arginine form. The two weeks of arginine supplementation were separated by a washout period of 2 weeks at least.

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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Overweight Hypertriglyceridemic Waist

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

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

Group Type EXPERIMENTAL

A form Arginine

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_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 subjects

Control subjects, i.e. without overweight, elevated waist circumference and elevated fasting triglyceridemia.

Intervention : A form arginine and B form arginine

Group Type EXPERIMENTAL

A form Arginine

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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)


* 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

* 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 :


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut de Recherche Pierre Fabre

OTHER

Sponsor Role collaborator

Hospital Avicenne

OTHER

Sponsor Role collaborator

Adeprina

OTHER

Sponsor Role collaborator

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

OTHER

Sponsor Role lead

Responsible Party

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Robert Benamouzig

PU-PH in University Hospitals Paris-Seine-Saint-Denis-APHP-University Hospital Avicenne / Jean Verdier

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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France

References

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Reference Type DERIVED
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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012-A00755-38

Identifier Type: OTHER

Identifier Source: secondary_id

FRMA12-1

Identifier Type: -

Identifier Source: org_study_id

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