Effect of Arginine Supplementation in the Metabolic Syndrome

NCT02354794 | Completed

• 2 other identifiers: FRMA13-12013-A01043-42
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overweight; Hypertriglyceridemic Waist

Keywords

arginine; supplementation; metabolic syndrome; endothelial function

Outcome Measures

Primary Outcomes (8)

• Physiological assessment of endothelial function in postprandial and fasting (Endothelial function was assessed by flow-mediated dilation (FMD) and peripheral arterial tonometry (EndoPAT)

  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.

  Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment

• Evaluation of plasma vascular cell adhesion molecule-1 (VCAM-1) of endothelial function in postprandial and fasting

  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.

  Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment

• Evaluation of plasma intercellular adhesion molecule (ICAM-1) of endothelial function in postprandial and fasting

  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.

  Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment

• Evaluation of plasma E-Selectin of endothelial function in postprandial and fasting

  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.

  Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment

• Evaluation of plasma P-Selectin of endothelial function in postprandial and fasting

  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.

  Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment

• Evaluation of plasma Plasminogen activator inhibitor-1 (PAI-1) of endothelial function in postprandial and fasting

  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.

  Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment

• Evaluation of plasma C-reactive protein (CRP) of endothelial function in postprandial and fasting

  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.

  Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment

• Evaluation of plasma Endothelin-1 of endothelial function in postprandial and fasting

  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.

  Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment

Secondary Outcomes (7)

• Asymmetric Dimethyl-L-Arginine (ADMA) measurement

  Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment

• Amino acids measurement

  Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment

• Nitrite measurement

  Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment

• Complete blood count (CBC) analysis

  Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment

• Insulin and glucose measurement

  Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment

Study Arms (1)

Healthy subjects with 'hypertriglyceridemic waist'

EXPERIMENTAL

Subjects with overweight, elevated waist circumference and elevated fasting triglyceridemia. Intervention: see below

Dietary Supplement: One form of arginine; Dietary Supplement: placebo

Interventions

One form of arginine DIETARY_SUPPLEMENT

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

Healthy subjects with 'hypertriglyceridemic waist'

placebo DIETARY_SUPPLEMENT

3 capsules containing 0.5g cellulose (non active product) 3 times daily (4.5g per day) for 1 month

Healthy subjects with 'hypertriglyceridemic waist'

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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\> 2 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
• Positive Hepatitis B virus (HBV), Hepatitis C virus (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
• Pregnant and lactating women
• For women, menstrual cycle with a duration different from 28 (± 1) days (the cycle is not controlled by a contraceptive treatment at 28 days, or he does not appear spontaneously with regularity)
• Subjects with allergies to final product components

Sponsors & Collaborators

• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: lead
• Institut de Recherche Pierre Fabre: collaborator
• Hospital Avicenne: collaborator
• Adeprina: collaborator

Study Sites (1)

Centre de Recherche sur Volontaires (CRV), Hospital Avicenne

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

Location

Related Publications (76)

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MeSH Terms

Conditions

Overweight; Hypertriglyceridemic Waist; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypertriglyceridemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose 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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• 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 3, 2015
• Study Start: February 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 3, 2015

Record last verified: 2015-01

Locations

FR (1)