OverweightNCT02354794
Effect of Arginine Supplementation in the Metabolic Syndrome
A study testing One form of arginine in people with Overweight and Hypertriglyceridemic Waist, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Hypertriglyceridemic Waist
- What is being tested?
- One form of arginine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 17Show fewer
- 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
- Contraindications to arginine intake, namely asthmatics subjects, people prone to herpes, patients with liver cirrhosis and renal failure
- Hypotensive patients for whom the use of nitroglycerin is contraindicated.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche sur Volontaires (CRV), Hospital Avicenne
Bobigny, Île-de-France Region, 93000
About this study
Official title: Effect of Oral Supplementation With One Form of L-arginine on Vascular Endothelial Function in Healthy Subjects Featuring Risk Factors Related to the Metabolic Syndrome.
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
Read the detailed description
The study is a randomized crossover study including 32 subjects with risk factors associated with metabolic syndrome. In a cross-over design, each subject received oral arginine and placebo, in a randomized order, and were studied the day preceding the first day of administration of arginine (or placebo) and after 4 weeks of arginine (or placebo) supplementation. The two periods of supplementation were separated by a washout period of at least 4 weeks.
The subject were studied in the morning (when before supplementation) and in a whole day (when after supplementation).
The mornings cessions consisted of fasting blood draw and vascular explorations, including a measurement of endothelium-dependent brachial artery reactivity ("Flow mediated dilation"), directly coupled to a measurement of post-ischemic digital reactivity (with the Endo-PAT method), completed by a measurement of non-endothelium-dependent brachial artery reactivity. An analysis of the pulse wave geometry was also performed.
The whole-day cession consisted of the same fasting vascular explorations. Blood tests were performed fasting and repeated 2, 4 and 6 h after ingestion of a high-fat meal (900 kcal). Measurements of Flow mediated dilation was repeated 4h and postischemic digital reactivity were repeated 2, 4 and 6 h after ingestion of the high fat meal.
- Conditions
- Overweight, Hypertriglyceridemic Waist
- Being tested
- One form of arginine, placebo
- Keywords
- arginine, supplementation, metabolic syndrome, endothelial function
- Medical subject headings
- Overweight, Hypertriglyceridemic Waist, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One form of arginineDietary supplement
3 capsules containing 0.5g of one form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 month
placeboDietary supplement
3 capsules containing 0.5g cellulose (non active product) 3 times daily (4.5g per day) for 1 month
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects with 'hypertriglyceridemic waist' | Experimental | Subjects with overweight, elevated waist circumference and elevated fasting triglyceridemia.
Intervention: see below Receives: Dietary Supplement: One form of arginine; Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
- Fasting ADMA concentrations were measured by an enzyme-linked immunosorbent assay.
Measured: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Amino acids measurement
Fasting amino acids contents was assayed by High-performance liquid chromatography (HPLC).
Measured: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Nitrite measurement
Fasting nitrite were analyzed by Gas chromatography-mass spectrometry (GC-MS).
Measured: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Complete blood count (CBC) analysis
Fasting and postprandial complete blood count (CBC) (was assayed using "classical clinical biochemical analyzers".
Measured: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Insulin and glucose measurement
The fasting insulin and the fasting and postprandial glucose were assayed using "classical clinical biochemical analyzers".
Measured: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Lipid profile analysis
- The fasting lipid profile (triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol) and the postprandial evolution of triglycerides were measured and were assayed using "classical clinical biochemical analyzers".
Measured: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Metabolomic analysis
Fasting metabolomic analysis with metabolomic approaches
Measured: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startFeb 2014
- Primary completionMay 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (76)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche Pierre Fabre, Hospital Avicenne, Adeprina
- Responsible party
- Principal investigator, Robert Benamouzig, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Investigators
- Robert Benamouzig, Principal investigator, Hospital AvicenneFrançois Mariotti, PhD, Study director, AgroParisTech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354794
- Sponsor's protocol ID
- FRMA13-1
- Other IDs
- 2013-A01043-42
- Status last verified
- Jan 2015
- First submitted
- 24 Sep 2014
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Abdelhamed AI, Reis SE, Sane DC, Brosnihan KB, Preli RB, Herrington DM. No effect of an L-arginine-enriched medical food (HeartBars) on endothelial function and platelet aggregation in subjects with hypercholesterolemia. Am Heart J. 2003 Mar;145(3):E15. doi: 10.1067/mhj.2003.160.
PubMed 12660684Adams MR, Forsyth CJ, Jessup W, Robinson J, Celermajer DS. Oral L-arginine inhibits platelet aggregation but does not enhance endothelium-dependent dilation in healthy young men. J Am Coll Cardiol. 1995 Oct;26(4):1054-61. doi: 10.1016/0735-1097(95)00257-9.
PubMed 7560599Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.
PubMed 19805654Arsenault BJ, Lemieux I, Despres JP, Wareham NJ, Kastelein JJ, Khaw KT, Boekholdt SM. The hypertriglyceridemic-waist phenotype and the risk of coronary artery disease: results from the EPIC-Norfolk prospective population study. CMAJ. 2010 Sep 21;182(13):1427-32. doi: 10.1503/cmaj.091276. Epub 2010 Jul 19.
PubMed 20643837Bai Y, Sun L, Yang T, Sun K, Chen J, Hui R. Increase in fasting vascular endothelial function after short-term oral L-arginine is effective when baseline flow-mediated dilation is low: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2009 Jan;89(1):77-84. doi: 10.3945/ajcn.2008.26544. Epub 2008 Dec 3.
PubMed 19056561Balkau B, Vernay M, Mhamdi L, Novak M, Arondel D, Vol S, Tichet J, Eschwege E; D.E.S.I.R. Study Group. The incidence and persistence of the NCEP (National Cholesterol Education Program) metabolic syndrome. The French D.E.S.I.R. study. Diabetes Metab. 2003 Nov;29(5):526-32. doi: 10.1016/s1262-3636(07)70067-8.
PubMed 14631330Barringer TA, Hatcher L, Sasser HC. Potential benefits on impairment of endothelial function after a high-fat meal of 4 weeks of flavonoid supplementation. Evid Based Complement Alternat Med. 2011;2011:796958. doi: 10.1093/ecam/nen048. Epub 2011 Jun 5.
PubMed 18955351Beaumier L, Castillo L, Ajami AM, Young VR. Urea cycle intermediate kinetics and nitrate excretion at normal and "therapeutic" intakes of arginine in humans. Am J Physiol. 1995 Nov;269(5 Pt 1):E884-96. doi: 10.1152/ajpendo.1995.269.5.E884.
PubMed 7491940Berkowitz DE, White R, Li D, Minhas KM, Cernetich A, Kim S, Burke S, Shoukas AA, Nyhan D, Champion HC, Hare JM; New Collective Author. Arginase reciprocally regulates nitric oxide synthase activity and contributes to endothelial dysfunction in aging blood vessels. Circulation. 2003 Oct 21;108(16):2000-6. doi: 10.1161/01.CIR.0000092948.04444.C7. Epub 2003 Sep 29.
PubMed 14517171Blackburn P, Lemieux I, Almeras N, Bergeron J, Cote M, Tremblay A, Lamarche B, Despres JP. The hypertriglyceridemic waist phenotype versus the National Cholesterol Education Program-Adult Treatment Panel III and International Diabetes Federation clinical criteria to identify high-risk men with an altered cardiometabolic risk profile. Metabolism. 2009 Aug;58(8):1123-30. doi: 10.1016/j.metabol.2009.03.012. Epub 2009 Jun 18.
PubMed 19481769Blackburn P, Lemieux I, Lamarche B, Bergeron J, Perron P, Tremblay G, Gaudet D, Despres JP. Hypertriglyceridemic waist: a simple clinical phenotype associated with coronary artery disease in women. Metabolism. 2012 Jan;61(1):56-64. doi: 10.1016/j.metabol.2011.05.017. Epub 2011 Jul 5.
PubMed 21733531Blum A, Hathaway L, Mincemoyer R, Schenke WH, Kirby M, Csako G, Waclawiw MA, Panza JA, Cannon RO 3rd. Effects of oral L-arginine on endothelium-dependent vasodilation and markers of inflammation in healthy postmenopausal women. J Am Coll Cardiol. 2000 Feb;35(2):271-6. doi: 10.1016/s0735-1097(99)00553-7.
PubMed 10676669Bode-Boger SM, Boger RH, Galland A, Tsikas D, Frolich JC. L-arginine-induced vasodilation in healthy humans: pharmacokinetic-pharmacodynamic relationship. Br J Clin Pharmacol. 1998 Nov;46(5):489-97. doi: 10.1046/j.1365-2125.1998.00803.x.
PubMed 9833603Bode-Boger SM, Muke J, Surdacki A, Brabant G, Boger RH, Frolich JC. Oral L-arginine improves endothelial function in healthy individuals older than 70 years. Vasc Med. 2003 May;8(2):77-81. doi: 10.1191/1358863x03vm474oa.
PubMed 14518608Bode-Boger SM. Effect of L-arginine supplementation on NO production in man. Eur J Clin Pharmacol. 2006;62:91-9
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Supplementation With One Form of L-arginine on Vascular Endothelial Function in Healthy Subjects Featuring Risk Factors Related to the Metabolic Syndrome.
- ClinicalTrials.gov ID
- NCT02354794
- Acronym / sponsor ID
- FRMA13-1
- Conditions
- Overweight, Hypertriglyceridemic Waist
- Keywords
- arginine, supplementation, metabolic syndrome, endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- Institut de Recherche Pierre Fabre, Hospital Avicenne, Adeprina
- Study start
- Feb 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The study is a randomized crossover study including 32 subjects with risk factors associated with metabolic syndrome. In a cross-over design, each subject received oral arginine and placebo, in a randomized order, and were studied the day preceding the first day of administration of arginine (or placebo) and after 4 weeks of arginine (or placebo) supplementation. The two periods of supplementation were separated by a washout period of at least 4 weeks.
The subject were studied in the morning (when before supplementation) and in a whole day (when after supplementation).
The mornings cessions consisted of fasting blood draw and vascular explorations, including a measurement of endothelium-dependent brachial artery reactivity ("Flow mediated dilation"), directly coupled to a measurement of post-ischemic digital reactivity (with the Endo-PAT method), completed by a measurement of non-endothelium-dependent brachial artery reactivity. An analysis of the pulse wave geometry was also performed.
The whole-day cession consisted of the same fasting vascular explorations. Blood tests were performed fasting and repeated 2, 4 and 6 h after ingestion of a high-fat meal (900 kcal). Measurements of Flow mediated dilation was repeated 4h and postischemic digital reactivity were repeated 2, 4 and 6 h after ingestion of the high fat meal.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects with 'hypertriglyceridemic waist' | Experimental | Dietary Supplement: One form of arginine, Dietary Supplement: placeboSubjects with overweight, elevated waist circumference and elevated fasting triglyceridemia. Intervention: see below |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (17 listed)
- Obesity (BMI> 30 kg / m²)
- Cardiac or vascular diseases
- Diabetes
- Thyroid disease
- Systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One form of arginine3 capsules containing 0.5g of one form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 month | Dietary supplement | Healthy subjects with 'hypertriglyceridemic waist' |
| placebo3 capsules containing 0.5g cellulose (non active product) 3 times daily (4.5g per day) for 1 month | Dietary supplement | Healthy subjects with 'hypertriglyceridemic waist' |
Primary outcome
Physiological assessment of endothelial function in postprandial and fasting (Endothelial function was assessed by flow-mediated dilation (FMD) and peripheral arterial tonometry (EndoPAT)
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
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.
Evaluation of plasma vascular cell adhesion molecule-1 (VCAM-1) of endothelial function in postprandial and fasting
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
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.
Evaluation of plasma intercellular adhesion molecule (ICAM-1) of endothelial function in postprandial and fasting
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
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.
Evaluation of plasma E-Selectin of endothelial function in postprandial and fasting
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
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.
Evaluation of plasma P-Selectin of endothelial function in postprandial and fasting
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
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.
Evaluation of plasma Plasminogen activator inhibitor-1 (PAI-1) of endothelial function in postprandial and fasting
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
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.
Evaluation of plasma C-reactive protein (CRP) of endothelial function in postprandial and fasting
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
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.
Evaluation of plasma Endothelin-1 of endothelial function in postprandial and fasting
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
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.
7 secondary outcomes
Asymmetric Dimethyl-L-Arginine (ADMA) measurement
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Amino acids measurement
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Nitrite measurement
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Complete blood count (CBC) analysis
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Insulin and glucose measurement
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Lipid profile analysis
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Metabolomic analysis
Time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
- Background: PubMed 12660684Abdelhamed AI, Reis SE, Sane DC, Brosnihan KB, Preli RB, Herrington DM. No effect of an L-arginine-enriched medical food (HeartBars) on endothelial function and platelet aggregation in subjects with hypercholesterolemia. Am Heart J. 2003 Mar;145(3):E15. doi: 10.1067/mhj.2003.160.
- Background: PubMed 7560599Adams MR, Forsyth CJ, Jessup W, Robinson J, Celermajer DS. Oral L-arginine inhibits platelet aggregation but does not enhance endothelium-dependent dilation in healthy young men. J Am Coll Cardiol. 1995 Oct;26(4):1054-61. doi: 10.1016/0735-1097(95)00257-9.
- Background: PubMed 19805654Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.
- Background: PubMed 20643837Arsenault BJ, Lemieux I, Despres JP, Wareham NJ, Kastelein JJ, Khaw KT, Boekholdt SM. The hypertriglyceridemic-waist phenotype and the risk of coronary artery disease: results from the EPIC-Norfolk prospective population study. CMAJ. 2010 Sep 21;182(13):1427-32. doi: 10.1503/cmaj.091276. Epub 2010 Jul 19.
- Background: PubMed 19056561Bai Y, Sun L, Yang T, Sun K, Chen J, Hui R. Increase in fasting vascular endothelial function after short-term oral L-arginine is effective when baseline flow-mediated dilation is low: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2009 Jan;89(1):77-84. doi: 10.3945/ajcn.2008.26544. Epub 2008 Dec 3.
- Background: PubMed 14631330Balkau B, Vernay M, Mhamdi L, Novak M, Arondel D, Vol S, Tichet J, Eschwege E; D.E.S.I.R. Study Group. The incidence and persistence of the NCEP (National Cholesterol Education Program) metabolic syndrome. The French D.E.S.I.R. study. Diabetes Metab. 2003 Nov;29(5):526-32. doi: 10.1016/s1262-3636(07)70067-8.
- Background: PubMed 18955351Barringer TA, Hatcher L, Sasser HC. Potential benefits on impairment of endothelial function after a high-fat meal of 4 weeks of flavonoid supplementation. Evid Based Complement Alternat Med. 2011;2011:796958. doi: 10.1093/ecam/nen048. Epub 2011 Jun 5.
- Background: PubMed 7491940Beaumier L, Castillo L, Ajami AM, Young VR. Urea cycle intermediate kinetics and nitrate excretion at normal and "therapeutic" intakes of arginine in humans. Am J Physiol. 1995 Nov;269(5 Pt 1):E884-96. doi: 10.1152/ajpendo.1995.269.5.E884.
- Background: PubMed 14517171Berkowitz DE, White R, Li D, Minhas KM, Cernetich A, Kim S, Burke S, Shoukas AA, Nyhan D, Champion HC, Hare JM; New Collective Author. Arginase reciprocally regulates nitric oxide synthase activity and contributes to endothelial dysfunction in aging blood vessels. Circulation. 2003 Oct 21;108(16):2000-6. doi: 10.1161/01.CIR.0000092948.04444.C7. Epub 2003 Sep 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Benamouzig principal investigator
Hospital Avicenne
François Mariotti, PhD study director
AgroParisTech
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One form of arginine in people with Overweight and Hypertriglyceridemic Waist, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological assessment of endothelial function in postprandial and fasting (Endothelial function was assessed by flow-mediated dilation (FMD) and peripheral arterial tonometry (EndoPAT) (time frame: Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02354794, which also lists 76 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2015.