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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Evaluation of plasma Endothelin-1 of endothelial function in postprandial and fasting
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Obesity (BMI> 30 kg / m²)
- •Cardiac or vascular diseases
- •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
- •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.
研究组 & 干预措施
Healthy subjects with 'hypertriglyceridemic waist'
Subjects with overweight, elevated waist circumference and elevated fasting triglyceridemia.
Intervention: see below
干预措施: One form of arginine (Dietary Supplement)
Healthy subjects with 'hypertriglyceridemic waist'
Subjects with overweight, elevated waist circumference and elevated fasting triglyceridemia.
Intervention: see below
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
Evaluation of plasma Endothelin-1 of endothelial function in postprandial and fasting
时间窗: 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.
Physiological assessment of endothelial function in postprandial and fasting (Endothelial function was assessed by flow-mediated dilation (FMD) and peripheral arterial tonometry (EndoPAT)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Lipid profile analysis(Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment)
- Metabolomic analysis(Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment)
- 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)
研究者
Robert Benamouzig
PU-PH in University Hospitals Paris-Seine-Saint-Denis-APHP-University Hospital Avicenne / Jean Verdier
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement