Characterization of the Metabolic Fate of an Oral L-arginine Form 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
- 32
- 试验地点
- 2
- 主要终点
- Estimate of total conversion of a dose of oral arginine into NO
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
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> 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 :
- •Inclusion Criteria:
- •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
- •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
结局指标
主要结局
Estimate of total conversion of a dose of oral arginine into NO
时间窗: Repeated measurement for 24h before (day 0) and after supplementation (day 8) for each treatment
This assessment uses labelled arginine (\[15N2-(guanido)\]-arginine) for the first dose of arginine taken in the morning, and measurements of 15NO3 in urine for 24h. After administration of 15N-arginine, for each urine collection, we determined the nitrate excretion (from measurement of diuresis and nitrate concentration, by reactive chemiluminescence) and isotope 15N enrichment of nitrate ion (by microdiffusion technique and elementary analyzer connected to an isotope mass spectrometerEA-IRMS), to establish, by the principle of isotopic dilution, the total quantities of nitrate specifically from the ingested arginine. The sum of this excretion relative to the ingested dose determined the relative conversion of ingested arginine into NO.
Estimate of kinetic profiles of plasma arginine concentrations over 24 hours
时间窗: Repeated measurement for 24h before (day 0) and after supplementation (day 8) for each treatment
Plasma AA concentrations were determined using an ultra-performance liquid chromatography-mass spectrometry system as previously described (Haque and al., 2012).
次要结局
- Other quantitative analysis(Before supplementation (day 0) and after supplementation (day 8) for each treatment)
- Quantitative analysis of plasma markers of endothelial function(Before supplementation (day 0) and after supplementation (day 8) for each treatment)
- Estimate of kinetics use of arginine for NO and urea synthesis(Repeated measurement for 24h after supplementation (day 8) for each treament)
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