Analysis of the Postprandial Effects of a Vegetable Protein Mixture Rich in Arginine, Cysteine and Leucine on Endothelial Dysfunction and Inflammation at Low Noise in Elderly People With Cardiometabolic Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Brachial artery Flow Mediated Dilation (FMD)
研究概览
简要总结
By 2050, the expanding world population will consume two-thirds more animal protein than it consumes today. The increase in chronic diseases associated with the generalization of these consumption patterns tend to understand the place of meat in our diets. All these elements participate to the reduction of animal proteins in favor of vegetable proteins in our food. The elderly are particularly affected by malnutrition, the prevalence of protein-energy malnutrition increasing with age and promoting the onset of morbidities. Without care, it leads to the worsening of physiological phenomena linked to aging such as loss of muscle functionality (sarcopenia) or reduction in bone density (osteoporosis) and increases the risk of falls - the main cause of dependence. However, in France, protein consumption declines significantly with age, even though requirements appear to be greater for the elderly. It is therefore a major challenge for our societies to ensure that the aging of the population and the increase in life expectancy are not synonymous with a reduction in the physical and mental capacities of individuals. Thus, it is essential to ensure that the recommendations for reducing the intake of animal proteins in favor of vegetable proteins can be applied without risk to aging populations, in particular on the human body cardiovascular risk of these populations.
详细描述
This human dietary intervention study is a double blind, randomized, placebo controlled, cross over trial with 3 arms, carried out on subjects with predisposition to cardiometabolic syndrome (based on weight circumference, blood triglyceride or blood cholesterol, glycemia and hypertension). This study aims to demonstrate transient improvement in vascular endothelial function (with Flow Mediated Dilatation (FMD) as main criteria) with consumption of vegetable proteins (rich in leucine, cysteine and arginine) by comparison with animal proteins and with a control without proteins.
The 33 recruited participants will receive the 3 yogurts in a random order. For each subject, the study is divided into 4 visits.
To summarize: Visit 1 (D-7) = inclusion, Visit 2 (D0: treatment period N°1), Visit 3 (D28 : treatment period N°2), Visit 4 (D56 : treatment period N°3). The wash-out periods between treatment period (duration: 4 weeks) may be extended until 5 weeks for the convenience of participants.
The protocol includes a total of 4 visits to PIC/CIC Inserm 1405 of the Clermont-Fd University Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Product kit (yogurt) will be labelled and packaged according to the pre-established randomization plane by the pharmacy department of University Hospital of Clermont-Ferrand, France. Kits will be distributed in a blind fashion for each cross over period on the basis of the randomization schedule.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Man or woman
- •65 years old and older (inclusive)
- •At least 2 of the following 4 cardiometabolic factors:
- •Waist circumference ≥88 cm for women, and ≥94 cm for men
- •Fasting triglyceridemia >1,5 g/L OR HDL level < 40 mg/dl for men, and < 50 mg/dl for women
- •Fasting blood glucose ≥ 100 mg/dl
- •Systolic blood pressure >130mmHg ou diastolic > 85 mm Hg
- •Accept not to change his lifestyle throughout the study
- •Accept to consume the same meal the day before exploration days, making sure to exclude non-recommended foods and agreeing to detail its content in a food diary
- •Ability to give informed consent to participate in research
- •Affiliation to Social Security
排除标准
- •Acute pathology (unstable or terminal pathology)
- •Renal failure (clearance <40 mL / min)
- •Asthma or chronic respiratory disease
- •Systolic or diastolic blood pressure in the judgement of the investigator
- •Diabetic (treated or not)
- •Treated with chemotherapy
- •Gastrointestinal, thyroid, cardiac or vascular illness in the judgement of the investigator
- •Biological examination no compatible with the study in the judgement of the investigator
- •Medical and/or surgical history no compatible with the study in the judgement of the investigator (previous cardiovascular events)
- •AgHbS, AcHbc, HCV and HIV positive serology
- •Concomitant treatment no compatible with the study in the judgement of the investigator
- •Diet or change in body mass > 2 kg in the 30 days before the study
- •Following a diet incompatible with the nutritional protocol (food intolerances, vegans, exclusion of certain food ingredients)
- •Allergies to any of the components of the test meals
- •Alcohol consumption> 2 glasses / day
- •Current smokers (> 6 cigarettes per week)
- •Subjects involved in another clinical trial or being in the exclusion period of another study or having received a total compensation greater than 4,500 euros over the 12 months preceding the start of the trial
- •Subject benefiting from a legal protection measure (curatorship, guardianship, safeguard of justice)
- •Refusal to participate
研究组 & 干预措施
Group/Cohort3
33 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt without any proteins (T) only once during the visit
干预措施: Animal proteins (AP) (Behavioral)
Group/Cohort2
33 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt rich in animal proteins (AP) only once during the visit
干预措施: Vegetable proteins (VP) rich in leucine, cystein, arginine (Behavioral)
Group/Cohort1
33 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt rich in cysteine, leucine and arginine (VP, vegetable proteins) only once during the visit
干预措施: Vegetable proteins (VP) rich in leucine, cystein, arginine (Behavioral)
Group/Cohort1
33 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt rich in cysteine, leucine and arginine (VP, vegetable proteins) only once during the visit
干预措施: Animal proteins (AP) (Behavioral)
Group/Cohort2
33 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt rich in animal proteins (AP) only once during the visit
干预措施: Animal proteins (AP) (Behavioral)
Group/Cohort2
33 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt rich in animal proteins (AP) only once during the visit
干预措施: No protein (T) (Behavioral)
Group/Cohort3
33 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt without any proteins (T) only once during the visit
干预措施: Vegetable proteins (VP) rich in leucine, cystein, arginine (Behavioral)
Group/Cohort3
33 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt without any proteins (T) only once during the visit
干预措施: No protein (T) (Behavioral)
Group/Cohort1
33 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt rich in cysteine, leucine and arginine (VP, vegetable proteins) only once during the visit
干预措施: No protein (T) (Behavioral)
结局指标
主要结局
Brachial artery Flow Mediated Dilation (FMD)
时间窗: Day 56 (V3) at T300min
The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.
Brachial artery Flow Mediated Dilation (FMD)
时间窗: Day 0 (V1) at T-30min
The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized.
Brachial artery Flow Mediated Dilation (FMD)
时间窗: Day 0 (V1) at T180min
The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.
Brachial artery Flow Mediated Dilation (FMD)
时间窗: Day 0 (V1) at T300min
The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.
Brachial artery Flow Mediated Dilation (FMD)
时间窗: Day 28 (V2) at T-30min
The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.
Brachial artery Flow Mediated Dilation (FMD)
时间窗: Day 28 (V2) at T180min
The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.
Brachial artery Flow Mediated Dilation (FMD)
时间窗: Day 28 (V2) at T300min
The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.
Brachial artery Flow Mediated Dilation (FMD)
时间窗: Day 56 (V3) at T-30min
The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.
Brachial artery Flow Mediated Dilation (FMD)
时间窗: Day 56 (V3) at T180min
The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.
次要结局
- Urine creatinine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Plasma Glucose dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma insulin dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Hyperaemia area by FLD(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Urine nitrate dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Plasma asymmetric dimethylarginine (ADMA) dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Rest flow by Flowmetry Laser Doppler (FLD)(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Urine nitrite dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Plasma creatinine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Hyperaemia area / occlusion area ratio by FLD(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Maximal flow by FLD(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Hyperaemia half time by FLD(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Plasma nitrate dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Plasma malondialdehyde (MDA) dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Urine symmetric dimethylarginine (SDMA) dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Plasma alanine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine alanine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma asparagine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Occlusion area by FLD(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Reactive Hyperemia - Peripheral Arterial Tonometry (RH-PAT)(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Urine malondialdehyde (MDA) dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Plasma nitrite dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Plasma N-epsilon-carboxy-ethyl lysine (CEL) dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma arginine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine arginine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine isoleucine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma leucine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine serine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma N-epsilon-carboxy-methyl lysine (CML) dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine N-epsilon-carboxy-ethyl lysine (CEL) dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine cysteine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine glycine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine methionine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma proline dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma threonine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma triglycerides dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- blood Peripheral Blood Mononuclear Cells (PBMC) count(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Questionnaire of acceptability(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine symmetric acetyl-lysine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine N-epsilon-carboxy-methyl lysine (CML) dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine asparagine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma histidine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine leucine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine lysine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma methionine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine proline dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma serine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine threonine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma tryptophan dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine asymmetric dimethylarginine (ADMA) dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Plasma symmetric dimethylarginine (SDMA) dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Plasma acetyl-lysine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3))
- Plasma glutamic acid dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine glutamic acid dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine glutamine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma glycine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma phenylalanine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine phenylalanine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine tryptophan dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine tyrosine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma Monocyte Chemoattractant Protein-1 (MCP-1) dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma InterCellular Adhesion Molecule 1 (ICAM-1) dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma aspartic acid dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine aspartic acid dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma cysteine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma glutamine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine histidine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma isoleucine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma lysine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma tyrosine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma Interleukin 1 bêta (IL-1β) dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma Tumor Necrosis Factor alpha (TNFα) dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma E-Selectine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Metabolome Sequencing of Plasma(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma valine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Urine valine dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Plasma Interleukin 6 (IL-6) dosage(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- Transcriptome Sequencing of Peripheral Blood Mononuclear Cells(Day 0 (V1), Day 28 (V2), Day 56 (V3).)
- PBMC production of Reactive Oxygen Species (ROS)(Day 0 (V1), Day 28 (V2), Day 56 (V3).)