Single-blind, Randomized, Cross-over Comparative Bioavailability Study About the Kinetics of Plasma Amino Acid Concentrations Subsequent to the Consumption of Innovative Legume-based Products.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Changes in the plasma concentrations of leucinemia
研究概览
简要总结
The use of pea proteins could be interesting in specific foods. Indeed, these proteins could have great nutritional quality, with good amino acid profile. Therefore, the investigators study the bioavailability of protein and post-prandial variation of metabolic markers following consumption of pea protein-enriched products in healthy young subjects.
Main Objective is to compare plasma kinetics of leucine.
详细描述
The written agreement of the subjects will be obtained after information on the aims, nature and possible risks of the study.
Before inclusion, the volunteers will be subjected to a medical check-up at the Nutritional Exploration Unit which includes an examination of personal and family history and current drug treatments, as well as a standard medical examination and a blood test for a biological check-up. Compliance with the inclusion/ exclusion criteria will be verified during this review.
Volunteers included in the protocol will go to the Clinical Pharmacology Center (CPC) to perform the tests. At each visit, each volunteer will receive one of the six products.
The volunteer will be reviewed six times for the realization of a kinetics. First, three visits will be made with at least 7 days apart (wash out period). Then, after a 15-day break, three others visits will be organized spaced at least 7 days apart. The day before each visit, the evening meal will be standardized and eaten before 9 pm. A short catheter will be placed in a vein in the forearm for blood samples. After a fasting blood sample (T0), the subjects will consume one of the test meals. Nine samples will be then collected at several times after meal ingestion.
On these samples, plasma concentrations of amino acids, insulin, blood sugar, lipid balance and inflammatory markers will be measured. Any intercurrent events will be noted in the observation book. The test meal sequence will be randomly assigned to subjects (generating a random list) prior to the start of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
single-centre randomized, cross-over controlled trial.
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Major male volunteers under 30 (<30)
- •Body mass index between 22 and 28 kg/m²
- •Subjects considered healthy by investigator based on the examination, medical and clinical examination,
- •biological check up considered compatible with study participation
- •person who is in the position to sign informed consent
排除标准
- •Subject with a particular diet (vegetarians, vegans, nutritional supplements, etc.),
- •Subject weight < 60 kg
- •Subject refusing to consume one of the proposed products or the test meal
- •Subject with a food allergy(s) to one or more components of the study products (gluten, legumes, etc.), or with a contribution to the consumption of these products.
- •Subject with tumor pathology, inflammatory, moderate to severe kidney failure, malabsorption syndrome,
- •Subject being under drug treatment or dietary supplement that may influence the results of kinetics: treatments that may affect gastric emptying, intestinal absorption (smectite-based intestinal dressings, etc.), insulin and blood sugar, Oral nutritional supplements (NOC), proton pump inhibitors (PPIs), corticosteroids, nonsteroidal anti-inflammatory drugs, antibiotics for less than a month,
- •Subject with diabetes or dyslipidemia,
- •Subject with a heavy medical or surgical history that may pose a risk to the volunteer under the protocol,
- •Subject who has undergone surgery that may interfere with the objectives of the study (at the discretion of the investigating physician) within 3 months preceding the study,
- •Person refusing to be registered on the National File of Healthy Volunteers of the Ministry of Health,
- •Major subject under trusteeship or with limited rights,
- •Subject not affiliated with social security,
- •Subject during the exclusion period of a previous study (after verification in the Biomedical Research Volunteers File).
结局指标
主要结局
Changes in the plasma concentrations of leucinemia
时间窗: 360 minutes after ingestion
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 360 minutes after the consumption of one of the 6 test periods.
次要结局
- Changes in the plasma concentrations of the others amino acids(360 minutes after ingestion)
- Changes of Blood sugar levels(360 minutes after ingestion)
- Changes of insulin levels(360 minutes after ingestion)
- Changes lipid profile(360 minutes after ingestion)
- Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)(240 minutes after ingestion)
- Areas under curves(360 minutes after ingestion)
研究者
Adeline BLOT
Clinical Research Associate
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement