Fava Bean Protein and Amino Acid Bioavailability in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Ileal digestibility of protein and amino acids
研究概览
简要总结
The goal of the project is to determine the ileal amino acid digestibility of Favabean in healthy subjects equipped with naso-ileal tube. For this purpose, Favabean will be intrinsically labelled with 15N using 15N fertilizer. This procedure will be realized in Finland and the labelled material will be sent to the Unit PNCA.
详细描述
The objective is to determine the nutritional quality of protein from favabean in healthy humans, especially in terms of amino acid digestibility. Ileal digestibility is determined in ileal digesta collected postprandially with a naso-ileal tube. The favabeans are intrinsically labelled in 15N in order to track dietary nitrogen and amino acids in the samples.
Ethical and regulatory aspects:
The protocole was submitted to the Ethical Committee for approval and to the French Agency of Drugs and Health for administrative authorization. The personal data management will be in accordance with the regulation on personal data protection ( " regulation n° 2018-493 du 20 juin 2018").
Meal:
The meal will consist in 250 g of cooked and peeled favabean, to provide 20 g protein. Sensory tests will be realized to optimize the organoleptic properties of the meal. 15N labelled bean will be boiled in water with salt. On the morning of the experiment, the portion of fava bean will be warmed up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •18<BMI<30
- •Good health (WHO=0)
- •For woman: use of birth control
排除标准
- •allergy against legumes
- •allergy against latex
- •pregnant women
- •Positive serology for AgHBS, AcHbc, HCV, HIV
- •Positive PCR test for SARS-Cov2
- •Excessive alcohool consumption
- •Hypertension, diabetes, digestive, hepatic or renal diseases, cardiac disease
- •Exercice>7h/week
- •Blood donation within 3 months before the study
- •Participation to another clinical study within 3 months before the study
研究组 & 干预措施
Fava bean
The intervention consists in a test meal containing 250 g of cooked and peeled favabean, to provide 20 g protein. Fava bean are intrinsically labelled with 15N.
干预措施: Test meal with 15N labeled favabean (Dietary Supplement)
结局指标
主要结局
Ileal digestibility of protein and amino acids
时间窗: -30 minutes to 8 hours after the test meal
The measurement of nitrogen (mmol) and 15N enrichment (atom %) in ileal samples allow to determine the amount of dietary nitrogen in the lumen. The measurement of amino acid concentration (mmol) and their individual 15N enrichment (atom %) allow the determination of dietary amino acids remaining in the lumen. Dietary amino acids and dietary nitrogen that are recovered in the ileal samples are then considered as non absorbed.
次要结局
- Net Postprandial Protein Utilization (NPPU)(0 to 8 hours after the test meal)
- gut microbiota in response to the ingestion of 15N fava bean(0 to 2 days after the test meal)
- Plasma insulin in blood in response to the ingestion of 15N fava bean(0 to 8 hours after the test meal)
- Starch digestibility in response to the ingestion of fava bean(-30 minutes to 8 hours after the test meal)
- Nitrogen metabolites in blood in response to the ingestion of 15N fava bean(0 to 8 hours after the test meal)
- Plasma glucose in blood in response to the ingestion of 15N fava bean(0 to 8 hours after the test meal)
研究者
Robert Benamouzig
Professor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement