Protein Quality of Fava Bean Meat Analogue and Honey Chlorella Ingested as Mixed Meals in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 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 protein quality of alternative protein sources, honey chlorella and Faba bean, ingested as mixed meals in healthy subjects equipped with naso-ileal tube. For this purpose, Chlorella and Faba bean are intrinsically labelled with 15N. Faba bean is processed to produce a meat analogue. Chlorella is introduced in a drink. The protein quality is determined by following the digestive and metabolic fate of 15N during a 8h postprandial investigation.
详细描述
The objective is to determine the nutritional quality of protein from honey chlorella and faba bean meat analogue in healthy humans, especially in terms of protein and amino acid digestibility as well as nitrogen retention. Ileal digestibility is determined in ileal digesta collected postprandially with a naso-ileal tube. The protein sources are intrinsically labelled in 15N in order to track dietary nitrogen and amino acids in the samples.
Ethical and regulatory aspects:
The protocol has been approved to the Ethical Committee and authorized the French Agency of Drugs and Health. 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 either a drink containing 40 g of honey chlorella or a mixed meal containiong 80 g of meat analogue, to provide 20 g protein. Sensory tests will be realized to optimize the organoleptic properties of the meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •food allergy
- •allergy against latex
- •pregnant women
- •Positive serology for AgHBS, AcHbc, HCV, HIV
- •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
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. Dietary nitrogen that is recovered in the ileal samples are then considered as non absorbed.
Net Postprandial Protein Utilization (NPPU)
时间窗: 0 to 8 hours after the test meal
The measurement of urea (mmol) and 15N enrichment of urea (atom %) allow to determine the amount of dietary N that was transferred to urea, thus accounting for metabolic losses. Metabolic losses of dietary N, together with digestive losses of dietary N, are not retained in the body.
Ileal digestibility of amino acids
时间窗: -30 minutes to 8 hours after the test meal
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 that are recovered in the ileal samples are then considered as non absorbed.
次要结局
- Peptide composition of ileal digesta(0-8 h 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)
- 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)
- Ileal microbiota(-0.5 h before the meal)
研究者
Robert Benamouzig
Professor in Gastroenterology
Assistance Publique - Hôpitaux de Paris