Metabolic Signatures Resulting From Acute (Postprandial) Ingestion of Yoghurt or Milk in Humans: Effect of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Metabolomics: discovery of novel biomarkers of acute dairy intake (milk and yogurt)
研究概览
简要总结
Despite the fact that dairy products are greatly consumed, it remains today very difficult to determine with a classical blood biochemical test whether a person has ingested a fresh fermented dairy product or just milk, while their biological, metabolic and health impacts may be different.
The metabolic footprint left by the consumption of these products could be modified by the age of the consumer. Indeed, in the elderly, the processes of digestion, assimilation and metabolism are known to be altered /different compared to healthy adults. Thus, different metabolic signatures in the elderly could appear as the result of a less effective use and metabolism of the nutrients ingested. This could further also result in different or altered biological effects on dairy products.
详细描述
The two main objectives of this project are to:
- Determine precisely the plasma and urine metabolic signatures resulting from acute (postprandial) ingestion of yogurt or milk.
- Characterize the metabolic signature following the consumption of these dairy products in the elderly and compared with the signature of reference (adult).
- Understand the mechanisms and metabolic pathways involved if discriminating metabolites between age are detected..
The clinical study is open, monocentric, controlled and randomized, in a cross experimental design.
The study is not performed in a double blind way. However, the measure bias will be limited because of the standardized and objective characteristic of the main criteria. Moreover, biological samples will be analyzed by the same partners of the project. Each subject will be its own control, so that confusion factors related to individual variability will be eliminated.
A total of 28 volunteers (men) will participate in the study: 14 adults and 14 old people (>65 yrs-old). After 3 weeks of controlled diet (without consumption of dairy products) the volunteers will ingest 600g of milk or yogurt. After 1 week of wash-out, the other product will be consumed. Blood and urine will be collected during the postprandial period.
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
- None
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •no pathology and no medical treatment
- •BMI >=21 and <=30 kg/m²
- •normal biological status
- •no dislike for diary intake
排除标准
- •no pathology and no medical treatment (no antibiotics in the last 3 months)
- •consumption of nutritional supplements several times at week
研究组 & 干预措施
Milk acute intake
14 adult and 14 elderly volunteers will consume 600mL of milk. Blood (11 sampling points) and urine samples (3 collection points) will be collected before the ingestion and during the postprandial period (6h).
干预措施: Acute milk intake (Other)
Yogurt acute intake
14 adult and 14 elderly volunteers will consume 600mL of yogurt. Blood (11 sampling points) and urine samples (3 collection points) will be collected before the ingestion and during the postprandial period (6h).
干预措施: Acute Yogurt intake (Other)
结局指标
主要结局
Metabolomics: discovery of novel biomarkers of acute dairy intake (milk and yogurt)
时间窗: Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
Analysis of the urine and plasma metabolome
次要结局
- glucose homeostasis markers(Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt))
- Inflammation markers(Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt))
- lipid homeostasis markers(Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt))
研究者
Sergio Polakof
PhD
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement