The Effect of Daily Consumption of a Fruit Juice on Acute Satiety Response and Gut Microbiota Changes in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes in the iAUC (pmol/L*min) for ghrelin
研究概览
简要总结
The "cLabel+ Innovative natural, nutritious and consumer-oriented clean label food" is a research and technological development project centered on responding to the challenges facing the food industry. It is focused on the concept of "clean label", which emerges as one of the major current trends in the sector, given the growing number of consumers who are increasingly aware and eager for information, who are looking for alternative, more transparent and natural food products.
Thus, one of the aims of the cLabel+ project is to research the macronutrients and phenolic compounds present in food matrices and achieve a clean label positioning for the final products developed. This single group assignment clinical trial aims to evaluate the effect of daily consumption of a fruit juice, developed as part of the collaborative project cLabel+, on gut microbiota composition and diversity in healthy adults. It is also intended to study the acute metabolic effect, namely in terms of appetite control, and lipid and glucose metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women
- •Adults (age ≥ 18 years)
- •Filling informed consent
排除标准
- •Obesity (body mass index ≥ 30.0 kg/m2).
- •Daily consumption of fruit juices in the month prior to the start of the study.
- •Individuals with diagnosed food allergies or intolerances to the components being tested.
- •Use of pro/prebiotics or fibre as a dietary supplement or any food/molecule that modifies intestinal transit time 6 weeks before recruitment.
- •Use of laxatives 6 weeks before recruitment.
- •Recent weight loss or weight gain of more than 10% in the last 3 months.
- •Adherence to restrictive weight loss diets or specific dietary pattern (e.g., palaeolithic diet, Atkins, flexitarian, ketogenic, vegan).
- •Diagnosis of gastrointestinal pathology, hormonal or thyroid pathology, autoimmune diseases, chronic use of corticosteroids, psychiatric disease, or diabetes mellitus.
- •Having taken antibiotics within the 12 weeks prior to beginning the study.
- •Excessive consumption of alcoholic beverages (>14 and >8 units/week for men and women, respectively).
- •Pregnant or breastfeeding.
- •Participation in another clinical trial within the past 3 months that the Principal Investigator believes may compromise the results of the trial (e.g., clinical trial with an effect on the composition and diversity of the gut microbiota).
结局指标
主要结局
Changes in the iAUC (pmol/L*min) for ghrelin
时间窗: 14 days
Ghrelin will be measured in fasting and every 30 minutes up to 3 hours. The iAUC (pmol/L\*min) for ghrelin will be calculated based on the concentration curve following consumption of the fruit juice.
Changes in gut microbiota diversity
时间窗: 14 days
Difference in gut microbiota Shannon index, from baseline to the end of intervention.
Changes in gut microbiota characterization
时间窗: 14 days
Differences in gut microbiota taxonomic characterization from baseline to the end of the intervention.
Changes in the iAUC (pmol/L*min) for glucagon-like peptide-1 (GLP-1)
时间窗: 14 days
GLP-1 will be measured in fasting and every 30 minutes up to 3 hours. The iAUC (pmol/L\*min) for GLP-1 will be calculated based on the concentration curve following consumption of the fruit juice.
Changes in the iAUC (pmol/L*min) for peptide YY (PYY)
时间窗: 14 days
PYY will be measured in fasting and every 30 minutes up to 3 hours. The iAUC (pmol/L\*min) for PYY will be calculated based on the concentration curve following consumption of the fruit juice.
次要结局
- Changes in faecal LPS(14 days)
- Changes in fasting glucose(14 days)
- Changes in fasting insulin(14 days)
- Changes in HOMA-IR(14 days)
- Changes in total cholesterol(14 days)
- Changes in LDL cholesterol(14 days)
- Changes in HDL cholesterol(14 days)
- Changes in expired breath H2(14 days)
- Changes in faecal calprotectin(14 days)
- Changes in triacylglycerols(14 days)
- Changes in high sensitivity PCR(14 days)
- Changes in expired breath CH4(14 days)
- Changes in faecal butyrate(14 days)
- Changes in faecal alkaline phosphatase (ALP)(14 days)
- Changes in faecal acetate(14 days)