Impact of a Wheat-based Fermented Beverage on Microbiota and Metabolic Health in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Gut microbiota
研究概览
简要总结
The proposed study aims to evaluate the impact on intestinal and oral microbiota composition and the metabolic effects of the daily consumption of a wheat-based fermented beverage, developed under the collaborative WHEATBIOME project, over a 4-week intervention period in healthy adults.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) between 18.5 and 24.9 kg/m²
- •Healthy status
- •Willingness to consume a fermented wheat-based beverage daily for 4 weeks
- •Capacity and willingness to provide written informed consent
排除标准
- •Use of antibiotics and/or probiotics in the 12 weeks prior to the study
- •Weight variation >10% within the last 3 months
- •Participation in any clinical study or trial within the previous 12 months
- •Diagnosed medical conditions, including: diabetes, liver disease (e.g., cirrhosis), pancreatitis or other malabsorption syndromes, gastrointestinal disorders (e.g., inflammatory bowel disease, celiac disease), history of weight-loss surgery (e.g., bariatric surgery), chronic respiratory, neurological, psychiatric, musculoskeletal, or other systemic conditions, eating disorders
- •Diagnosed food allergies or intolerances
- •Pregnancy or breastfeeding
研究组 & 干预措施
Intervention
Wheat-based fermented beverage (developed under the WHEATBIOME project)
干预措施: Wheat-based fermented beverage (Other)
结局指标
主要结局
Gut microbiota
时间窗: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Changes in gut microbiota from baseline. Microbial DNA will be extracted from faecal samples and sequenced by shotgun metagenomics. All the identified bacterial phyla, genus and species will be expressed in percentage.
Oral microbiota
时间窗: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Changes in oral microbiota from baseline. Microbial DNA will be extracted from buccal swabs and sequenced by shotgun metagenomics. All the identified bacterial phyla, genus and species will be expressed in percentage.
Fasting blood glucose
时间窗: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Changes in fasting blood glucose levels (mg/dL) levels from baseline.
Insulin
时间窗: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Changes in insulin levels (μU/mL) levels from baseline.
Total cholesterol
时间窗: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Changes in total cholesterol levels (mg/dL) from baseline.
LDL cholesterol
时间窗: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Changes in low-density lipoprotein (LDL) cholesterol (mg/dL) levels from baseline.
Triacylglycerides
时间窗: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Changes in triacylglycerides (mg/dL) levels from baseline.
Exhaled breath gas profile
时间窗: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Changes in exhaled methane and hydrogen represented in parts per million (ppm) from baseline.
次要结局
- Weight(At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks))
- Body fat mass(At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks))
- Gastrointestinal quality of life(At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks))
- Interleukin-6(At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks))
- Tumor Necrosis Factor-alpha(At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks))