A Post-launch Study in Spain Assessing Self-perceived Health Benefits and Gut Microbiota Following 2 Weeks Activia Kefir Consumption in Real-world Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 6
- 主要终点
- Gastrointestinal (GI)-wellbeing (single-item question)
研究概览
简要总结
The study aims at generating first real-world insights into how consumers perceive the benefits of consuming Activia Kefir on their digestive wellbeing, overall wellbeing, and to explore its potential effects on the gut microbiome.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged 18 years and older at the time of screening;
- •Willingness to consume Activia Kefir and complete the requested questionnaires;
- •Living in the designated locations in Spain, able to read and write in Spanish;
- •Have a personal electronic device compatible and connectable to internet (i.e., computer, laptop, smartphone) to fill the questionnaires;
- •Signed informed consent.
排除标准
- •People that currently participate in another study with (dairy) investigational or marketed products;
- •Severely immunocompromised individuals (e.g., post-transplant, advanced HIV/AIDS, undergoing chemotherapy);
- •Individuals with known allergies or intolerances to product ingredients. For lactose maldigestion, kefir may improve tolerance, so individuals who are aware of their condition and still wish to participate can be included.
研究组 & 干预措施
Consumers of Activia Kefir
干预措施: Commercialized dairy product consumption and stool samples collection (Other)
结局指标
主要结局
Gastrointestinal (GI)-wellbeing (single-item question)
时间窗: After 2 weeks of study product consumption
Difference between after consumption and baseline
Stool consistency (Bristol stool scale, single-item)
时间窗: After 2 weeks of study product consumption
Difference between after consumption and baseline
Stool frequency (number of stools/week, single-item)
时间窗: After 2 weeks of study product consumption
Difference between after consumption and baseline
Digestive symptoms frequency questionnaire (DSFQ, frequency of 4 symptoms: abdominal pain/discomfort, bloating, flatulence, borborygmi)
时间窗: After 2 weeks of study product consumption
Difference between after consumption and baseline
次要结局
- PROMIS global health questionnaire (10-item, includes questions about emotional state fatigue, pain, general health, quality of life, physical health, mental health, satisfaction social activities, usual activities, and everyday physical activities)(After 2 weeks of study product consumption)
- WHO wellbeing questionnaire (5-items, includes questions about cheerful/good spirits, calm/relaxed, active/vigorous, feeling fresh/rested, daily life with things that interest me)(After 2 weeks of study product consumption)
- Perceived resilience (using the 2-item Connor-Davidson Resilience Scale (CD-RISC)-2)(After 2 weeks of study product consumption)