NCT06404749终止不适用
Fungal Fiber for Gut Health
Future Biome SA1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2024年5月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- GastroIntestinal Quality of Life Index
研究概览
简要总结
This study compares effects of plant based fiber vs fungi based fiber on clinical outcomes related to gut function (immunity, emotions, stress) and explores the role of gut microbiome structure and function on individual responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
data analysts
入排标准
- 年龄范围
- 38 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Provision of a signed and dated informed consent form
- •Declared willingness to comply with all study procedures and availability during the study.
- •Female, >37 years, ≤48 years
- •Healthy volunteers who have experienced at least one of the following Gastrointestinal symptoms in the last week: abdominal pain, full stomach, bloating, accidental leakage of intestinal gas, loud belching, bowel movements more frequent than usual, discomfort when eating, with a GIQLI score <121
- •Fiber intake <20g/day according to R24
- •18.5 ≤ BMI ≤ 29.9
- •Volunteers permanently living in the Buenos Aires Metropolitan Area for at least 6 months prior to the intervention.
- •Ability to take oral capsules and willingness to comply with intervention regimen of the study.
- •Agreement to comply with lifestyle considerations during the study.
排除标准
- •History of chronic immune, metabolic or gastrointestinal diseases.
- •History of gastrointestinal surgery.
- •Acute illness within one week prior to screening.
- •Treatment with oral or systemic antibiotics within 3 months prior to screening.
- •Hospitalization within 3 months prior to screening.
- •Consumption of laxatives or antidiarrheals, antispasmodic agents, antacids, anti-inflammatories within three days prior to screening.
- •Current intake of fiber or prebiotics as a supplement, or probiotics as a supplement.
- •Vegan, vegetarian or on a special diet.
- •Pregnancy or breastfeeding.
- •Menopause (absence of menstruation for 12 consecutive months) or postmenopause.
- •Known allergic reactions to components of the study interventions: inulin, beta-glucan, mushrooms, magnesium stearate, microcrystalline cellulose, hydroxypropylmethylcellulose.
- •Treatment with another investigational drug or other intervention in the last 6 months.
- •Receives pharmacological intervention for the treatment of a disease
- •Any disorder that, in the opinion of the investigator, could jeopardize safety of the participant.
研究组 & 干预措施
FB01
Experimental
fungal fiber, 150 mg/day, oral capsules, 2 weeks
干预措施: fungal fiber (Dietary Supplement)
inulin
Active Comparator
inulin, 3 g/day, oral capsules, 2 weeks
干预措施: inulin (Dietary Supplement)
结局指标
主要结局
GastroIntestinal Quality of Life Index
时间窗: From enrollment to the end of treatment at 6 weeks
GastroIntestinal Quality of Life Index (GIQLI), self assessed questionnaire, minimum score 0 (low quality), maximum score 144 (high quality)
次要结局
- Bristol(From the enrollment to the end of treatment at 6 weeks)
- Wisconsin Upper Respiratory Symptom Survey(From enrollment to the end of treatment at 6 weeks)
- Positive and Negative Affect Schedule(From enrollment to the end of treatment at 6 weeks)
- basal cortisol(From enrollment to the end of treatment at 6 weeks)
- hs-CRP(From enrollment to the end of treatment at 6 weeks)
- Short Chain Fatty Acids(From enrollment to the end of treatment at 6 weeks)
- Work Productivity and Activity Impairment(From enrollment to the end of treatment at 6 weeks)
- calprotectin(From enrollment to the end of treatment at 6 weeks)
研究者
研究点 (1)
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