Activity Changes in Irritable Bowel Syndrome (IBS), Anxiety, and Depression Following the Use of Viome Precision Nutrition Program (VPNP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Disease activity changes anxiety
研究概览
简要总结
Viome costumers are consented and recruited for this study and complete the questionnaires upon enrollment. Any participant who previously self reported depression, anxiety, or Irritable Bowel Syndrome (IBS) qualify for this study.
All participants receive Viome's diet, supplement and recommendations.
详细描述
Participants receive Viome Precision Nutrition Program (VPNP) after completing the health assessment and questionnaire. VPNP consists of diet, supplement and recommendations based on results from their sample results and their self reported questionnaire.
After approximately 5 months, participants were given the same health assessment questionnaire.
The results and data collected before and after the VPNP are analyzed to find correlations and differences between the measurements taken at the beginning of the trial and again approximately 5 months after.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •PHQ-9 score 5 or above
- •GAD-7 score 5 or above
- •IBS ROME-IV score 125 or above
- •Females and males aged 18 years or older
- •Signed and dated informed consent prior to any trial-specific procedures are performed
- •Able to speak and read English
- •Willing and able to follow the trial instructions
- •Viome existing costumer
排除标准
- •Unable/unwilling to complete the provided questionnaires
研究组 & 干预措施
Intervention arm
All participants received the intervention in this trial (VPNP diet and supplement recommendations).
干预措施: VIOME Precision Nutrition Program (Dietary Supplement)
结局指标
主要结局
Disease activity changes anxiety
时间窗: ~5 months
Change of disease activity measurements in participants with self reported anxiety after they have received Viome Precision Nutrition Program (VPNP), which consists of dietary supplement recommendations from Viome using clinically validated questionnaires. For anxiety, General Anxiety Disorder 7 (GAD-7) was used, which is designed to assess the participants' health status during the previous 2 weeks.
Disease activity changes depression
时间窗: ~5 months
Change of disease activity measurements in participants with self reported depression after they have received Viome Precision Nutrition Program (VPNP), which consists of dietary supplement recommendations from Viome using clinically validated questionnaires. For depression, brief patient health questionnaire mood scale (PHQ-9) was used.
Disease activity changes for IBS
时间窗: ~5 months
Change of disease activity measurements in participants with self reported IBS after they have received Viome Precision Nutrition Program (VPNP), which consists of dietary supplement recommendations from Viome using clinically validated questionnaires. For IBS, Rome IV classification and criteria based on interpretation and self reporting of IBS, experience and symptoms were used to measure before and after VPNP for approximate duration of 5 months.
次要结局
未报告次要终点
研究者
Momchilo Vuyisich
Study Principal Investigator
Viome