Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Mental Health Conditions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Reduced Perceived Stress Scale Score
研究概览
简要总结
US residents who have mental health issues sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of three arms. This study is direct to participant and will NOT utilize clinical sites.
详细描述
Participants who meet the eligibility criteria are randomized into any of the three arms including: the control arm, VIOME's condition-based supplements (VCS) arm or the VIOME Precision Nutrition Program (VPNP) arm.
Placebo, Viome-designed condition-based supplements and Viome's Precision Nutrition Program include supplements, may include dietary recommendations towards improving the symptoms associated with mental health. The trial will last approximately 4 months for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Once enrolled, participants are randomized into one of the three arms. The coded supplements with blinded labels are shipped to the participants. The participants are not aware of which group they are randomized into.
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resident of the United States
- •Females and males ages 25-75 (inclusive)
- •Able to speak and read English
- •No unexplained weight loss, fevers, anemia, or blood in stool
- •Willing and able to follow the trial instructions, as described in the recruitment letter
- •Signed and dated informed consent prior to any trial-specific procedures.
- •PHQ9 score of 5-24 (inclusive)
排除标准
- •Unwilling to change their current diet
- •Prior use of Viome products or services
- •Antibiotic use in the previous 4 weeks
- •Pregnancy (current or planned in the next 4 months)
- •< 90 days postpartum
- •Breast feeding
- •Active infection
- •Unable or unwilling to use Viome's App on an iPhone or Android smartphone
- •Significant diet or lifestyle change in the previous 1 month
- •IBD diagnosis -Major psychiatric/DSM-4 disease diagnosis (e.g. Schizophrenia, Bipolar disorder, Post- traumatic Stress Disorder, Obsessive Compulsive disorder)
- •Use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial
- •Cancer therapy within the previous 1 year
- •Major surgery in the last 6 months or planned in the next 4 months
- •Allergies to any supplement ingredients listed in the screening survey
- •Currently on a specific diet: FODMAP, KETO, PALEO
- •Answered yes to the question, "In the past few weeks, have you wished you were dead or had thoughts about killing yourself?"
- •Gastrointestinal disease including:
- •GI surgery except:
- •Appendectomy and benign polypectomy
- •Esophagitis
- •Celiac disease
- •GI malignancy or obstruction
- •Peptic Ulcer Disease
- •Duodenal or gastric ulcer disease
结局指标
主要结局
Reduced Perceived Stress Scale Score
时间窗: ~4 months
Reduced Perceived Stress Scale score for both VCS and VPNP groups compared to baseline scores.
Increased Quality of Life Score
时间窗: ~4 months
Increased quality of life score for both VCS and VPNP groups compared to baseline scores.
Reduced PHQ-9 Score
时间窗: ~4 months
Reduced PHQ-9 score for both VCS and VPNP groups compared to baseline scores.
Reduced GAD-7 Score
时间窗: ~4 months
Reduced GAD-7 score for both VCS and VPNP groups compared to baseline scores.
Correlation between microbial changes and clinical outcomes
时间窗: ~4 months
Correlation between microbial changes on VCS or VPNP with clinical outcomes.
次要结局
未报告次要终点