Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Metabolic Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Efficacy of VIOME Precision Nutrition Program (VPNP)
研究概览
简要总结
US residents who have obesity and 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 placebo 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 and/or dietary recommendations towards improving the symptoms associated with metabolic wellness. 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.
- •Fasting insulin level >=15 uIU/mL or fasting glucose >= 100 mg/dL within the last 3 months, verified from medical records
排除标准
- •Unwilling to change current diet
- •Unwilling to go to Quest
- •Prior use of Viome products or services
- •Antibiotic use in the previous 4 weeks
- •Women who are pregnant (current or planned in the next 4 months), or breastfeeding
- •< 90 days postpartum
- •Active infection
- •Unable or unwilling to use Viome's App on an iPhone or Android smartphone
- •Significant diet or lifestyle changes in the previous 1 month
- •IBD diagnosis
- •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
- •Current (or previous) use of medications that increase insulin (sulfonylureas, such as glimepiride, glipizide, glyburide, etc.)
- •Current (or previous) use of exogenous insulin (such as Tresiba, Lantus, Toujeo, Levemir, Humalog, Novolog, Apidra, Fiasp, etc.)
- •Prescribed any drug(s) that may interact with the supplement formulations
- •Have any medical condition or allergy that may interact with, or prevents the healthy consumption of the supplements such as:
- •Pregnancy Breastfeeding Minors GERD Gastric Ulcers Ulcerative Colitis Crohn's Disease Kidney Impairment (kidney cysts, kidney disease) Liver Condition (gallstones, cholecystitis, cirrhosis, hepatitis, hepatitis a, hepatitis b, hepatitis c, NAFLD/NASH, etc) HIV SIBO CuminAllergy GymnemaAllergy BacopaAllergy CitrusAIlergy LamiaceaeAllergy SageAllergy YeastAllergy MulberryAllergy ChicoryAllergy
- •Allergies to any study-specific supplement ingredients
- •Currently on a specific diet:
- •FODMAP KETO PALEO
- •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
Efficacy of VIOME Precision Nutrition Program (VPNP)
时间窗: ~4 months
Number of participants that show an improvement in metabolic health compared to baseline survey assessment.
Efficacy of VIOME's designed condition based supplements (VCS)
时间窗: ~4months
Number of participants that show an improvement in metabolic health compared to baseline survey assessment.
次要结局
未报告次要终点