Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Determine whether oral BHB supplementation is safe and tolerable
研究概览
简要总结
The aim of this study is to assess the feasibility of beta-hydroxybutyrate (BHB) supplementation in individuals who are undergoing a standard-of-care colonoscopy or flexible sigmoidoscopy.
详细描述
The aim of this study is to assess the feasibility of β-hydroxybutyrate (BHB) supplementation in individuals who are undergoing a standard-of-care colonoscopy or flexible sigmoidoscopy in order to determine whether BHB supplementation is safe and tolerable. Additionally, this study will determine whether BHB supplementations increases serum BHB levels, and leads to transcription and protein expression changes in the colonic mucosa. BHB supplementation will be performed through oral administration of HVMN Ketone-IQ, a commercially available BHB supplement, with an active ingredient of R-1,3-Butanediol, which gets converted to BHB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Age of 18 years or older
- •Scheduled for a colonoscopy or flexible sigmoidoscopy as part of the patient's standard care
- •Can provide informed consent
排除标准
- •Subject is pregnant, a prisoner, or is under 18 years of age
- •Patient is not able to undergo colonoscopy or flexible sigmoidoscopy
- •Prior total proctocolectomy
- •History of inflammatory bowel disease
- •History of diabetes mellitus and are currently on medical diabetes therapy
- •History of chronic kidney disease with an eGFR < 60 mL/min/1.73m2
- •Cancer diagnosis where the subject is receiving active therapy
- •Use of either a ketogenic diet or intermittent fasting (defined as a fasting period of 16 hours or more per day that is not associated with a medical procedure) during the 4 weeks prior to enrollment
研究组 & 干预措施
BHB supplementation
Study participants will be taking 35mL of HVMN Ketone-IQ by mouth three times daily, with each dose containing 10 grams of R-1,3-Butanediol, for a total of 4 weeks.
干预措施: R-1,3-Butanediol (Dietary Supplement)
结局指标
主要结局
Determine whether oral BHB supplementation is safe and tolerable
时间窗: Through study completion, which will be approximately 2 years
Assessment of patient tolerance of BHB supplements through weekly monitoring of side effects and/or intolerances and patient compliance. We will monitor the percentage of individuals who continue through Visit 2, and the percentage continuing through Visit 3, as well as the compliance with taking the BHB supplement.
次要结局
- Determine whether oral BHB supplementations increases serum BHB levels(Through study completion, which will be approximately 2 years)
- Investigate whether oral BHB supplementation leads to transcription and protein expression changes in the colonic mucosa(Through study completion, which will be approximately 2 years)