NCT07096739已完成不适用
Tolerance and Acceptance of a High Protein Nutrition Shake in Individuals Treated With the GLP-1 Receptor Agonist Semaglutide: a Single Arm, Open Label Study
Kate Farms Inc1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Composite GI symptoms score (CSS)
研究概览
简要总结
Determine if consuming a high protein nutrition shake reduces gastrointestinal symptoms associated with semaglutide injections.
详细描述
This study investigates the tolerability of a shake specifically designed to reduce GI side effects in individuals being treated with the GLP-1 agonist semaglutide. The study uses a single-arm, open label design where subjects will consume the study product daily for 1 week. Participants will record GI symptoms over the past 24h on 3 days during the week prior to the intervention, and on days 3, 5 and 7 during the intervention
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy individuals aged 18-75 years, inclusive
- •BMI >27.0kg/m²
- •Taking semaglutide injections (Ozempic or Wegovy) as prescribed (eg. weekly), for at least 4 weeks prior to screening
- •Ability to understand the study procedures and willing to provide informed consent to participate in the study
- •Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP
- •Subjects must have an active e-mail address, daily access to an electronic device (e.g. computer, laptop, tablet, smart phone) and internet, and understand how to complete the daily electronic diary daily
排除标准
- •Failure to meet any one of the inclusion criteria
- •Use of a compounded GLP-1 agonist
- •Reported history of metabolic (including type 1 and type 2 diabetes mellitus), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, psychiatric disorders, or any other medical conditions that, in the judgment of the Principal Investigator, increase the risk to the subject or others or may affect results
- •Hospital admission for major trauma, or major medical or surgical event, as judged by the Principal Investigator, within 6 months of screening
- •Use of medications such as, but not limited to, hypoglycemic agents, systemic steroids, antipsychotics, or any others that increase the risk to the subject or others or may affect results, as judged by the Principal Investigator
- •Known intolerance, sensitivity, or allergy to any ingredients in the study test products
- •Self-reported pregnancy or breastfeeding or less than 6 weeks postpartum
- •Long term treatment with another investigational drug or other intervention within the last 30 days
- •Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk
结局指标
主要结局
Composite GI symptoms score (CSS)
时间窗: 7 days
Comparison of the composite GI symptom scores (CSS) recorded during the 7day intervention period with those recorded during the 3-day baseline period.
次要结局
未报告次要终点
研究者
研究点 (1)
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