NCT04707989已完成不适用
A Randomized, Placebo Controlled, Study to Evaluate the Tolerance and Safety of a Ketone- Promoting Food Ingredient in Healthy Men and Women
BHB Therapeutics, Ireland LTD2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年12月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Long-term tolerance of ketone promoting food ingredient #1
研究概览
简要总结
The objective of this study is to capture information on tolerance and safety of a ketone-promoting food ingredient in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is generally healthy male or female, 18-65 years of age.
- •Subject has a BMI 18.5-34.9 kg/m2 (inclusive).
- •Subject is willing and able to comply with all study procedures including consumption of breakfast and lunch daily, maintenance of habitual dietary intake, exercise and medication and supplement use, blood draws and the following prior to test visits: fasting (>10 h; water only), no alcohol (>10 h), no cannabis products (>10 h) and no exercise (>10 h).
- •Subject has internet access via computer, phone, or other device and is able to maintain internet access throughout the trial in order to complete online daily questionnaires.
- •Subject has no health conditions that would prevent him from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results.
- •Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.
排除标准
- •Subject has an abnormal laboratory test result(s) of clinical importance at screening, at the discretion of the Clinical Investigator.
- •Subject has a history or presence of uncontrolled and/or clinically important pulmonary, cardiac, hepatic, renal, endocrine (including type 1 and 2 diabetes), hematologic, immunologic, neurologic, psychiatric or biliary disorders at the discretion of the Investigator.
- •Subject has a clinically important gastrointestinal (GI) condition that would potentially interfere with the evaluation of the study beverage.
- •Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- •Subject is a current user of tobacco, smoking products (including, but not limited to cigarettes, cigars, chewing tobacco, e-cigarettes), and nicotine products (e.g., nicotine gum and/or nicotine patches) within 6 months of screening at the equivalent of >5 cigarettes per day.
- •Subject has a history of or strong potential for alcohol or substance abuse.
- •Subject is consistently using prescriptive or over-the counter medications where alcohol is a contraindication at the discretion of the Investigator.
- •Subject has a known allergy, intolerance, or sensitivity to any of the ingredients in the study beverages.
- •Subject has uncontrolled hypertension as defined by the blood pressure measured at screening.
- •Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
- •Subject has experienced any major trauma or any other surgical event within three months of screening.
- •Subject has recently used antibiotics.
- •Subject has extreme dietary habits or has used weight-loss medications or programs within 30 days of screening.
- •Subject has used medications known to influence gastrointestinal function within 30 days of screening.
- •Subject consistently uses anti-inflammatory medications (>5 times/week) within 30 days of screening.
- •Subject has used ketone supplements within 30 days of screening.
- •Subject has unstable use of thyroid, antihypertensive, antidepressant, or statin medications within 6 months of screening.
- •Individual has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
- •Subject works nights or shifts that means it is not possible to maintain a consistent meal schedule during the study.
结局指标
主要结局
Long-term tolerance of ketone promoting food ingredient #1
时间窗: Day From baseline to Day 28
Difference between experimental arm (ketone promoting food ingredient #1) vs placebo in composite score of tolerance, assessed by twice daily tolerance questionnaires completed at home. Subjects complete a tolerance questionnaire twice daily, to assess the presence of 10 symptoms before and 4-6h after consuming the study beverage. Questionnaire ranks severity (None, mild, moderate, severe) and incidence (usually, somewhat more than usual, much more than usual). Answers are assigned a numerical value, where higher score is a greater severity and incidence of symptoms. The difference is calculated between the pre- and post- beverage questionnaire for a daily score. Daily scores for the duration of the study are added together to give a single composite score for the whole study period.
次要结局
- Subjective Arousal after ketone promoting food ingredient #1(From baseline to Day 28)
- Acute tolerance of ketone promoting food ingredient #1(Days 0, 7 and 14)
- Safety Blood Profile(From baseline to Day 28)
研究者
研究点 (2)
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