ケトンエステル消費後の健康な成人の微生物叢の変化の比較 (BREAK)
ケトン後の腸の変化に対する細菌反応
The goal of this observational study is to learn if a ketone ester can improve the content of the gut microbiome. The main questions it aims to answer are:
- Does a ketone ester reduce age-related signatures in the gut microbiome?
- What changes occur in the gut microbiome after consuming a ketone ester?
Participants will:
- Take a ketone ester every day for seven (7) days
- Collect and ship stool samples within seven (7) days before, during, and within seven (7) days after the study period
- Measure their ketone levels with a urine strip every day after having the drink
- Answer questions about their typical diet on a normal day
- Record their symptoms, if any arise
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Sidharth S Madhavan, PhD
- 電話番号:248-797-1025
- メール:sidharth.madhavan@ucsf.edu
研究連絡先のバックアップ
- 名前:John C Newman, MD, PhD
- 電話番号:415-502-5134
- メール:Newman@ucsf.edu
研究場所
-
-
California
-
San Francisco、California、アメリカ、94158
- 募集
- UCSF Wayne and Gladys Valley Center for Vision
-
コンタクト:
- Sidharth S Madhavan, PhD
- 電話番号:248-797-1025
- メール:sidharth.madhavan@ucsf.edu
-
主任研究者:
- John C Newman, MD, PhD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Subject is male or female, 18 to 40 years of age, inclusive, at Virtual Visit 1.
- Subject has a self-reported BMI of 18.5 to 39.9 kg/m2 (inclusive) at Virtual Visit 1.
- Subject is willing and able to comply with all study procedures including maintenance of habitual dietary intake, consumption of study product at specified intervals, written questionnaires including study log and beverage tolerability questionnaire (KETQ), habitual exercise and medication and supplement use.
- Subject has an email address and internet access via computer, phone, or other device, and is willing and able to maintain internet access throughout the trial to complete virtual visits via video conference.
- Subject has no health conditions that would prevent them from fulfilling the study requirements as judged by the Study Clinician on the basis of medical history.
- Subject understands the study procedures and signs forms providing informed consent to participate in the study.
Exclusion Criteria:
- Subject is unable to converse in English or Spanish
- Subject is unable to provide informed consent due to cognitive impairment or insufficient English or Spanish language comprehension
- Subject has been hospitalized within 30 days of Virtual Visit 1.
- Subject has a history or presence of uncontrolled and/or clinically active pulmonary, cardiac (e.g. >= New York Heart Association class III), hepatic, renal, endocrine (including type 1 diabetes), hematologic, immunologic, neurologic (e.g., Alzheimer's or Parkinson's diseases), psychiatric (including unstable depression and/or anxiety disorders) or biliary disorders. Stable chronic disease is not an exclusion criterion unless specified.
- Subject has a clinically important gastrointestinal condition that would potentially interfere with the evaluation of the study beverage [e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation, severe constipation (in the opinion of the Study Clinician), history of frequent diarrhea, history of surgery for weight loss, gastroparesis, systemic disease that might affect gut motility according to the Study Clinician, reflux requiring daily medication, history of gastrointestinal ulcers or bleeding, celiac disease, and/or clinically important lactose intolerance].
- Subject has a known allergy, intolerance, or sensitivity to any of the ingredients in the study product, including milk protein.
- Subject is undergoing treatment or active surveillance for cancer, or has been diagnosed with cancer in the prior two years, except for non-melanoma skin cancer.
- Subject has recently used antibiotics within 60 days of Virtual Visit 1.
- Subject has extreme dietary habits (e.g., intermittent fasting or time restricted eating, Atkins diet, vegan, very high protein/low carbohydrate or has used weight-loss medications (including over-the-counter medications and/or supplements) or programs within 30 days of Virtual Visit 1.
- Subject has used medications (over-the-counter or prescription) known to influence gastrointestinal function including, but not limited to, opioids, weight loss medications, antidiarrheals, and antispasmodics) within 30 days of Virtual Visit 1.
- Subject has used ketone supplements (ketone salts or esters, and medium chain triglycerides [MCT]) within 30 days of Virtual Visit 1.
- 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. The method of contraception must be recorded.
- Subject has a condition the Study Clinician believes would interfere with their 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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:基礎科学
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:25g Bis-octanoyl-(R)-1,3-butanediol (C8)
Participants will receive 25g of the ketone ester bis-octanoyl-(R)-1,3-butanediol (C8) daily. |
25g Bis-octanoyl-(R)-1,3-butanediol (C8) |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Longitudinal Change in Microbiome Composition
時間枠:From baseline sampling to final sampling, including intervention period, at 21 days
|
Microbiome composition will be defined as the following components: 1) alpha-diversity as calculated by Shannon Index; 2) beta-diversity; and 3) microbial community taxa and gene number. |
From baseline sampling to final sampling, including intervention period, at 21 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acute Tolerability Symptoms related to Product Ingestion
時間枠:From start to end of intervention at 7 days
|
Symptoms will be assessed daily using a standardized Beverage Tolerability Questionnaire (Stubbs et al. J Nutr Health Aging 2024). Symptoms are rated on a scale of mild, moderate, and severe with the following symptoms: 1) gas/flatulence; 2) nausea; 3) vomiting; 4) abdominal cramping; 5) stomach rumbling; 6) burping; 7) reflux/heartburn; 8) diarrhea; 9) headache; and 10) dizziness. |
From start to end of intervention at 7 days
|
協力者と研究者
捜査官
- 主任研究者:John C Newman, MD, PhD、University of California, San Francisco
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。