- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT06954675
Comparaison des changements de microbiome chez des adultes en bonne santé après la consommation d'esters de cétone (BREAK)
Réponses bactériennes aux altérations entériques après des cétones
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sidharth S Madhavan, PhD
- Numéro de téléphone: 248-797-1025
- E-mail: sidharth.madhavan@ucsf.edu
Sauvegarde des contacts de l'étude
- Nom: John C Newman, MD, PhD
- Numéro de téléphone: 415-502-5134
- E-mail: Newman@ucsf.edu
Lieux d'étude
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California
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San Francisco, California, États-Unis, 94158
- Recrutement
- UCSF Wayne and Gladys Valley Center for Vision
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Contact:
- Sidharth S Madhavan, PhD
- Numéro de téléphone: 248-797-1025
- E-mail: sidharth.madhavan@ucsf.edu
-
Chercheur principal:
- John C Newman, MD, PhD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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) |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Longitudinal Change in Microbiome Composition
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Acute Tolerability Symptoms related to Product Ingestion
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: John C Newman, MD, PhD, University of California, San Francisco
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 25-43835
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
This is a pilot study that will only be used to inform future trial design, no IPD will be shared externally.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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