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NCT05748080
The Apple Study: Two Apples a Day, Keep the Doctor Away?
Conditions: Microbial Colonization, Enzyme Overdose
Sex: Female
Ages: 50 Years – 64 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 12
Sponsor: Maastricht University Medical Center
Summary
The goal of this clinical trial is to learn about the gut microbiome in healthy postmenopausal women aged 50-64.
The main questions it aims to answer are:Investigate whether the activity of the bacterial enzyme β-glucuronidase and the abundance of β-glucuronidase-producing bacteria could be decreased by ingestion of 2 apples a day for a period of 6 weeksExamine changes in gut microbiota composition, diversity, and functional capacityExamine feasibility of eating 2 apples a day for a period of 6 weeksParticipants will eat 2 apples a day for a period of 6 weeks.Six weeks includes the period from the start of the study and gathering of baseline characteristics/questionnaires till the finish.
Eligibility Criteria
Inclusion Criteria:Age 50-64Postmenopausal womenRecent negative breast cancer screening (< 6 months)Exclusion Criteria:The regular consumption of one ore more apples a dayPrevious gastrointestinal surgery (excl.
appendix surgery)Any type of cancer in history, except for basal cell carcinoma (BCC)Inflammatory bowel diseaseMammography older than 6 monthsAntibiotic use within three months before fecal samplingPhysically or mentally incapable or incompetent to sign informed consentKnown apple allergy or complaints matching with apple allergyLess good dental state
Source: ClinicalTrials.gov (NCT05748080). StuddyBuddy aggregates publicly available trial information.