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Not Yet Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05748080). StuddyBuddy aggregates publicly available trial information.