The Apple Study: Two Apples a Day, Keep the Doctor Away?

NCT ID: NCT05748080

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-10-31

Brief 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 weeks
• Examine changes in gut microbiota composition, diversity, and functional capacity
• Examine feasibility of eating 2 apples a day for a period of 6 weeks

Participants 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.

Detailed Description

It is know that estrogen levels decrease after menopause. There are many different factors affecting these levels though; the gut microbiome has been identified as one of these. Not only the composition of the gut microbiota plays a role here, but also its activity is of special interest. The gut microbiota for instance produces the bacterial enzyme β-glucuronidase which has been shown to de-conjugate biliary excreted estrogens, leading to reactivation and reabsorption of estrogens into the bloodstream. It might be expected that this reabsorption results in elevated blood estrogen levels. Elevated levels of estrogen have been linked to not only development but also recurrence of breast cancer.

Apples are known for their pectin which has prebiotic properties and a potential decreasing effect on β-glucuronidase activity. In vitro studies and animal studies have already shown the β-glucuronidase decreasing impact of pectin. In humans this was never examined before.

This study aims to investigate whether it is possible to lower the activity of the bacterial enzyme β-glucuronidase and the abundance of β-glucuronidase-producing bacteria by a simple dietary intervention. This dietary intervention consists of the ingestion of two whole apples a day, one in the morning and one in the evening, during the period of 6 weeks. Thereby this study aims to examine the feasibility of this intervention.

It is hypothesized that

1. this is a feasible intervention

2. this results in a decrease in the activity of the bacterial enzyme β-glucuronidase and the abundance of β-glucuronidase-producing bacteria. Which would be in line with the findings of in vitro and animal studies and

3. an increase in microbial diversity

Conditions

Microbial Colonization; Enzyme Overdose

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Apple intervention

the eating of 2 apples a day for a period of 6 weeks

Group Type: EXPERIMENTAL

Eating apples

Intervention Type: OTHER

the eating of 2 apples a day for a period of 6 weeks

Interventions

Eating apples

the eating of 2 apples a day for a period of 6 weeks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 50-64
• Postmenopausal women
• Recent negative breast cancer screening (< 6 months)

Exclusion Criteria

• The regular consumption of one ore more apples a day
• Previous gastrointestinal surgery (excl. appendix surgery)
• Any type of cancer in history, except for basal cell carcinoma (BCC)
• Inflammatory bowel disease
• Mammography older than 6 months
• Antibiotic use within three months before fecal sampling
• Physically or mentally incapable or incompetent to sign informed consent
• Known apple allergy or complaints matching with apple allergy
• Less good dental state

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marjolein Smidt, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Central Contacts

Marjolein Smidt, prof. dr.

Role: CONTACT

Phone: 043 - 3877477

Email: m.smidt@mumc.nl

Other Identifiers

METC22-064

Identifier Type: -

Identifier Source: org_study_id