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

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05748080

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Microbial Colonization Enzyme Overdose	Other: Eating apples	N/A

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

this is a feasible intervention
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
an increase in microbial diversity

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Two Apples a Day, Keep the Doctor Away?

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Oct 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Apple intervention the eating of 2 apples a day for a period of 6 weeks	Other: Eating apples the eating of 2 apples a day for a period of 6 weeks

Arm

Intervention/Treatment

Experimental: Apple intervention

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

Other: Eating apples

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

Outcome Measures

Primary Outcome Measures

The activity of the bacterial enzyme β-glucuronidase and the abundance of β-glucuronidase-producing bacteria [6 weeks per patient]
This will be measured in fecal samples by using a validated β-glucuronidase enzyme activity assay, which is based on previous studies.
Changes in gut microbiota composition, diversity, and functional capacity [6 weeks per patient]
Gut microbiota composition, diversity
Feasibility of eating 2 apples a day for a period of 6 weeks [6 weeks per patient]
feasibility

Secondary Outcome Measures

Fecal levels of short-chain fatty acids (SCFA) [6 weeks per patient]
SCFA
Dietary intake, medication, stool classification and frequency, blood pressure, weight, length and quality of life before and after the intervention [6 weeks per patient]
diet/medication etc

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 64 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Maastricht University Medical Center

Investigators

Principal Investigator: Marjolein Smidt, prof. dr., Maastricht University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maastricht University Medical Center

ClinicalTrials.gov Identifier:

NCT05748080

Other Study ID Numbers:

METC22-064

First Posted:

Feb 28, 2023

Last Update Posted:

Feb 28, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Communicable Diseases

Infections

Study Results

No Results Posted as of Feb 28, 2023