Actively Recruiting

Phase Not Applicable
Age: 60Years - 75Years
FEMALE
Healthy Volunteers
NCT07222111

Prebiotics (Dried Plum) and Immune Function in Postmenopausal Women

Led by Indiana University · Updated on 2025-10-29

30

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

I

Indiana University

Lead Sponsor

P

Purdue University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Prior studies have shown that dietary supplementation with dried plums (also known as prunes) reduces bone loss in postmenopausal women. The purpose of this clinical trial is to understand how dried plums mediate their effects on bone. The main questions the study will answer are: 1. Does adding dried plums to the diet alter immune cell function? 2. Does dried plum alter gut microbes? 3. Does a person's vitamin D status influence this response? Researcher will compare the response following consumption of the normal diet to supplementing the diet with dried plums. Participant will: 1. Consume their normal diet or supplement their normal diet dried plums for four week periods over the course of 3-4 months. 2. Complete 5 study visits scheduled. 3. Perform some physical function tests and have a bone density scan at the beginning of the study. 4. Complete questionnaires, a 3-day food record, and provide stool and blood samples at 4 different timepoints during the study. 5. Record information about their bowel habits

CONDITIONS

Official Title

Prebiotics (Dried Plum) and Immune Function in Postmenopausal Women

Who Can Participate

Age: 60Years - 75Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 60 to 75 years at the start of the study
  • At least 12 consecutive months without a menstrual period
  • Willing to include dried plums in their daily diet and collect fecal samples at four time points
  • Able to walk without assistance
  • Able to give informed consent
Not Eligible

You will not qualify if you...

  • Use of medications altering bone or calcium metabolism within 12 months before the study, including oral bisphosphonates, raloxifene, denosumab, parathyroid hormone, or growth hormone; any prior use of intravenous bisphosphonates
  • Use of hormone replacement therapy, steroids, biologics, or chronic NSAIDs within 3 months before the study
  • Previous diagnosis of osteoporosis or other metabolic bone diseases, renal disease, stroke, heart attack, type 2 diabetes, liver disease, or autoimmune diseases affecting bone or T cell biology
  • Cancer treatment within 12 months before the study
  • Use of prebiotic or probiotic supplements or natural products with estrogen-like effects in the past 3 months
  • Smoking, body mass index over 40 kg/m2 or under 18.5 kg/m2, or consuming more than 2 alcoholic drinks per day
  • Regular consumption of dried plums or prune juice more than once per week

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IU Health University Hospital Clinical Research Center

Indianapolis, Indiana, United States, 46202

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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