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Prebiotics (Dried Plum) and Immune Function in Postmenopausal Women

Indiana University · with Purdue University · NCT07222111

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 60–75 · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
30
US sites recruiting
1
Study start
September 2, 2025
Record last updated
October 29, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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:

  • Does adding dried plums to the diet alter immune cell function?
  • Does dried plum alter gut microbes?
  • 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

  • Consume their normal diet or supplement their normal diet dried plums for four week periods over the course of 3-4 months.
  • Complete 5 study visits scheduled.
  • Perform some physical function tests and have a bone density scan at the beginning of the study.
  • Complete questionnaires, a 3-day food record, and provide stool and blood samples at 4 different timepoints during the study.
  • Record information about their bowel habits

Being studied: Dried plums

Conditions: T Cell Response to Dried Plum; Vitamin D Influence on Immune Response; Dried Plum and Immune Function

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • women 60-75 years of age at the start of the study;
  • 12 or more consecutive months without a menstrual period;
  • willing to include dried plums in their daily diet and collect fecal samples at four time points;
  • ambulatory without assistance;
  • capacity to give informed consent.

Exclusion Criteria

  • women who have been on medications known to alter bone or calcium metabolism (e.g., oral bisphosphonates, raloxifene, denosumab, intermittent parathyroid hormone, growth hormone) within 12 months of starting the study. Prior use of intravenous bisphosphonates at any time.
  • women who have been on hormone replacement therapy, steroids (i.e., glucocorticoids), biologics, or chronic NSAID within 3 months of starting the study.
  • women with a previous diagnosis of osteoporosis (i.e., BMD T-score or history of vertebral fracture or fragility fractures of hip, wrist, humerus after the age of 50 yr) or other metabolic bone disease (e.g., osteomalacia or osteogenesis imperfect), renal disease, stroke, heart attack, type 2 diabetes, liver disease or autoimmune diseases (e.g., rheumatoid arthritis, systemic Lupus erythematosus, type 1 diabetes mellitus, IBD) that could affect bone metabolism or T cell biology will be excluded.
  • women who have undergone treatment for cancer within 12 months of starting the study
  • women who have been taking prebiotic or probiotic supplements or natural products that have estrogen-like effects in the past 3 months
  • women who smoke, have a BMI >40 kg/m2 or \<18.5 kg/m2, or consume >2 alcoholic drinks per day
  • women who regularly consume dried plums or prune juice (>1 serving weekly).

Recruiting US locations

  • IU Health University Hospital Clinical Research Center

    Indianapolis, IN 46202

    Site contact: Brenda J. Smith, Ph.D. · 317-278-5150 · bsm14@iu.edu

All nutrition & metabolism studies in Indiana →
Prebiotics (Dried Plum) and Immune Function in Postmenopausal Women (NCT07222111) | Bored Studies