Status:
RECRUITING
Prebiotics (Dried Plum) and Immune Function in Postmenopausal Women
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Indiana University School of Medicine
Purdue University
Conditions:
T Cell Response to Dried Plum
Vitamin D Influence on Immune Response
Eligibility:
FEMALE
60-75 years
Phase:
NA
Brief Summary
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 p...
Detailed Description
Each year in the U.S., an estimated 2 million women (\~6,000 women each day) reach the critical stage of female reproductive aging known as menopause. Menopause is characterized by the permanent cessa...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07222111
Start Date
September 2 2025
End Date
August 30 2028
Last Update
October 29 2025
Active Locations (1)
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1
IU Health University Hospital Clinical Research Center
Indianapolis, Indiana, United States, 46202