Prebiotics (Dried Plum) and Immune Function in Postmenopausal Women

Recruiting now · Not applicable

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

In brief

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

Key facts

Study ID: NCT07222111
Run by: Indiana University
People needed: 30
Starts: 2025-09-02
Expected to finish: 2028-08-30
Last updated by the study team: 2025-10-29

Who can join

Age: 60 and older, up to 75. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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).

Where it is running

IU Health University Hospital Clinical Research Center — Indianapolis, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

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