Dried plums (prunes) and immune function in postmenopausal women.
Prebiotics in Women's Health and Aging: The Gut-Bone Connection
This trial will test whether eating dried plums (prunes) for several weeks changes immune cell behavior and gut bacteria in postmenopausal women and whether vitamin D levels affect that response.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 60 Years to 75 Years |
| Sex | Female |
| Sponsor | Indiana University Academic / other |
| Drugs / interventions | denosumab |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT07222111 on ClinicalTrials.gov |
What this trial studies
Postmenopausal women aged 60–75 will alternate between their normal diet and a diet supplemented with dried plums during four-week periods over 3–4 months, with five clinic visits overall. Investigators will collect blood and stool samples at multiple timepoints, perform baseline bone density and physical function tests, and track diet with food records and questionnaires. The study compares immune cell (T cell) responses and gut microbiome composition before and after dried plum supplementation and examines whether baseline vitamin D status modifies those effects. Data will be used to link changes in microbes and immune markers to known bone-protective effects of dried plums.
Who should consider this trial
Good fit: Ideal candidates are ambulatory postmenopausal women aged 60–75 who can eat dried plums daily, provide stool and blood samples, complete food records and clinic visits, and are not taking excluded bone- or immune-altering medications.
Not a fit: Women with diagnosed osteoporosis, recent or current use of bone-active drugs, hormone therapy, chronic steroids/biologics/NSAIDs, or those unable to comply with sample collection or clinic visits are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could identify a simple, low-cost dietary approach that helps support immune-related bone health in postmenopausal women.
How similar studies have performed: Prior clinical work has shown dried plums can reduce bone loss in postmenopausal women, but using dried plums to modify T-cell responses or the gut microbiome is relatively novel with limited direct human data.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Indianapolis, Indiana
- IU Health University Hospital Clinical Research Center — Indianapolis, Indiana, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.