NCT07222111 · Indiana University
Prebiotics (Dried Plum) and Immune Function in Postmenopausal Women
What this 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: 1. Does adding dried plums to the diet alter immune cell function? 2. Does dried plum alter gut microbes? 3.
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
Dried plums
Participants will supplement their regular diet with 50 g of dried plum (5-6 dried plums) per day.
Primary outcome measures
Change in Circulating T Helper (Th)17 Cells
Time frame: Change from baseline to the end of each 4-week arm of the study
Change in the relative abundance of circulating Th17 cells in response to dried plum supplementation compared to control arm of the study will be reported.
Ex Vivo T Cell Function
Time frame: The end of each 4 week arm of the study
Ex vivo experiements will be performed with peripheral blood mononuclear cells (PBMCs) collected at the final time points of each of the two arms (4 weeks in duration) of the study. Cells will be challenged and the release of interleukin 17 and interleukin 10 will be assessed in the media. The cytokine response of cells collected at the end of the control or dried plum treatment arm arm will be assessed.
Treatment Effects on Serum IL-6
Time frame: End of the 4-week control and dried plum treatment arm of the study.
Serum IL-6 will be compared at the end of the control arm and at the end of dried plum supplementation arm of the study.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Indianapolis, Indiana
Collaborators
Purdue University
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 29, 2025 · Source of record for eligibility and locations