Prebiotics (Dried Plum) and Immune Function in Postmenopausal Women
Part of paid clinical trials in Indianapolis, Indiana.
- Sponsor
- Indiana University
- Study ID
- NCT07222111
- Status
- Recruiting
Conditions
- Dried Plum and Immune Function
- T Cell Response to Dried Plum
- Vitamin D Influence on Immune Response
Eligibility Criteria
- Sex
- FEMALE
- Age
- 60 Years - 75 Years
- Healthy Volunteers
- Accepted
Interventions
- Dried plums — DIETARY_SUPPLEMENTParticipants will supplement their regular diet with 50 g of dried plum (5-6 dried plums) per day.
Study Details
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 Dates
- Start date
- Sep 2, 2025
- Status verified
- Sep 2025
- Primary completion
- Aug 30, 2027
- Completion
- Aug 30, 2028
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Dried PlumParticipants will consume their usual diet supplemented with 50 g of dried plum (5-6 dried plums) per day.
- No Intervention: Regular DietParticipants will consume their usual diet.
Primary Outcome Measure
Change in Circulating T Helper (Th)17 Cells [ Time Frame: Change from baseline to the end of each 4-week arm of the study ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| IU Health University Hospital Clinical Research Center | Indianapolis | Indiana | 46202 | Brenda J. Smith, PhD (PRINCIPAL_INVESTIGATOR) Jessica Parker, MD (SUB_INVESTIGATOR) Tom O'Connell, PhD (SUB_INVESTIGATOR) Annabel Biurette, PhD (SUB_INVESTIGATOR) |