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_SUPPLEMENT
    Participants 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 Plum
    Participants will consume their usual diet supplemented with 50 g of dried plum (5-6 dried plums) per day.
  • No Intervention: Regular Diet
    Participants 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)

FacilityCityStateZIPSite coordinators
IU Health University Hospital Clinical Research CenterIndianapolisIndiana46202
Brenda J. Smith, Ph.D.
317-278-5150
Laurie L Trevino
(317) 274-0952
Brenda J. Smith, PhD (PRINCIPAL_INVESTIGATOR)
Jessica Parker, MD (SUB_INVESTIGATOR)
Tom O'Connell, PhD (SUB_INVESTIGATOR)
Annabel Biurette, PhD (SUB_INVESTIGATOR)

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