Recruiting

Dried Plums

Sponsor:

Indiana University

Code:

NCT07222111

Conditions

T Cell Response to Dried Plum

Vitamin D Influence on Immune Response

Dried Plum and Immune Function

Eligibility Criteria

Sex: Female

Age: 60 - 70+

Healthy Volunteers: Accepted

Interventions

Dried plums

Study Details

Brief summary:

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

Conditions

T Cell Response to Dried Plum

Vitamin D Influence on Immune Response

Dried Plum and Immune Function

Study ID

NCT07222111

Start date

Sep 2, 2025

Status verified date

Sep, 2025

Completion date

Aug 30, 2028

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 60 - 70+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Dried plums

Participants will supplement their regular diet with 50 g of dried plum (5-6 dried plums) per day.

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 ]
  • Ex Vivo T Cell Function [ Time Frame: The end of each 4 week arm of the study ]
  • Treatment Effects on Serum IL-6 [ Time Frame: End of the 4-week control and dried plum treatment arm of the study. ]

Central Contacts and Locations

Locations

IU Health University Hospital Clinical Research Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Brenda J. Smith, Ph.D.

317-278-5150bsm14@iu.edu

Laurie L Trevino

(317) 274-0952lhackwar@iu.edu

Principal Investigator:

Brenda J. Smith, PhD

More Information

Sponsor

Indiana University

Last update posted

Oct 29, 2025

Last verified

Sep, 2025

Keywords

  • immune system
  • dried plums
  • prebiotics
  • T cells
  • bone health
  • vitamin D

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2025-10-29.