Prebiotics (Dried Plum) and Immune Function in Postmenopausal Women

NCT07222111 | Recruiting

• 2 other identifiers: IRB# 232322024-67017-42495
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.Does adding dried plums to the diet alter immune cell function?
2. 2.Does dried plum alter gut microbes?
3. 3.Does a person's vitamin D status influence this response?
4. 4.Consume their normal diet or supplement their normal diet dried plums for four week periods over the course of 3-4 months.
5. 5.Complete 5 study visits scheduled.
6. 6.Perform some physical function tests and have a bone density scan at the beginning of the study.
7. 7.Complete questionnaires, a 3-day food record, and provide stool and blood samples at 4 different timepoints during the study.
8. 8.Record information about their bowel habits

Conditions

T Cell Response to Dried Plum; Vitamin D Influence on Immune Response; Dried Plum and Immune Function

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Change in Circulating T Helper (Th)17 Cells

  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.

  Change from baseline to the end of each 4-week arm of the study

• Ex Vivo T Cell Function

  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.

  The end of each 4 week arm of the study

• Treatment Effects on Serum IL-6

  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.

  End of the 4-week control and dried plum treatment arm of the study.

Secondary Outcomes (8)

• Change in Circulating T Regulatory Cells

  Change from baseline to the end of each 4-week arm of the study

• Change in the Treg to Th17 ratio

  The change from baseline until final time points of each arm of each 4-week arm of the study.

• Ex Vivo T Cell TNF-a

  Sample collected at the end of each 4-week arm of the study

• Change in Serum Metabolites

  The change from baseline until final time points of each arm of each 4-week arm of the study.

• Change in Fecal Metabolites

  The change from baseline until final time points of each arm of each 4-week arm of the study.

Other Outcomes (3)

• Dietary Assessment

  Baseline and at the completion of each 4-week arm of the study.

• Physical Activity Assessment

  Prior to and at the completion of each 4-week arm of the study

• Body weight

  Prior to and at the completion of each 4-week study arm

Study Arms (2)

Dried Plum

EXPERIMENTAL

Participants will consume their usual diet supplemented with 50 g of dried plum (5-6 dried plums) per day.

Dietary Supplement: Dried plums

Regular Diet

NO INTERVENTION

Participants will consume their usual diet.

Interventions

Dried plums DIETARY_SUPPLEMENT

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

Dried Plum

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women 60-75 years of age at the start of the study;
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Indiana University: lead
• Indiana University School of Medicine: collaborator
• Purdue University: collaborator

Study Sites (1)

IU Health University Hospital Clinical Research Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Related Publications (3)

• Hooshmand S, Kern M, Metti D, Shamloufard P, Chai SC, Johnson SA, Payton ME, Arjmandi BH. The effect of two doses of dried plum on bone density and bone biomarkers in osteopenic postmenopausal women: a randomized, controlled trial. Osteoporos Int. 2016 Jul;27(7):2271-2279. doi: 10.1007/s00198-016-3524-8. Epub 2016 Feb 22.

  PMID: 26902092 BACKGROUND

• Hooshmand S, Chai SC, Saadat RL, Payton ME, Brummel-Smith K, Arjmandi BH. Comparative effects of dried plum and dried apple on bone in postmenopausal women. Br J Nutr. 2011 Sep;106(6):923-30. doi: 10.1017/S000711451100119X. Epub 2011 May 31.

  PMID: 21736808 BACKGROUND

• De Souza MJ, Strock NCA, Williams NI, Lee H, Koltun KJ, Rogers C, Ferruzzi MG, Nakatsu CH, Weaver C. Prunes preserve hip bone mineral density in a 12-month randomized controlled trial in postmenopausal women: the Prune Study. Am J Clin Nutr. 2022 Oct 6;116(4):897-910. doi: 10.1093/ajcn/nqac189.

  PMID: 35798020 BACKGROUND

Related Links

• All IN for Health is a platform made availabe through the NIH supported, Indiana Clinical and Translational Sciences Institute to improve resident's participation in clinical trials.

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice-chair of Translational Research in OBGYN

Model Details: The two study arms are normal diet (control) or normal diet supplemented with dried plum (intervention).

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: October 29, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2028
• Last Updated: October 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: August 2029
• Access Criteria: Investigators with PI permission

Locations

US (1)