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Dried Plums and Bone Health in Postmenopausal Women

NCT02822378 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2025-05-13

No results posted yet for this study

Summary

Postmenopausal women often seek non-pharmacologic interventions for the protection of bone health. Previous research in humans and rodents has indicated that dietary dried plum consumption may be beneficial for bone health, especially in postmenopausal women. However, it is unknown in what quantity dried plums need to be consumed to be of benefit and through what mechanisms dried plums act to impact bone health. Therefore, the purpose of this study is to evaluate the impact of 52 weeks of dried plums consumption in varying quantities on bone mineral density (BMD), bone geometry, and estimated bone strength in postmenopausal women. The investigators also seek to evaluate the mechanisms underlying the effects of dried plums as a dietary supplement by assessing polyphenols and the bioavailable conjugated metabolites in the urine of postmenopausal women taking different doses of dietary dried plums. The investigators aim to further investigate the mechanisms of dried plum action on bone by measuring markers of bone metabolism in response to dried plum consumption.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DIETARY_SUPPLEMENT

Dried Plum

Participants randomized to the 50g dried plum group will consume 6 dried plums per day for the duration of the 52 week intervention. Participants randomized to the 100g dried plum group will consume 12 dried plums per day for the duration of the 52 week intervention.

DIETARY_SUPPLEMENT

Calcium supplement

All participants will consume calcium supplements for the duration of baseline and intervention.

DIETARY_SUPPLEMENT

Vitamin D supplement

All participants will consume vitamin D supplements for the duration of baseline and intervention.

Sponsors & Collaborators

  • California Dried Plum Board

    collaborator OTHER

  • Penn State University

    lead OTHER

Principal Investigators

  • Mary Jane De Souza, PhD · The Pennsylvania State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02822378 on ClinicalTrials.gov