MedDataX Logo

Dried Plums for Bone Health in Older Postmenopausal Women

NCT ID: NCT02325895

Last Updated: 2014-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of the investigators current study was to examine whether 50 g dried plum would be as effective as 100 g dried plum in reversing bone loss in osteopenic older postmenopausal women.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Forty-five randomly assigned into one of three treatment groups: 1) 50g dried plum; 2) 100g dried plum; and 3) control (0g dried plum). All groups received 500mg calcium and 400 IU vitamin D as a daily supplement. Blood samples were collected at baseline, 3 and 6 months to assess biomarkers of bone turnover. Physical activity recall and 3-day food records were obtained at baseline, 3 and 6 months to examine physical activity and dietary confounders as potential covariates

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bone Diseases, Metabolic

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Osteoporosis Dried plum functional food

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control (0 g Dried plum/day)

Participants only received 400IU of vitamin D and 500mg of calcium daily for 6 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

50 g Dried plum/day

Participants received 400IU of vitamin D and 500mg of calcium and 50g of dried plum daily for 6 months.

Group Type EXPERIMENTAL

Dried Plum

Intervention Type OTHER

Three doses of dried plum (0 g, 50 g and 100g) were used as intervention.

100 g Dried plum/day

Participants received 400IU of vitamin D and 500mg of calcium and 100g of dried plum daily for 6 months.

Group Type EXPERIMENTAL

Dried Plum

Intervention Type OTHER

Three doses of dried plum (0 g, 50 g and 100g) were used as intervention.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dried Plum

Three doses of dried plum (0 g, 50 g and 100g) were used as intervention.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* BMD t-score of L1-L4 between -1 to -2.5 standard deviation of the mean
* Age 65 to 79

Exclusion Criteria

* BMD t-score at any site fell below 2.5 standard deviation of the mean
* Subjects treated with calcitonin, bisphosphonates, raloxifene and/or anabolic agents such as parathyroid hormone and growth hormone, or steroids within three months before the start of the study
* Metabolic bone disease, renal disease, cancer, CVD, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease or other chronic diseases, heavy smoking (more than twenty cigarettes/day) and current use of any prescription medications known to alter bone and calcium metabolism
* Regularly consumed dried plum or prune juice were not included in the study.
Minimum Eligible Age

65 Years

Maximum Eligible Age

79 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Florida State University

OTHER

Sponsor Role collaborator

San Diego State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Shirin Hooshmand

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shirin Hooshmand, PhD

Role: PRINCIPAL_INVESTIGATOR

San Diego State Univeristy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26902092 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

57114A

Identifier Type: -

Identifier Source: org_study_id