Elucidating the Minimal Effective Dose of Prunes for Bone Health in Postmenopausal Women

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorSan Diego State University

About this trial

The objective of this study is to examine if calcium and vitamin D supplements and/or prune can prevent bone loss in postmenopausal women.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Postmenopausal

BMD t-score is between 0.5 and 2 SD below the mean

Not on hormone replacement therapy (HRT) and/or other pharmacological agents known to affect bone for at least three months prior to initiation of the study

Disqualifiers

Women whose BMD t-score at any site falls below 2.5 SD of the mean

Subjects receiving endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism

Subjects who smoke cigarettes or vape

Regular consumption of dried plum or prune juice

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prune

    Dietary supplement

    30 g of prune/day

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Control (0 g prune/day)No intervention 0 interventions
Group B: 30 g prune/dayExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes from baseline in bone mineral density at 12 and 24 months

bone mineral density as assessed by dual energy x-ray absorptiometry

Time frame
Baseline, 12 months, and 24 months

Secondary outcomes

1

Changes from baseline in bone specific alkaline phosphatase at 12 months and 24 months

bone specific alkaline phosphatase (BAP) as assessed with ELISA

Time frame
Baseline, 12 months, and 24 months
2

Changes from baseline in tartrate acid phosphatase-5b at 12 months and 24 months

tartrate acid phosphatase-5b (TRAP5b) as assessed with ELISA

Time frame
Baseline, 12 months, and 24 months

Other outcomes

Sponsors and contacts

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