Prunes for Bone Health

Overseen By Shirin Hooshmand, PhD, RD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: San Diego State University

Must not be taking: Glucocorticoids, Neuroactive drugs

Disqualifiers: Smoking, BMD below 2.5 SD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 24 months

200 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial requires that you stop taking any drugs known to affect bone and calcium metabolism, such as certain endocrine or neuroactive drugs, before participating.

What data supports the effectiveness of the treatment Prunes, Dried Plums for bone health?

Research shows that eating prunes (dried plums) can help improve bone health by increasing bone mineral density and reducing bone loss, especially in postmenopausal women. Studies have found that prunes have anti-inflammatory and antioxidant effects, which may contribute to their ability to protect and strengthen bones. ^{1 2 3 4 5}

Is it safe for humans to consume prunes for bone health?

Research suggests that prunes (dried plums) are generally safe for human consumption, with no adverse effects noted in studies on bone health. They may also have beneficial effects on bone density and inflammation. ^{1 3 5 6 7}

How do prunes differ from other treatments for bone health?

Prunes (dried plums) are unique because they are a natural, non-pharmaceutical option that can both prevent and reverse bone loss, unlike many treatments that only prevent further deterioration. They contain phenolics that enhance bone formation and inhibit bone resorption, and they also have anti-inflammatory and antioxidant effects, which are not typical features of standard bone health treatments. ^{1 2 6 8 9}

Research Team

Shirin Hooshmand, PhD

Principal Investigator

San Diego State University

Eligibility Criteria

This trial is for postmenopausal women who have a bone mineral density (BMD) t-score between -0.5 and -2, indicating some loss of bone density but not severe osteoporosis. Participants should not be on hormone replacement therapy or other drugs affecting bone health for at least three months before the study starts.

Inclusion Criteria

I am postmenopausal.

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

I haven't taken hormone therapy or bone-affecting drugs in the last 3 months.

Exclusion Criteria

Subjects who smoke cigarettes or vape

Regular consumption of dried plum or prune juice

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 500 mg calcium and 400 IU vitamin D daily, with one group also receiving 30 g of prunes daily for 24 months

24 months

Visits at baseline, 12 months, and 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Prunes

Trial Overview The study is testing whether prunes, in combination with calcium and vitamin D supplements, can help prevent further bone loss in postmenopausal women compared to just taking the supplements alone.

Participant Groups

Group I: 30 g prune/day Experimental Treatment 1 Intervention

Participants receive 500 mg calcium and 400 IU vitamin D daily for 24 months and 30 g of prune daily for 24 months.

Group II: Control (0 g prune/day) Active Control 1 Intervention

Participants only receive 500 mg calcium and 400 IU vitamin D daily for 24 months.

Prunes is already approved in United States, European Union for the following indications:

Approved in United States as Prunes/Dried Plums for:

• General health supplement
• Supports bone health

Approved in European Union as Prunes/Dried Plums for:

• General health supplement
• Supports bone health

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

Findings from Research

Prunes have shown promising osteoprotective effects in both preclinical studies and clinical trials, helping to prevent and reverse bone loss in models of osteoporosis and in postmenopausal women, with doses of 50-100 g/d over 6-12 months improving bone mineral density.

In addition to their antiresorptive properties, prunes also exhibit anti-inflammatory and antioxidant effects, which may further support bone health by reducing oxidative stress and inflammation, although more research is needed to fully understand these mechanisms in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Prunes in Modulating Inflammatory Pathways to Improve Bone Health in Postmenopausal Women. Damani, JJ., De Souza, MJ., VanEvery, HL., et al.[2023]

Dried plums (prunes) have been shown to effectively prevent and even reverse bone loss in both animal studies and a 3-month clinical trial involving postmenopausal women, indicating their potential as a non-pharmacological treatment for osteoporosis.

In animal models, dried plums not only protected against bone density loss but also restored bone mineral density and improved trabecular bone structure, demonstrating effects comparable to traditional treatments like parathyroid hormone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Viewpoint: dried plum, an emerging functional food that may effectively improve bone health. Hooshmand, S., Arjmandi, BH.[2019]

In a study involving 35 men aged 55 to 80 with low bone mineral density, consuming 100 g of prunes daily significantly reduced serum osteocalcin, a marker of bone turnover, indicating potential benefits for bone health.

Consuming 50 g of prunes daily also showed positive effects by decreasing serum osteoprotegerin and increasing the OPG:RANKL ratio, suggesting that prunes may help improve bone metabolism and reduce inflammation related to osteoporosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Short-Term Effect of Prunes in Improving Bone in Men. George, KS., Munoz, J., Ormsbee, LT., et al.[2022]

In a study involving 160 postmenopausal women, dried plum (100 g/day) significantly improved bone mineral density (BMD) in the ulna and spine compared to a control group consuming dried apple.

Dried plum also effectively reduced serum levels of bone turnover markers, indicating that it may help in reversing bone loss by slowing down the rate of bone turnover in osteopenic women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effects of dried plum and dried apple on bone in postmenopausal women. Hooshmand, S., Chai, SC., Saadat, RL., et al.[2016]

In a study involving 27 healthy postmenopausal women, consuming six dried plums (approximately 42g) daily for two weeks showed a trend towards reduced bone resorption, indicated by a decrease in serum C-telopeptide levels during the second phase of the study.

No significant effects on vascular function were observed, but there was an interaction between treatment and years after menopause regarding arterial stiffness, suggesting that dried plums may have a favorable impact on bone health in postmenopausal women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Short-Term Dried Plum (Prune) Intake on Markers of Bone Resorption and Vascular Function in Healthy Postmenopausal Women: A Randomized Crossover Trial. Al-Dashti, YA., Holt, RR., Carson, JG., et al.[2020]

A comprehensive review of 24 studies indicates that dried plums (prunes) may enhance bone health by promoting bone formation and inhibiting bone resorption, likely due to their phenolic content and effects on cell signaling pathways.

No adverse effects were reported in the studies, suggesting that dried plums can be safely included in the diet of postmenopausal women to potentially protect against bone loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dried Plums, Prunes and Bone Health: A Comprehensive Review. Wallace, TC.[2018]

The Prune Study is a large randomized controlled trial involving 235 postmenopausal women that investigates the effects of daily prune consumption on bone health and various health biomarkers over 12 months.

Participants were divided into three groups (control, 50g prunes, and 100g prunes), and all received standard care with calcium and vitamin D, making this the most comprehensive study to date on how prunes may improve bone mineral density and overall health in postmenopausal women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and study design of Randomized Controlled Trial of Dietary Supplementation with prune (dried plums) on bone density, geometry, and estimated bone strength in postmenopausal women: The Prune study. De Souza, MJ., Strock, NCA., Rogers, CJ., et al.[2022]

Daily consumption of 50 g of dried plum for 6 months is effective in preventing bone loss in older osteopenic postmenopausal women, showing similar efficacy to 100 g, which suggests a potential for lower dosage without compromising benefits.

Both doses of dried plum significantly reduced bone resorption markers, indicating that the mechanism of action may involve inhibiting bone loss while maintaining bone formation, as evidenced by changes in the BAP/TRAP-5b ratio.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of two doses of dried plum on bone density and bone biomarkers in osteopenic postmenopausal women: a randomized, controlled trial. Hooshmand, S., Kern, M., Metti, D., et al.[2018]

A study on aged, osteopenic rats showed that a crude polyphenol extract from dried plum significantly restored bone mineral density and reduced bone resorption, indicating its potential as an effective treatment for bone health.

The combination of polyphenols, potassium, and vitamin K was found to reverse bone loss in both the spine and femur, highlighting the synergistic effects of these components in promoting bone health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dried Plum Polyphenolic Extract Combined with Vitamin K and Potassium Restores Trabecular and Cortical Bone in Osteopenic Model of Postmenopausal Bone Loss. Graef, JL., Ouyang, P., Wang, Y., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Role of Prunes in Modulating Inflammatory Pathways to Improve Bone Health in Postmenopausal Women. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Viewpoint: dried plum, an emerging functional food that may effectively improve bone health. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Short-Term Effect of Prunes in Improving Bone in Men. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Comparative effects of dried plum and dried apple on bone in postmenopausal women. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of Short-Term Dried Plum (Prune) Intake on Markers of Bone Resorption and Vascular Function in Healthy Postmenopausal Women: A Randomized Crossover Trial. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Dried Plums, Prunes and Bone Health: A Comprehensive Review. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Rationale and study design of Randomized Controlled Trial of Dietary Supplementation with prune (dried plums) on bone density, geometry, and estimated bone strength in postmenopausal women: The Prune study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The effect of two doses of dried plum on bone density and bone biomarkers in osteopenic postmenopausal women: a randomized, controlled trial. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Dried Plum Polyphenolic Extract Combined with Vitamin K and Potassium Restores Trabecular and Cortical Bone in Osteopenic Model of Postmenopausal Bone Loss. [2020]