Dried Plums for Osteoporosis

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Penn State University

Must not be taking: Bisphosphonates, Denosumab, Estrogen, others

Disqualifiers: Vitamin D deficiency, Fractures, Thyroid issues, others

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

Compensation: Varies

Number of Visits: 6

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether eating dried plums can improve bone health in postmenopausal women. By examining different daily quantities of dried plums, the researchers aim to determine their effect on bone strength and density. Participants will either consume dried plums or take calcium and vitamin D supplements for a year. Postmenopausal women with low bone density who are willing to eat dried plums daily may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance bone health for many women.

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications that affect bone metabolism, such as bisphosphonates, denosumab, and others, for specific periods before joining. You also need to stop taking natural dietary supplements containing phenolics, blueberries, or apples for at least 2 months before the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that postmenopausal women can safely eat dried plums. Studies have found that consuming dried plums daily is not only safe but may also enhance bone health in these women. Specifically, research involving amounts between 50 to 100 grams per day over six to twelve months revealed no serious safety concerns. This indicates that dried plums are well-tolerated and could be a beneficial choice for those seeking to support their bone health naturally. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for osteoporosis, which often include medications like bisphosphonates or hormone-related therapies, these investigational treatments use dried plums as a natural alternative. Researchers are excited because dried plums are packed with nutrients like potassium and vitamin K, which might help improve bone density. This approach offers a potential dietary solution with fewer side effects than traditional drugs. By incorporating either 50g or 100g of dried plums daily, alongside calcium and vitamin D supplements, this treatment could provide a tasty and accessible way to boost bone health.

What evidence suggests that dried plums might be an effective treatment for osteoporosis?

Research shows that dried plums, or prunes, can benefit bone health in postmenopausal women. In this trial, participants will be divided into groups to assess the effects of dried plums on bone health. One group will consume 50 grams of dried plums daily, while another will consume 100 grams daily. Studies have found that eating 50 grams of prunes daily can help prevent bone density loss in the hip, with benefits lasting up to a year. Other research indicates that consuming 50 to 100 grams of prunes daily can support bone health over 6 to 12 months. Tests on animals and cells suggest that prunes may help by boosting bone growth and slowing bone loss. Overall, these findings suggest that regularly eating prunes might help maintain strong and healthy bones. ^{1 4 5 6 7}

Who Is on the Research Team?

Mary Jane De Souza, PhD

Principal Investigator

The Pennsylvania State University

Are You a Good Fit for This Trial?

This trial is for postmenopausal women with low bone mineral density but not severe obesity or significant health issues like heart disease, kidney problems, or untreated thyroid conditions. Participants should be non-smokers, able to walk, and willing to eat dried plums daily without taking other natural dietary supplements.

Inclusion Criteria

I can walk on my own without help.

I am a woman who has gone through menopause.

I haven't taken supplements with phenolics, blueberries, or apples for 2 months.

Exclusion Criteria

I have a history of heart, blood clot, kidney issues, malabsorption, or seizures.

I have had a bone fracture after age 50.

Women who eat a lot of dried plums, dried apples, prune juice, or blueberries (1 cup or more/day) need to stop eating these foods for at least 2 months before joining the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline

Participants undergo baseline assessments before randomization

1-2 weeks

1 visit (in-person)

Treatment

Participants consume dried plums and calcium/vitamin D supplements for 52 weeks with regular laboratory visits

52 weeks

Visits every 4 weeks, with additional testing at weeks 12, 24, 36, and 52

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dried Plum

Trial Overview The study tests the effects of eating different amounts of dried plums for a year on bone strength in postmenopausal women. It will measure changes in bone density and investigate how compounds from the plums might affect bone metabolism.

How Is the Trial Designed?

Group I: Ca2+/VitD Control Experimental Treatment 2 Interventions

Participants will take calcium and vitamin D supplements for the duration of the baseline and intervention. Participants will be asked to refrain from consumption of dried plums for the duration of the intervention (52 weeks).

Group II: 50g Dried Plums Experimental Treatment 3 Interventions

Participants will take calcium and vitamin D supplements for the duration of the baseline and intervention. Additionally, participants will be provided with dried plums and asked to consume 6 (50g) dried plums per day for the duration of the intervention (52 weeks).

Group III: 100g Dried Plums Experimental Treatment 3 Interventions

Participants will take calcium and vitamin D supplements for the duration of the baseline and intervention. Additionally, participants will be provided with dried plums and asked to consume 12 (100g) dried plums per day for the duration of the intervention (52 weeks).

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

California Dried Plum Board

Collaborator

Trials

3

Recruited

380+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28422064/

Dried Plums, Prunes and Bone Health: A Comprehensive ... Animal and cell studies suggest that dried plums and/or their extracts enhance bone formation and inhibit bone resorption through their actions ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35798020/

Prunes preserve hip bone mineral density in a 12-month ... A 50-g daily dose of prunes can prevent loss of total hip BMD in postmenopausal women after 6 mo, which persisted for 12 mo.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2161831323000236

The Role of Prunes in Modulating Inflammatory Pathways ... Two clinical trials have investigated the impact of dried plum consumption (50–100 g/d for 6–12 mo) on bone health in postmenopausal women and demonstrated ...

4. psu.edu psu.edu/news/research/story/got-prunes-prunes-may-preserve-bone-density-and-strength-older-women

Got prunes? Prunes may preserve bone density and ... Eating prunes daily may protect bone structure and strength in postmenopausal women, slowing the progression of age-related bone loss and reducing the risk of ...

5. breastcancer.org breastcancer.org/news/prunes-for-bone-health

Study: Prunes Protect Bone Structure and Strength A new study found that eating four to 12 prunes per day helps maintain bone density and bone strength in post-menopausal women.

6. melioguide.com melioguide.com/osteoporosis-nutrition/prunes-for-osteoporosis/

Prunes for Osteoporosis, Osteopenia, and Bone Health Research demonstrates that daily consumption of prunes is beneficial for post-menopausal women with osteoporosis.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5409740/

Dried Plums, Prunes and Bone Health - PubMed Central - NIH This comprehensive review supports that consumption of dried plums is safe and may be a bone healthy option for postmenopausal women wishing to ...