Prunes for Osteoporosis

(Prune-UP Trial)

Overseen By Mary Jane De Souza, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Penn State University

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

Disqualifiers: Fractures, Thyroid issues, Renal impairment, others

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

Compensation: Varies

Number of Visits: 9

Duration: 18 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether eating prunes daily can prevent bone loss during the transmenopausal period, a time when women often experience rapid bone loss. The trial examines the effects of 18 months of eating prunes on bone health compared to not eating prunes. Women who have not had a menstrual period for at least 60 days but less than 18 months and are willing to eat prunes daily might be suitable candidates. If successful, the findings could lead to a simple dietary recommendation to help prevent osteoporosis in women. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could inform new dietary recommendations for bone health.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that affect bone metabolism, such as bisphosphonates, denosumab, and others listed in the exclusion criteria. If you're taking any of these, you may need to stop them before joining the study.

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

Research has shown that eating prunes daily is generally safe and may benefit bone health. One study found that consuming 50 grams of prunes each day strengthened hip bones in postmenopausal women within six months, with benefits lasting up to a year. Another study suggested that prunes can slow bone loss and reduce the risk of osteoporosis, a condition where bones become weak and brittle, in older women.

Overall, prunes are easy to digest, and no major negative effects have been reported when consumed in moderation. This makes them a safe option for those seeking to support bone health during menopause. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using prunes for osteoporosis because, unlike typical treatments like bisphosphonates or hormone-related therapies, prunes are a natural food source. Prunes contain high levels of phenolic compounds, which might play a role in bone health by reducing bone resorption, a process where bone is broken down and its minerals released into the bloodstream. Additionally, incorporating prunes into the diet could offer a more holistic and accessible approach to managing bone density, potentially reducing dependency on pharmaceuticals. This makes prunes a unique option that could complement existing treatments while being relatively easy to integrate into daily life.

What evidence suggests that prune consumption might be an effective treatment for bone loss?

Research has shown that eating prunes can help protect bones during menopause. In this trial, one group of participants will consume 50 grams of prunes daily along with calcium and vitamin D supplements. Studies have found that eating 50 grams of prunes daily can prevent hip bone loss in postmenopausal women over six to twelve months. This suggests that prunes might slow down bone loss related to osteoporosis. The positive effects may occur because prunes can reduce inflammation, which often contributes to bone weakening. Overall, prunes seem promising for maintaining bone health during this important time. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for perimenopausal women experiencing significant bone loss, who are interested in testing whether eating prunes can help prevent or slow down this process. Participants should be willing to consume prunes daily or take calcium and vitamin D supplements as part of the study.

Inclusion Criteria

Willing to include prunes in their daily diet

Non-smoking

I can walk on my own without help.

Exclusion Criteria

Subjects who regularly consume prunes, dried apples, prune juice, or are heavy consumers of blueberries (1 cup or more/day)

I have a history of heart attack, stroke, blood clots, kidney disease, malabsorption, or seizures.

I have been diagnosed with spinal stenosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants take calcium and vitamin D supplements daily to establish baseline measurements

4 weeks

Treatment

Participants consume 50g of prunes daily along with calcium and vitamin D supplements for 18 months

18 months

Visits at baseline, month 9, and month 18

Follow-up

Participants are monitored for changes in bone mineral density and other health markers

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prunes

Trial Overview The study tests if consuming 50g of prunes daily over 18 months during perimenopause can reduce bone loss compared to a control group not eating prunes. It will also look at how prunes might affect bone density, shape, inflammation markers, immune cell responses, and gut bacteria.

How Is the Trial Designed?

Group I: Calcium and Vitamin D - Control group Experimental Treatment 2 Interventions

Participants will take calcium and vitamin D supplements daily for a baseline period and for the duration of the intervention. Participants will be asked to refrain from consumption of prunes and fruits that have high phenolic content for the duration of the intervention (18 months).

Group II: 50g Prunes, Calcium, and Vitamin D - Intervention Group Experimental Treatment 3 Interventions

Participants will take calcium and vitamin D supplements daily for a baseline period and for the duration of the intervention. Additionally, participants will be provided with prunes and asked to consume 6 (50g) prunes per day for the duration of the intervention (18 months).

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

University of Georgia

Collaborator

Trials

109

Recruited

43,500+

California Dried Plum Board

Collaborator

Trials

3

Recruited

380+

United States Department of Agriculture (USDA)

Collaborator

Trials

103

Recruited

287,000+

Citations

1. 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.

2. 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 ... A yearlong randomized controlled trial found that daily prune consumption slowed bone loss connected to osteoporosis · UNIVERSITY PARK, Pa. · It's ...

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

The Role of Prunes in Modulating Inflammatory Pathways ... Overall, the clinical findings to date suggest that prune consumption may be effective in improving bone outcomes in postmenopausal women, possibly by ...

4. 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.

5. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(23)03609-2/fulltext

Prunes preserve hip bone mineral density in a 12-month ... Both 50-g and 100-g dosages of prunes are hypothesized to effectively prevent BMD loss in postmenopausal women.