Dried Plums for Postmenopausal Health

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Bisphosphonates, Steroids, Biologics, others

Disqualifiers: Osteoporosis, Diabetes, Cancer, others

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

Compensation: Varies

Number of Visits: 6

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how dried plums (prunes) may benefit bone health in postmenopausal women. Researchers aim to determine if adding dried plums to the diet affects immune cells, gut bacteria, and the role of vitamin D. Participants will follow either their regular diet or one with dried plums for a few months. Women who haven't had a period for over a year, are between 60-75, and can walk without assistance are ideal candidates.

As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding and potentially improve bone health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you've been on certain medications like those affecting bone or calcium metabolism, hormone replacement therapy, or steroids within the past 3-12 months. It's best to discuss your specific medications with the trial team.

What prior data suggests that dried plums are safe for postmenopausal women?

In a previous study, eating 50 grams of dried plums daily helped maintain hip bone strength in postmenopausal women over a year. Research has shown that eating prunes daily might slow bone loss and lower fracture risk. Two clinical trials found that consuming 50 to 100 grams of dried plums for six to twelve months is generally safe for bone health. Another review suggested that dried plums can be safely included in the diet of postmenopausal women. Overall, these studies suggest that dried plums are well-tolerated and can be safely added to the diet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for postmenopausal health, which often involve hormone replacement therapies or calcium and vitamin D supplements, dried plums offer a natural, dietary solution. Researchers are excited about these treatments because dried plums are rich in antioxidants and nutrients that may support bone health and reduce inflammation. Additionally, incorporating dried plums into one's diet is simple and doesn't involve medication, making it an appealing option for those looking for natural alternatives. This unique approach could provide a convenient and tasty way to support postmenopausal health without the need for traditional medications.

What evidence suggests that dried plums might be an effective treatment for postmenopausal bone health?

This trial will compare the effects of consuming dried plums with maintaining a regular diet on postmenopausal health. Studies have shown that eating prunes daily can strengthen bones in postmenopausal women. One study found that consuming 50 grams of prunes each day can prevent hip bone loss over 6 to 12 months. Other research suggests that prunes might also protect bones and lower the risk of bone loss with age. The findings indicate that prunes may improve bone health by reducing inflammation, the body's response to injury or illness. These results provide promising evidence that adding prunes to the diet could support bone health in postmenopausal women. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for postmenopausal women who may have food allergies, vitamin D deficiency, or constipation. Participants will be asked to add dried plums to their diet and undergo various tests over 3-4 months. Key eligibility details are not provided.

Inclusion Criteria

12 or more consecutive months without a menstrual period

Willing to include dried plums in their daily diet and collect fecal samples at four time points

I am a woman aged between 60 and 75.

Exclusion Criteria

Women who regularly consume dried plums or prune juice (>1 serving weekly)

I have not taken drugs affecting bone or calcium in the last year.

I am a woman who smokes, has a BMI over 40 or under 18.5, or drinks more than 2 alcoholic beverages daily.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants undergo baseline bone density scan, physical function assessments, and provide initial stool and blood samples

1 week

1 visit (in-person)

Treatment Arm A (Dried Plum)

Participants consume their usual diet supplemented with 50 g of dried plum per day for 4 weeks

4 weeks

2 visits (in-person)

Washout Period

Participants undergo a washout period between treatment arms

2-4 weeks

Treatment Arm B (Regular Diet)

Participants consume their usual diet without dried plum supplementation for 4 weeks

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dried Plums

Trial Overview The study investigates the effects of dietary supplementation with dried plums on immune cell function, gut microbes, and how vitamin D status might influence these outcomes in postmenopausal women.

How Is the Trial Designed?

Group I: Dried Plum Experimental Treatment 1 Intervention

Participants will consume their usual diet supplemented with 50 g of dried plum (5-6 dried plums) per day.

Group II: Regular Diet Active Control 1 Intervention

Participants will consume their usual diet.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Indiana University School of Medicine

Collaborator

Trials

194

Recruited

181,000+

Purdue University

Collaborator

Trials

239

Recruited

72,200+

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 ... 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 ...

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. 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.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07120997

Prunes Preventing Bone Loss in Perimenopause At Penn State University, the study will compare the effects of 18 months of daily dietary consumption of 50 g of prunes (5-6) versus a no-prune control group ...

6. mdpi.com mdpi.com/2072-6643/9/4/401

Dried Plums, Prunes and Bone Health: A Comprehensive ... While the data are not completely consistent, this review suggests that postmenopausal women may safely consume dried plums as part of their fruit intake ...