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

322 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Postmenopausal women often seek non-pharmacologic interventions for the protection of bone health. Previous research in humans and rodents has indicated that dietary dried plum consumption may be beneficial for bone health, especially in postmenopausal women. However, it is unknown in what quantity dried plums need to be consumed to be of benefit and through what mechanisms dried plums act to impact bone health. Therefore, the purpose of this study is to evaluate the impact of 52 weeks of dried plums consumption in varying quantities on bone mineral density (BMD), bone geometry, and estimated bone strength in postmenopausal women. The investigators also seek to evaluate the mechanisms underlying the effects of dried plums as a dietary supplement by assessing polyphenols and the bioavailable conjugated metabolites in the urine of postmenopausal women taking different doses of dietary dried plums. The investigators aim to further investigate the mechanisms of dried plum action on bone by measuring markers of bone metabolism in response to dried plum consumption.

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+