Dried Plums and Bone Health in Postmenopausal Women

NCT ID: NCT02822378

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 322 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

Detailed Description

Given the current high incidence of osteoporosis, reducing the risk of osteoporosis development is essential. Recent estimates, based on the 2010 US Census, indicate that approximately 10.3 million people age 50 and older have osteoporosis. By 2030 the prevalence of osteoporosis for women 50 years and older is projected to reach 13.6 million. Postmenopausal osteoporosis is characterized not only by hypoestrogenism, but also by increased production of reactive oxygen species, oxidative stress, and inflammatory response. Current first line strategies are treatment of osteoporosis with pharmacologic approaches. Complementary recommendations include the maintenance of calcium (Ca2+) and vitamin D (VitD) intake to meet the current recommendations. Although the anti-resorptive therapies are effective they are also associated with an array of negative side effects, which reduce patient compliance to use of the therapy.

Non-pharmacologic options to reducing the risk of bone loss are becoming more attractive to many postmenopausal women. The phenolics and bioavailable conjugated metabolites found in dried plums are proposed to modulate the inflammatory signaling pathways and have the potential to influence bone formation and bone resorption, thus modulating the risk of bone loss. The investigators are conducting a 52 week dose ranging randomized controlled trial that builds upon previous rodent and human work and addresses the experimental design limitations of the previous work, to assess bone outcomes with clinical (BMD) and mechanistic (bone geometry, bone metabolism markers, and inflammation markers) techniques. Additionally, this study will include a detailed assessment of the phenolics in the dried plums to explore the relationship between these compounds and bone outcomes.

Participants will participate in a 1-2 week screening period followed by a 1-2 week baseline period. At the end of baseline randomization to 1 of 3 groups will occur (Ca2+ and VitD only; 50g Dried Plums/day and Ca2+ and VitD; 100g Dried Plums/day and Ca2+ and VitD). Dried plums and Calcium/Vitamin D supplements will be provided to participants for the duration of the intervention. At the beginning of the 52 week intervention participants will begin consumption of dried plums and will be given a run in period where the number of dried plums consumed per day increases slowly to minimize the side effects felt by the participants. The dried plums will be consumed as snacks in the morning, midday, and in the evening. Participants will visit the laboratory for testing every 4 weeks during the 52 week intervention, with more testing occurring during weeks 12, 24, 36, and 52 than the other testing periods.

At testing period visits participants will be asked to complete some or all of the following: body weight measurement; blood sampling; 24-hour urine collection; stool sample collection; DXA scan; peripheral quantitative computed tomography (pQCT) scan; completion of health, physical activity, and nutrition questionnaires; completion of supplement/symptom, diet, and physical activity logs.

A total of 300 participants will be enrolled and screed with an expected randomization of 79 participants per group. The investigators anticipate a 20% drop-out rate between baseline and week 52, thus will anticipate having a final sample size of 63 participants per group complete the study. This sample size provides over 80% power to detect differences with the primary BMD, bone geometry, and bone strength variables.

Conditions

Postmenopausal Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Ca2+/VitD Control

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 Type: EXPERIMENTAL

Calcium supplement

Intervention Type: DIETARY_SUPPLEMENT

All participants will consume calcium supplements for the duration of baseline and intervention.

Vitamin D supplement

Intervention Type: DIETARY_SUPPLEMENT

All participants will consume vitamin D supplements for the duration of baseline and intervention.

50g Dried Plums

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 Type: EXPERIMENTAL

Dried Plum

Intervention Type: DIETARY_SUPPLEMENT

Participants randomized to the 50g dried plum group will consume 6 dried plums per day for the duration of the 52 week intervention. Participants randomized to the 100g dried plum group will consume 12 dried plums per day for the duration of the 52 week intervention.

Calcium supplement

Intervention Type: DIETARY_SUPPLEMENT

All participants will consume calcium supplements for the duration of baseline and intervention.

Vitamin D supplement

Intervention Type: DIETARY_SUPPLEMENT

All participants will consume vitamin D supplements for the duration of baseline and intervention.

100g Dried Plums

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).

Group Type: EXPERIMENTAL

Dried Plum

Intervention Type: DIETARY_SUPPLEMENT

Participants randomized to the 50g dried plum group will consume 6 dried plums per day for the duration of the 52 week intervention. Participants randomized to the 100g dried plum group will consume 12 dried plums per day for the duration of the 52 week intervention.

Calcium supplement

Intervention Type: DIETARY_SUPPLEMENT

All participants will consume calcium supplements for the duration of baseline and intervention.

Vitamin D supplement

Intervention Type: DIETARY_SUPPLEMENT

All participants will consume vitamin D supplements for the duration of baseline and intervention.

Interventions

Dried Plum

Participants randomized to the 50g dried plum group will consume 6 dried plums per day for the duration of the 52 week intervention. Participants randomized to the 100g dried plum group will consume 12 dried plums per day for the duration of the 52 week intervention.

Intervention Type: DIETARY_SUPPLEMENT

Calcium supplement

All participants will consume calcium supplements for the duration of baseline and intervention.

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D supplement

All participants will consume vitamin D supplements for the duration of baseline and intervention.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Prunes

Eligibility Criteria

Inclusion Criteria

• Postmenopausal women
• not severely obese (BMI < 40 kg/m2);
• healthy (determined by a screening questionnaire, complete metabolic panel);
• willing to include dried plums in their daily diet;
• not taking any natural dietary supplement containing phenolics, blueberries or apples for at least 2 months prior to study entry; can stop for 2 months to meet entry criteria
• non-smoking; ambulatory;
• low BMD as measured by dual energy X-ray absorptiometry (DXA). Eligible BMD values (T-scores) for DXA measures of the lumbar spine, total hip and/or femoral neck will correspond to T-scores between 0 and -3.0.

Exclusion Criteria

• Women who regularly consume dried plums, dried apples, prune juice, or heavy consumers of blueberries (1 cup or more/day). Potential volunteers who will refrain from consumption of the afore mentioned foods for the duration of the study will become eligible after a 2 month washout period;
• vitamin D deficiency (<20 ng/mL);
• history of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis after age 50 yr);
• untreated hyper- or hypothyroidism;
• current hyper- or hypoparathyroidism;
• significantly impaired renal function; high potassium
• current hypo- or hypercalcemia;
• history of spinal stenosis;
• history of heart attack, stroke, thromboembolism, kidney disease, malabsorption syndrome, seizure disorders;
• positive for HIV, Hep-C or Hep-B surface antigen and malignancy.
• Use of the following agents affecting bone metabolism:

• intravenous bisphosphonates at any time;
• fluoride (for osteoporosis) within the past 24 months;
• denosumab at any time;
• bisphosphonates, parathyroid hormone or strontium within the past 12 months;
• calcitonin or selective estrogen receptor modulators within the past 12 months;
• systemic oral or transdermal estrogen within the past 3 months;
• systemic glucocorticosteroids (≥ 5 mg prednisone equivalent per day for more than 10 days); or
• tibolone within the past 3 months.
• Participants who will not consume study therapy or will not stop taking natural product supplements of their own selection.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

California Dried Plum Board

OTHER

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Mary Jane DeSouza

Professor of Kinesiology and Physiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Jane De Souza, PhD

Role: PRINCIPAL_INVESTIGATOR

The Pennsylvania State University

Locations

Women's Health and Exercise Laboratories, The Pennsylvania State University

University Park, Pennsylvania, United States

Countries

United States

References

Damani JJ, Rogers CJ, Lee H, Strock NC, Koltun KJ, Williams NI, Weaver C, Ferruzzi MG, Nakatsu CH, De Souza MJ. Effects of Prune (Dried Plum) Supplementation on Cardiometabolic Health in Postmenopausal Women: An Ancillary Analysis of a 12-Month Randomized Controlled Trial, The Prune Study. J Nutr. 2024 May;154(5):1604-1618. doi: 10.1016/j.tjnut.2024.03.012. Epub 2024 Mar 13.

Reference Type: DERIVED

PMID: 38490532 (View on PubMed)

Damani JJ, Oh ES, De Souza MJ, Strock NC, Williams NI, Nakatsu CH, Lee H, Weaver C, Rogers CJ. Prune Consumption Attenuates Proinflammatory Cytokine Secretion and Alters Monocyte Activation in Postmenopausal Women: Secondary Outcome Analysis of a 12-Mo Randomized Controlled Trial: The Prune Study. J Nutr. 2024 May;154(5):1699-1710. doi: 10.1016/j.tjnut.2023.11.014. Epub 2023 Nov 19.

Reference Type: DERIVED

PMID: 37984741 (View on PubMed)

De Souza MJ, Strock NCA, Williams NI, Lee H, Koltun KJ, Rogers C, Ferruzzi MG, Nakatsu CH, Weaver C. Prunes preserve hip bone mineral density in a 12-month randomized controlled trial in postmenopausal women: the Prune Study. Am J Clin Nutr. 2022 Oct 6;116(4):897-910. doi: 10.1093/ajcn/nqac189.

Reference Type: DERIVED

PMID: 35798020 (View on PubMed)

Other Identifiers

Study00004252

Identifier Type: -

Identifier Source: org_study_id