Dried Plums and Bone Health in Postmenopausal Women

NCT02822378 | Active Not Recruiting DMC

• 1 other identifier: Study00004252
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Osteoporosis

Keywords

Postmenopausal Osteoporosis; Human; Female; Non-pharmacologic therapy

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in areal bone mineral density (via DXA) of the lumbar spine, total hip, and femoral neck

  Percent change in areal BMD measured during screening, and weeks 24 and 52 of the 52 week dietary intervention at the lumbar spine, total hip, and femoral neck.

  at screening, week 24, and week 52

Secondary Outcomes (6)

• Percent change from baseline in DXA hip structural analysis

  at screening, week 24, and week 52

• Percent change from baseline in DXA spine trabecular bone score

  at screening, week 24, and week 52

• Percent change from baseline in pQCT volumetric BMD of the tibia and radius

  at baseline, week 24, and week 52

• Percent change from baseline in pQCT geometry measurements of the tibia and radius

  at baseline, week 24, and week 52

• Percent change from baseline in pQCT strength measurements of the tibia and radius

  at baseline, week 24, and week 52

Other Outcomes (5)

• Change from baseline in cellular bone metabolism

  at baseline, week 12, week 24, week 36, and week 52

• Change from baseline in urine phenolic concentrations

  at baseline and every 4 weeks during the intervention

• Change from baseline in serum phenolic concentrations

  at baseline, week 12, week 24, week 36, and week 52

Study Arms (3)

Ca2+/VitD Control

EXPERIMENTAL

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).

Dietary Supplement: Calcium supplement; Dietary Supplement: Vitamin D supplement

50g Dried Plums

EXPERIMENTAL

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).

Dietary Supplement: Dried Plum; Dietary Supplement: Calcium supplement; Dietary Supplement: Vitamin D supplement

100g Dried Plums

EXPERIMENTAL

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).

Dietary Supplement: Dried Plum; Dietary Supplement: Calcium supplement; Dietary Supplement: Vitamin D supplement

Interventions

Dried Plum 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.

Also known as: Prunes

100g Dried Plums; 50g Dried Plums

Calcium supplement DIETARY_SUPPLEMENT

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

100g Dried Plums; 50g Dried Plums; Ca2+/VitD Control

Vitamin D supplement DIETARY_SUPPLEMENT

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

100g Dried Plums; 50g Dried Plums; Ca2+/VitD Control

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Penn State University: lead
• California Dried Plum Board: collaborator

Study Sites (1)

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

University Park, Pennsylvania, 16802, United States

Location

Related Publications (3)

• 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.

  PMID: 38490532 DERIVED

• 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.

  PMID: 37984741 DERIVED

• 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.

  PMID: 35798020 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mary Jane De Souza, PhD

  The Pennsylvania State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Kinesiology and Physiology

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: July 4, 2016
• Study Start: June 1, 2016
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)