Health TrialsbyHealthPanel

Prunes Preventing Bone Loss in Perimenopause

ConditionPerimenopausal Bone Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age44-55
SponsorPenn State University

About this trial

Dietary interventions of prune consumption during the transmenopausal period are innovative methods to prevent bone loss. Modern medicine does not intervene to prevent or attenuate this highly vulnerable period of bone loss which, if successfully attenuated, can potentially prevent/delay osteoporosis in women. The transmenopausal period represents an opportunistic window for the study because bone loss is at its greatest at this time, with females losing as much as 6-7% of bone. If this project is successful at attenuating bone loss, it can immediately be disseminated to the public to promote prune consumption to slow down and attenuate perimenopausal bone loss. As such, this project could improve the long-term bone health of females and avoid or delay osteoporosis and improve quality of life. The long-term goal of this study is to test the novel hypothesis that prune consumption for 18 months during the 3-year transmenopausal period prevents the dramatic rate of bone loss in perimenopausal females during a window of heightened physiological vulnerability. 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 on bone outcomes (bone mineral density, bone geometry), mechanistic factors (bone and inflammatory markers, inflammatory response of ex vivo cultured peripheral blood mononuclear cells, monocytes), and gut microbiome.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 44 to 55 years

Not severely obese (BMI <35 kg/m²)

Healthy (determined by a screening questionnaire, physical and medical history by a certified nurse practitioner, complete metabolic panel, and complete blood count)

Willing to include prunes in their daily diet

Disqualifiers

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

History of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis after age 45 yr)

Untreated hyper- or hypothyroidism

Current hyper- or hypoparathyroidism

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prunes

    Dietary supplement

    Participants randomized to the 50g prune group will consume 6 prunes per day for the duration of the 18-month intervention.

  • Calcium supplement

    Dietary supplement

    All participants will consume calcium supplements daily for a baseline period and for the duration of the 18-month intervention.

  • Vitamin D Supplement

    Dietary supplement

    All participants will consume Vitamin D supplements daily for a baseline period and for the duration of the 18-month intervention.

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: Calcium and Vitamin D - Control groupExperimental treatment 2 interventions
Group B: 50g Prunes, Calcium, and Vitamin D - Intervention GroupExperimental treatment 3 interventions

Trial outcomes

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 bone mineral density measured at baseline, month 9, and month 18 of the 18-week dietary intervention at the lumbar spine, total hip, and femoral neck.

Time frame
Baseline, month 9, month 18

Secondary outcomes

1

Changes from baseline in Spine Trabecular Bone Score (TBS) (via DXA)

Changes in Spine Trabecular Bone Score (TBS) assessed at baseline, month 9, and month 18 of the 18-month dietary intervention from lumbar spine DXA scans. The measurements will provide additional information about the effects of the intervention on trabecular bone.

Time frame
Baseline, month 9, and month 18
2

Percent change from baseline in volumetric BMD of the tibia and radius (via pQCT)

Percent change in volumetric BMD, cortical and trabecular compartments, measured during baseline, month 9, and month 18 of the 18-month dietary intervention at the tibia and radius. The combination of measurements will provide an overall picture of the 3-dimensional structure of a weight bearing (tibia) and non-weight bearing (radius) site and how the sites are impacted by the intervention.

Time frame
Baseline, month 9, and month 18
3

Percent change from baseline in bone geometry measurements of the tibia and radius (via pQCT)

Percent change in bone geometry estimates (total bone area, cortical and trabecular area, cortical thickness) measured during baseline, and month 9, and month 18 of the 18-month dietary intervention at the tibia and radius. The combination of measurements will provide an overall picture of the 3-dimensional structure of a weight bearing (tibia) and non-weight bearing (radius) site and how the sites are impacted by the intervention.

Time frame
Baseline, month 9, and month 18
4

Percent change from baseline in bone strength index of the tibia and radius (via pQCT)

Percent change in bone strength index (BSI) measured during baseline, and month 9, and month 18 of the 18-month dietary intervention at the tibia and radius. The measurement will provide an overall picture of bone strength and of the 3-dimensional structure of a weight bearing (tibia) and non-weight bearing (radius) site and how the sites are impacted by the intervention.

Time frame
Baseline, month 9, and month 18

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Penn State University

Lead sponsor

University of Georgia

Collaborator

California Dried Plum Board

Collaborator

United States Department of Agriculture (USDA)

Collaborator

Source ClinicalTrials.gov
Apply now