Dried Plum Supplementation as Treatment for Bone Loss Following Spinal Cord Injury

October 18, 2021 updated by: Beatrice Jenny Kiratli PhD, VA Palo Alto Health Care System
The purpose of this pilot study is to explore whether dried plum (prunes) added to the diet is effective in reducing or reversing bone loss following spinal cord injury (SCI). The investigators will look for changes in bone mineral density as well as evidence in the blood of markers of bone activity. The first part of the study is to check whether participants with SCI can and will eat the required amount of dried plums (prunes) on a daily basis. The second part of the study is to follow participants over one year and look for changes in bone mass and blood markers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Recruitment & screening: SCI clinicians will invite patients from the VA SCI Center census to participate in the pilot in person during a clinic visit or inpatient admission. If the patient is interested, one of the study team will explain the study and obtain consent. The study will be performed on an outpatient basis with return to the VA for study visits at 3, 6 ,9 , and 12 months.

The investigators will mail Opt-Out Letters to individuals who have been identified as potentially eligible. The Opt-Out Letter will include a Response Letter and a Return Self-addressed Stamped Envelope (attached). If the investigators do not receive a NO response by phone or mail after 2 weeks, they will attempt to call using an Opt-Out Telephone Script and Recruitment Script (Attached).

Screening is primarily done based on interest, medical history and contraindications. There may be blood values, collected at baseline that indicate ineligibility, but these will be determined on individual cases. Interest in the study and commitment to maintain the study diet/intake will be important to ascertain - although the investigators anticipate that there may be dropout or reduced compliance with time.

Procedures:

  1. For the first month, each participant will consume 6-8 prunes per day to determine tolerability. Starting in Month 2, each participant will consume approximately 10-16 prunes/day (<120 g), depending on the size of the prune. The smaller prunes weigh about 7 g and the larger weigh up to 10 g. It will be suggested to consume 5-8 prunes twice per day for breakfast and dinner. However, this is not a requirement, so long as the per-day goal is met. If a participant does not eat the daily requirement one day they will be encouraged to make up the difference over the next 6 days such that the total is equal to the required 100-112 total prunes for the week. If however, they miss multiple days of prune consumption, they will be asked to contact the study coordinators to develop a reasonable plan to get back on track.
  2. Participants will be asked to track consumption regularly by use of a chart. They will be instructed to note days when they missed or consumed fewer prunes. They will also be instructed to note any changes in bowel or other function and contact study staff with any questions.

Assessments:

  1. Bone mineral density by dual xray absorptiometry (DXA) to include the following sites: total body, spine, bilateral hip, bilateral knee. Total body scans will be obtained at baseline and at 12 months; all other scans will be obtained at baseline, 3, 6, 9, and 12 months.
  2. Blood assessments will be collected at the same intervals and will include serum concentrations of C-terminal telopeptide (CTX), which is a bone resorption marker, and Procollagen Type I Intact N-Terminal Propeptide (P1NP), a bone formation marker to measure the rate and direction of bone metabolism during the study. Serum will be frozen for batch processing. Safety labs will also be drawn including a comprehensive metabolic panel, primarily to monitor renal function, calcium concentration, and blood sugar. Magnesium and phosphorus levels will also be analyzed. De-identified, coded blood samples will be sent to Quest Diagnostics Lab (contracting lab) for analysis.
  3. Surveys will be administered to the participants at 0, 3, 6, 9, and 12 months. These will include the Global Health Scale- to evaluate overall health and well-being, the Spinal Cord Injury Quality of Life Questionnaire (SCI-QOL) on Bowel Management as well as the Bristol Stool Chart-to ascertain any affects the consumption of prunes have on participants' bowel habits. Finally participants will be given a brief questionnaire regarding their activity level, general health status, lifestyle habits, and participation characteristics while in the study.

Study Contact: For the first month, study staff will call each participant weekly to ask about any concerns or issues related to prune consumption. After this, calls will be less frequent, biweekly for the next month(s) and once per month after this. As this is a pilot study, the investigators may adjust the call frequency as needed to determine if more or fewer calls are needed. One of the main goals of this pilot is to determine feasibility related to regular consumption; the investigators feel that useful information can be gathered by calling rather than waiting for the participant to contact us.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • VA Palo Alto Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • SCI at any level, America Spinal injury Association (ASIA) Impairment Scale = A-C
  • Primarily wheelchair-user
  • Age - between 18 and 65 years old.

  • Two cohorts will be recruited:

    1. chronic injury greater than 4 yr and
    2. newly injured, less than 4 years
  • The investigators will target Vit D blood level to be 20 ng/ml or higher and suggest that any potential participants with Vit D greater than 10 but below 20 receive a clinical protocol to achieve 20 ng/ml.

Exclusion Criteria:

  • Presence of hyper/hypo-parathyroidism, renal insufficiency (GFR<60ml/min), currently taking hormone replacement therapy, severe vitamin D deficiency (<10 ng/ml), thyroid disease, active cancer diagnosis, currently using bisphosphonate or parathyroid hormone therapy, diagnosed fracture less than 3 months ago, current pressure sore stage III or IV, New York Heart Association (NYHA) functional classification of stage II-IV, inflammatory bowel disease, cirrhosis of the liver, consuming more than 3 dried plums/day as their regular diet.
  • Vitamin D blood level below 10 ng/ml

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Dried Plums
Consume dried plums daily.
Dietary supplement: Dried plums
10-16 dried plums/day, approximately 100-120 g/day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Procollagen Type I Intact N-Terminal Propeptide (P1NP)
Time Frame: change from baseline to 12 months
Blood marker of bone formation
change from baseline to 12 months
Change in C-terminal telopeptide (CTX)
Time Frame: change from baseline to 12 months
Blood marker of bone resorption
change from baseline to 12 months
Change in Bone mineral density (BMD) - multiple sites
Time Frame: change from baseline to 12 months
BMD of hip and knee
change from baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Palo Alto Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KIB0033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

This is very preliminary and we are not sure yet if sharing will be valuable as we may make protocol amendments depending on study data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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