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Healthy, Postmenopausal WomenNCT02950402

Dried Plums and Chronic Disease Markers

A study testing Two Dried Plums per day and Six Dried Plums per day in people with Healthy, Postmenopausal Women, run by University of California, Davis.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates whether the consumption of California dried plums can be beneficial to your health. Previous studies using dried plums have shown beneficial effects on bone and cardiovascular health. Read more about this study

Who is it for?
Ages 50 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy, Postmenopausal Women
What is being tested?
Two Dried Plums per day and Six Dried Plums per day
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
No sites listed yet
Study dates
Jun 2016to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 50 to 70 years of age
  • Lack of menses in the last year and FSH 23-116.3 mlU/mL
  • Subject is willing and able to comply with the study protocols.
  • Subject is willing participate in all study procedures
  • BMI 18.5 - 34.9 kg/m2
  • Weight ≥ 110 pounds

Who cannot join

  • BMI < 18.5 kg/m2
  • BMI ≥ 35 kg/m2
  • Dislike or allergy for dried plums
  • Self-reported use of daily anticoagulation agents including aspirin, NSAIDs
  • Self-reported use of oral cortisone or other immunosuppressive agents,
  • Self-reported underlying neoplasia or immunological disease
Show all 37Show fewer
  • Vegan, Vegetarians, food faddists or those consuming a non-traditional diet • Alcohol consumption > 3 drinks/week (i.e. 1 bottle of beer, ½ glass of wine, and 1 shot of hard liquor)
  • Fruit consumption ≥ 2 cups/day
  • Vegetable consumption ≥ 3 cups/day for females
  • Fatty Fish ≥ 3 times/week
  • Coffee/tea ≥ 3 cups/day
  • Dark chocolate ≥ 3 oz/day
  • Self-reported restriction of physical activity due to a chronic health condition
  • Self-reported chronic/routine high intensity exercise
  • Self-reported diabetes
  • Blood pressure ≥ 140/90 mm Hg
  • Self-reported renal or liver disease
  • Self-reported heart disease, which includes cardiovascular events and Stroke
  • Self-reported Cushing's syndrome
  • Self-reported chronic/routine high intensity exercise
  • Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT
  • Abnormal Liver, CBC or Chemistry panels (laboratory values outside the reference range) if determined to be clinically significant by the study physician.
  • Self-reported cancer within past 5 years
  • Self-reported malabsorption
  • Currently taking prescription drugs or supplements.
  • Use of multi-vitamin and mineral other than a general formula of vitamins and minerals that meet the RDA
  • Not willing to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements a month prior to study enrollment.
  • Indications of substance or alcohol abuse within the last 3 years
  • Screening LDL ≥ 190 mg/dl for those who have 0-1 major risk factors apart from LDL cholesterol (i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL].
  • Screening LDL ≥ 160 mg/dl for those who have 2 major risk factors apart from LDL cholesterol [i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL].
  • (using NCEP calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp);
  • Screening LDL ≥ 130 mg/dl for those who have 2 major risk factors apart from LDL cholesterol [i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL], and a Framingham 10-year Risk Score 10-20% (using NCEP calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp).
  • Current enrollee in a clinical research study.
  • The following special populations will be excluded:
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

About this study

Official title: Impact of California Dried Plums on Markers of Bone, Cardiovascular and Digestive Health

This study evaluates whether the consumption of California dried plums can be beneficial to your health. Previous studies using dried plums have shown beneficial effects on bone and cardiovascular health. In addition the investigators hope to learn how dried plums might change your bowel habits, and if the carbohydrates in the plums are fermented in your digestive tract.

Read the detailed description

The aging of the U.S. population presents a number of challenges, many of which that can be addressed through nutritional approaches. Postmenopausal women are particularly at-risk for a number of diseases such as osteoporosis (By 2020 it is estimated that 50 percent of women at 50 years and older will either suffer from or be at-risk of bone loss), and cardiovascular disease, the number one killer of postmenopausal women. Polyphenolic compounds in fruits and nuts have been the focus of extensive research regarding their potential to reduce risk for a number of chronic diseases. All fruits are not created equally, so determining if dried plums (Prunus domestica L.) have certain phytochemicals in amounts that promote health when consumed in realistic amounts is important. This demonstration is likely to impact market demand for dried plums. Indeed, favorable research on other California specialty crops (walnuts, almonds, strawberries, grapes) is a key strategy to help growers increase sales.

While hundreds of plum cultivars exist, with varying amounts of phenolic compounds, the process of drying results in high amounts on hydroxycinnamic acids, a family of compounds that have been shown, in animal models, to be protective of bone health by both reducing bone loss and improving bone growth. Hydroxycinnamic acids have also been proposed to improve vascular function by protecting the smooth endothelial lining of the blood vessels in animal models. Whether these encouraging observations also occur in humans is unknown. Therefore, the overall objective of this project is to conduct the first human study exploring the effects of California dried plums on markers of bone health and vascular function. Favorable results from this project will increase awareness of the unique benefits of dried plums for bone health and vascular health, two topics of great interest to aging baby boomers and other health-conscious consumers, both in the U.S. and internationally.

Being tested
Two Dried Plums per day, Six Dried Plums per day

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Two Dried Plums per dayOther

    Subjects will consume Two Dried Plums per day

  • Six Dried Plums per dayOther

    Subjects will consume Six Dried Plums per day

Study groups in NCT02950402
Study groupRoleWhat they receive
Two Dried Plums per dayExperimentalTwo Dried Plums per day is approximately 14 g.
Receives: Other: Two Dried Plums per day; Other: Six Dried Plums per day
Six Dried Plums per dayExperimentalSix Dried Plums per day is approximately 42 g.
Receives: Other: Two Dried Plums per day; Other: Six Dried Plums per day

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. C-telopeptide, beta-cross-linked (CTX), a marker of bone resorption

    To determine whether short-term (two weeks) intake of California dried plums will improve markers of bone health, as measured by a serum marker of bone remodeling called C-telopeptide, beta-cross-linked (CTX)

    Measured: Change measures ("baseline and 2 weeks")

Secondary outcomes (5)

  1. Peripheral artery tonometry (PAT), a vascular function measure

    To determine whether short-term (two weeks) intake of California dried plums will improve vascular function, as measured using peripheral artery tonometry (PAT).

    Measured: Change measures ("baseline and 2 weeks")

  2. Breath hydrogen

    To determine the extent in which dried plum intake changes colonic fermentation products in dried plums.

    Measured: Change measures ("baseline and 2 weeks")

  3. Complete metabolic panel

    Blood analyses will include measurements of complete blood cell count, comprehensive metabolic panel, and lipid profile.

    Measured: Change measures ("baseline and 2 weeks")

  4. Body weight

    Body weight will be recorded at baseline and after two weeks of dried plum intake.

    Measured: Change measures ("baseline and 2 weeks")

  5. Blood pressure

    The baseline office blood pressure measurement will be obtained (3 measurements 5 minutes apart after a 15 minute rest).

    Measured: Change measures ("baseline and 2 weeks")

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02950402
Sponsor's protocol ID
843989
Status last verified
Mar 2018
First submitted
28 Oct 2016
Last updated
22 Mar 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Two Dried Plums per day and Six Dried Plums per day in people with Healthy, Postmenopausal Women, run by University of California, Davis.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

C-telopeptide, beta-cross-linked (CTX), a marker of bone resorption (time frame: Change measures ("baseline and 2 weeks")). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02950402.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.

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