Dried Plums and Chronic Disease Markers

NCT02950402 | Completed

• 1 other identifier: 843989
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Healthy, Postmenopausal Women

Outcome Measures

Primary Outcomes (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)

  Change measures ("baseline and 2 weeks")

Secondary Outcomes (5)

• Peripheral artery tonometry (PAT), a vascular function measure

  Change measures ("baseline and 2 weeks")

• Breath hydrogen

  Change measures ("baseline and 2 weeks")

• Complete metabolic panel

  Change measures ("baseline and 2 weeks")

• Body weight

  Change measures ("baseline and 2 weeks")

• Blood pressure

  Change measures ("baseline and 2 weeks")

Study Arms (2)

Two Dried Plums per day

EXPERIMENTAL

Two Dried Plums per day is approximately 14 g.

Other: Two Dried Plums per day; Other: Six Dried Plums per day

Six Dried Plums per day

EXPERIMENTAL

Six Dried Plums per day is approximately 42 g.

Other: Two Dried Plums per day; Other: Six Dried Plums per day

Interventions

Two Dried Plums per day OTHER

Subjects will consume Two Dried Plums per day

Six Dried Plums per day; Two Dried Plums per day

Six Dried Plums per day OTHER

Subjects will consume Six Dried Plums per day

Six Dried Plums per day; Two Dried Plums per day

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 1, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 22, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share