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Molecular Mechanisms of Raspberries Effect on Insulin Resistance and Inflammation (RASPBERRY)

Primary Purpose

Inflammation, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Raspberries
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • type 2 diabetes

Exclusion Criteria:

  • hypoglycemic agents
  • Pregnant or nursing a child
  • chronic medication that does not have a stable dose for greater than one month
  • anti-inflammatory medication
  • inflammatory disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Raspberry Smoothies

    Arm Description

    Single serving smoothies drink made with red raspberries to be consumed daily for two weeks

    Outcomes

    Primary Outcome Measures

    Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
    Ratio of fasting insulin and glucose
    A high-sensitivity C-reactive protein (hs-CRP) measured in milligrams per liter
    Measure of systemic inflammation

    Secondary Outcome Measures

    3,4-Dihydroxyphenylacetic acid (DOPAC) measured in nanograms per milliliter
    Measure of systemic inflammation

    Full Information

    First Posted
    July 30, 2019
    Last Updated
    March 10, 2020
    Sponsor
    Pennington Biomedical Research Center
    Collaborators
    National Processed Raspberry Council, Louisiana State University and A&M College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04306406
    Brief Title
    Molecular Mechanisms of Raspberries Effect on Insulin Resistance and Inflammation
    Acronym
    RASPBERRY
    Official Title
    Molecular Mechanisms Underlying the Protective Effects of Whole Red Raspberries Against Insulin Resistance and Inflammation in Type 2 Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 7, 2015 (Actual)
    Primary Completion Date
    January 13, 2017 (Actual)
    Study Completion Date
    January 13, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pennington Biomedical Research Center
    Collaborators
    National Processed Raspberry Council, Louisiana State University and A&M College

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Red raspberries (Rubus idaeus) are a good source of health enhancing hydrolyzable and condensed tannins, flavonoids, anthocyanins, phenolic acids, rheosmin, potassium, carotenoids, vitamin C, and vitamin K1. Compared to other berries commonly consumed in the US, the health benefits of red raspberries to improve pre-diabetes mellitus (PDM) and type 2 diabetes have never been explored. The clinical study proposed in this project seeks to investigate the protective effect of whole red raspberries against insulin resistance, oxidative stress, and inflammation in PDM and type 2 diabetic patients. The in vitro study proposed in the project will assist in identifying the molecular mechanisms by which whole red raspberry protect islet cells against oxidative stress, insulin resistance and loss of cell function.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammation, Insulin Resistance

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Raspberry Smoothies
    Arm Type
    Other
    Arm Description
    Single serving smoothies drink made with red raspberries to be consumed daily for two weeks
    Intervention Type
    Other
    Intervention Name(s)
    Raspberries
    Intervention Description
    Red raspberry smoothies drink
    Primary Outcome Measure Information:
    Title
    Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
    Description
    Ratio of fasting insulin and glucose
    Time Frame
    2 weeks
    Title
    A high-sensitivity C-reactive protein (hs-CRP) measured in milligrams per liter
    Description
    Measure of systemic inflammation
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    3,4-Dihydroxyphenylacetic acid (DOPAC) measured in nanograms per milliliter
    Description
    Measure of systemic inflammation
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: type 2 diabetes Exclusion Criteria: hypoglycemic agents Pregnant or nursing a child chronic medication that does not have a stable dose for greater than one month anti-inflammatory medication inflammatory disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frank L Greenway, MD
    Organizational Affiliation
    Pennington Biomedical Research Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Excel spreadsheets containing clinical trial data can be made available to other researchers after publication of research results.
    IPD Sharing Time Frame
    Data will become available after publication of research results.
    IPD Sharing Access Criteria
    Academic researcher

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