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
About this trial
This is an interventional prevention trial for Inflammation
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
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
NCT ID
NCT04306406
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
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
Learn more about this trial
Molecular Mechanisms of Raspberries Effect on Insulin Resistance and Inflammation
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