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

March 10, 2020 updated by: Frank Greenway, Pennington Biomedical Research Center

Molecular Mechanisms Underlying the Protective Effects of Whole Red Raspberries Against Insulin Resistance and Inflammation in Type 2 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

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

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Raspberry Smoothies
Single serving smoothies drink made with red raspberries to be consumed daily for two weeks
Other: Raspberries
Red raspberry smoothies drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time Frame: 2 weeks
Ratio of fasting insulin and glucose
2 weeks
A high-sensitivity C-reactive protein (hs-CRP) measured in milligrams per liter
Time Frame: 2 weeks
Measure of systemic inflammation
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3,4-Dihydroxyphenylacetic acid (DOPAC) measured in nanograms per milliliter
Time Frame: 2 weeks
Measure of systemic inflammation
2 weeks

Collaborators and Investigators

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

Sponsor

Pennington Biomedical Research Center

Collaborators

Louisiana State University and A&M College
National Processed Raspberry Council

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)

January 7, 2015

Primary Completion (Actual)

January 13, 2017

Study Completion (Actual)

January 13, 2017

Study Registration Dates

First Submitted

July 30, 2019

First Submitted That Met QC Criteria

March 10, 2020

First Posted (Actual)

March 12, 2020

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

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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