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RASPBERRY: Molecular Mechanisms of Raspberries Effect on Insulin Resistance and Inflammation

Sponsor
Pennington Biomedical Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT04306406
Collaborator
National Processed Raspberry Council (Other), Louisiana State University and A&M College (Other)
9
Enrollment
1
Arm
24.2
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Raspberries
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Molecular Mechanisms Underlying the Protective Effects of Whole Red Raspberries Against Insulin Resistance and Inflammation in Type 2 Diabetes
Actual Study Start Date :
Jan 7, 2015
Actual Primary Completion Date :
Jan 13, 2017
Actual Study Completion Date :
Jan 13, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) [2 weeks]

    Ratio of fasting insulin and glucose

  2. A high-sensitivity C-reactive protein (hs-CRP) measured in milligrams per liter [2 weeks]

    Measure of systemic inflammation

Secondary Outcome Measures

  1. 3,4-Dihydroxyphenylacetic acid (DOPAC) measured in nanograms per milliliter [2 weeks]

    Measure of systemic inflammation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Pennington Biomedical Research Center
  • National Processed Raspberry Council
  • Louisiana State University and A&M College

Investigators

  • Principal Investigator: Frank L Greenway, MD, Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Frank Greenway, Professor; Chief Medical Officer, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT04306406
Other Study ID Numbers:
  • 2015-0004
First Posted:
Mar 12, 2020
Last Update Posted:
Mar 12, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Insulin Resistance
Inflammation

Study Results

No Results Posted as of Mar 12, 2020