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OpenTrials
Completed

NCT Number: NCT04306406

Molecular Mechanisms of Raspberries Effect on Insulin Resistance and Inflammation

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Raspberries

Other

Red raspberry smoothies drink

Primary outcomes

  1. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

    Time frame: 2 weeks

    Ratio of fasting insulin and glucose

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

    Time frame: 2 weeks

    Measure of systemic inflammation

Secondary outcomes

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

    Time frame: 2 weeks

    Measure of systemic inflammation

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

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

Registry information

Official study title

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

Acronym: RASPBERRY

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 12, 2020
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.