Molecular Mechanisms of Raspberries Effect on Insulin Resistance and Inflammation

Not Applicable

Completed

• Conditions: Insulin Resistance; Inflammation
• Interventions: Other: Raspberries

• Registration Number: NCT04306406
• Lead Sponsor: Pennington Biomedical Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-07
• Primary Completion: 2017-01-13
• Study Completion: 2017-01-13
• Study First Submitted: 2019-07-30
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-10
• Last Update Submitted: 2020-03-10
• Study First Posted: 2020-03-12
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Raspberry Smoothies	Raspberries	Single serving smoothies drink made with red raspberries to be consumed daily for two weeks

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
3,4-Dihydroxyphenylacetic acid (DOPAC) measured in nanograms per milliliter	2 weeks	Measure of systemic inflammation