Molecular Mechanisms of Raspberries Effect on Insulin Resistance and Inflammation

Inflammation Clinical Trial

— RASPBERRY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04306406
• Other study ID #: 2015-0004
• Status: Completed
• Phase: N/A
• Start date: January 7, 2015
• Est. completion date: January 13, 2017

Study information

• Verified date: March 2020
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 13, 2017
• Est. primary completion date: January 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Insulin Resistance

Intervention

Other:
• Raspberries
Red raspberry smoothies drink

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Louisiana State University and A&M College, National Processed Raspberry Council

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	Ratio of fasting insulin and glucose	2 weeks
Primary	A high-sensitivity C-reactive protein (hs-CRP) measured in milligrams per liter	Measure of systemic inflammation	2 weeks
Secondary	3,4-Dihydroxyphenylacetic acid (DOPAC) measured in nanograms per milliliter	Measure of systemic inflammation	2 weeks