Molecular Mechanisms of Raspberries Effect on Insulin Resistance and Inflammation

NCT ID: NCT04306406

Last Updated: 2020-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-07

Study Completion Date

2017-01-13

Brief Summary

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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

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Conditions

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Inflammation Insulin Resistance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Raspberry Smoothies

Single serving smoothies drink made with red raspberries to be consumed daily for two weeks

Group Type OTHER

Raspberries

Intervention Type OTHER

Red raspberry smoothies drink

Interventions

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Raspberries

Red raspberry smoothies drink

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Processed Raspberry Council

UNKNOWN

Sponsor Role collaborator

Louisiana State University and A&M College

OTHER

Sponsor Role collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Frank Greenway

Professor; Chief Medical Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank L Greenway, MD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Other Identifiers

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2015-0004

Identifier Type: -

Identifier Source: org_study_id

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