Molecular Mechanisms of Raspberries Effect on Insulin Resistance and Inflammation
RASPBERRY
Molecular Mechanisms Underlying the Protective Effects of Whole Red Raspberries Against Insulin Resistance and Inflammation in Type 2 Diabetes
1 other identifier
interventional
9
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2017
CompletedFirst Submitted
Initial submission to the registry
July 30, 2019
CompletedFirst Posted
Study publicly available on registry
March 12, 2020
CompletedMarch 12, 2020
March 1, 2020
2 years
July 30, 2019
March 10, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Ratio of fasting insulin and glucose
2 weeks
A high-sensitivity C-reactive protein (hs-CRP) measured in milligrams per liter
Measure of systemic inflammation
2 weeks
Secondary Outcomes (1)
3,4-Dihydroxyphenylacetic acid (DOPAC) measured in nanograms per milliliter
2 weeks
Study Arms (1)
Raspberry Smoothies
OTHERSingle serving smoothies drink made with red raspberries to be consumed daily for two weeks
Interventions
Eligibility Criteria
You may qualify if:
- type 2 diabetes
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank L Greenway, MD
Pennington Biomedical Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor; Chief Medical Officer
Study Record Dates
First Submitted
July 30, 2019
First Posted
March 12, 2020
Study Start
January 7, 2015
Primary Completion
January 13, 2017
Study Completion
January 13, 2017
Last Updated
March 12, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data will become available after publication of research results.
- Access Criteria
- Academic researcher
Excel spreadsheets containing clinical trial data can be made available to other researchers after publication of research results.