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CompletedNCT04306406RASPBERRYUpdated Mar 12, 2020

Molecular Mechanisms of Raspberries Effect on Insulin Resistance and Inflammation

An interventional study of Raspberries in Inflammation and Insulin Resistance, sponsored by Pennington Biomedical Research Center. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-03-12.

Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 6 months after the study started (first participant enrolled Jan 2015, registered Jul 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Inflammation
  • Insulin Resistance
03

In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's enrollment of 9 is below the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

Pennington Biomedical Research Center is the lead sponsor of 277 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • type 2 diabetes

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Other
    Raspberry Smoothies

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

    Other: Raspberries

Interventions

  • OtherRaspberries

    Red raspberry smoothies drink

06

What researchers measure

Primary outcomes

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

    Ratio of fasting insulin and glucose

    Time frame: 2 weeks

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

    Measure of systemic inflammation

    Time frame: 2 weeks

Secondary outcomes

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

    Measure of systemic inflammation

    Time frame: 2 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — Excel spreadsheets containing clinical trial data can be made available to other researchers after publication of research results.

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04306406
Lead sponsor
Pennington Biomedical Research Center
Collaborators
National Processed Raspberry Council, Louisiana State University and A&M College
Responsible party
Frank Greenway (Professor; Chief Medical Officer, Pennington Biomedical Research Center) — Principal investigator
First posted
Mar 12, 2020
Start date
Jan 7, 2015
Primary completion
Jan 13, 2017
Completion
Jan 13, 2017
Last update
Mar 12, 2020

Study contacts

Frank L Greenway, MD
principal investigator · Pennington Biomedical Research Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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