Status:
COMPLETED
Impact of Aronia Berry Consumption on Inflammation, Metabolites, and the Gut Microbiome
Lead Sponsor:
Montana State University
Conditions:
Inflammation
Metabolic Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The goal of this project is to elucidate interactions between the gut microbiome, anti-inflammatory/anti-oxidant food metabolomic signatures, and human inflammation phenotypes. Inflammation plays both...
Detailed Description
To meet these objectives, a randomized, double-blind, placebo-controlled clinical trial of Aronia versus placebo treatment for 28-30 days in human adults will be conducted. Pre- and post-intervention ...
Eligibility Criteria
Inclusion
- \- 18-60 years
Exclusion
- Individuals who are pregnant or have other health conditions that might make it difficult to participate in the study, including heart disease, diabetes, and hypertension
- Individuals who are unwilling or unable to complete multiple venipuncture collections.
- Individuals who have food allergies or sensitivities to berry fruits
- Individuals unwilling or unable to avoid foods on provided food list for the duration of the supplementation period.
- Individuals who have food allergies or dietary restrictions to any of the foods being used, including wheat, dairy, or Aronia berries (chokeberries)
- Individuals taking blood pressure, lipid-lowering, or anti-inflammatory medications
- Individuals who have taken antibiotics in previous 90 days
- Individuals who have food allergy or intolerance to red food dye
Key Trial Info
Start Date :
April 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05255718
Start Date
April 27 2019
End Date
August 18 2019
Last Update
March 13 2024
Active Locations (1)
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1
Nutrition Research Laboratory
Bozeman, Montana, United States, 59717