Status:

COMPLETED

Effect of Flavonoids on Gut Permeability in Cyclists

Lead Sponsor:

Utah State University

Conditions:

Gut Permeability, Gut Inflammation

Eligibility:

All Genders

18-49 years

Phase:

PHASE1

Brief Summary

The purpose of this investigation is to test the hypothesis that chronic supplementation with a dairy-based beverage containing a mixture of blueberry, green tea, and cocoa flavonoids (non-nutritive n...

Eligibility Criteria

Inclusion

  • Male or female of any race or ethnicity between 18 to 49 years of age
  • Competed in a road race or triathlon in past 12 months
  • Free of chronic disease and GI conditions
  • Train at least 3 times per week, 1 hour at a time on average
  • Willing to prepare and consume provided pre-workout beverage daily
  • Maintain weight (no more/less than 5 kg change)
  • Willing to avoid consumption of high flavonoid foods/supplements, large dose vitamin and mineral supplements, and NSAIDs or other medications known to affect inflammation during study period
  • Willing to provide urine, stool, and blood samples

Exclusion

  • Age \<18 or \>50 years
  • Medical history of heart disease, hypertension, diabetes, Crohn's disease, IBS, colitis, celiac disease, inflammatory or autoimmune disease, and lactose intolerance
  • Uncontrolled hypertension: diastolic blood pressure \>95 mm Hg or systolic blood pressure \>160 mm Hg
  • For women: pregnancy, breast feeding or postpartum \<6 months
  • Food allergies or restrictions to treatment/placebo beverages
  • Chronic use of NSAIDs
  • Consumption of flavonoid supplements \<1 month prior to study start
  • Antibiotic use \<3 months prior to study start
  • Other conditions (medical, psychiatric, or behavioral) that may present a safety hazard to the participant or interfere with study participation, as determined by the principal investigators

Key Trial Info

Start Date :

September 14 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 31 2019

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT03427879

Start Date

September 14 2018

End Date

July 31 2019

Last Update

February 25 2021

Active Locations (1)

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1

Center for Human Nutrition Studies

Logan, Utah, United States, 84322