Effect of Flavonoids on Gut Permeability in Cyclists

Utah State University

Status and phase

Completed

Phase 1

Conditions

Gut Permeability, Gut Inflammation

Treatments

Drug: Low flavonoid beverage

Drug: High flavonoid beverage

Study type

Interventional

Funder types

Other

Identifiers

NCT03427879

1010820

Details and patient eligibility

About

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 natural plant compounds) will ameliorate exercise-related changes in gut permeability and inflammation. In a previous feeding study in humans, (NCT02728570) a high flavonoid diet (flavonoids at 340 mg/1000kcal) was effective in mitigating gut permeability and inflammation in overweight and obese adults compared to a low flavonoid diet (10mg/1000 kcal). To test this hypothesis, 20 trained cyclists will complete a randomized crossover study with supplementation for 2 weeks with a dairy-based sports beverage containing either a high flavonoid (approximately 620 mg) or low flavonoid (approximately 5mg) beverage. After the two week intervention, cyclists will complete a 1 hour cycling trial (45 min at 65% VO2 max then 15 minute time trial). The primary endpoints will be gut permeability as measured by plasma intestinal fatty acid binding protein (I-FABP) and the differential sugar test. Secondary endpoints will include gut inflammation (measured via fecal calprotectin), plasma cytokines (IL-6, IL-10 and TNFα) and plasma LPS. In addition, the distance completed in the time trial is a secondary endpoint.

Enrollment

12 patients

Sex

All

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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