Clinical trial NCT03427879: Effect of Flavonoids on Gut Permeability in Cyclists
Official title: Effect of Flavonoids on Gut Permeability in Cyclists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gut Permeability, Gut Inflammation
Lead sponsor: Utah State University
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Urinary lactulose:mannitol ratio by gas chromatography
timeFrame: Three weeks
measure: Plasma intestinal fatty acid binding protein (i-FABP) by ELISA
timeFrame: Three weeks
Secondary outcomes:
measure: Fecal calprotectin by ELISA
timeFrame: Three weeks
measure: Urinary sucralose:mannitol ratio by gas chromatography
timeFrame: Three weeks
measure: Serum soluble tumor necrosis factor (TNFa) by ELISA
timeFrame: Three weeks
measure: Serum soluble interleukin-6 (IL-6) by ELISA
timeFrame: Three weeks
measure: Serum soluble interleukin-10 by ELISA
timeFrame: Three weeks
measure: Serum endotoxin by ELISA.
timeFrame: Three weeks
measure: Distance ridden in time trial
timeFrame: One Day
measure: Rating of perceived exertion by questionnaire.
timeFrame: One Day
Other outcomes:
Locations:
city: Logan
country: United States
facility: Center for Human Nutrition Studies
state: Utah
Study officials:
affiliation: Nutrition, Dietetics and Food Sciences, Utah State University
name: Robert E Ward, PhD
role: PRINCIPAL_INVESTIGATOR
References: