Gut Permeability, Gut Inflammation Clinical Trial
Official title:
Effect of Flavonoids on Gut Permeability in Cyclists
| Verified date | February 2021 |
| Source | Utah State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | July 31, 2019 |
| Est. primary completion date | May 15, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 49 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Center for Human Nutrition Studies | Logan | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Utah State University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Urinary lactulose:mannitol ratio by gas chromatography | Measure of gut permeability from mouth to end of small intestine. Ratio of urinary lactulose to mannitol after subject consumes a beverage containing these sugars. Sugars in urine are measured by gas chromatography with flame ionization detection. | Three weeks | |
| Primary | Plasma intestinal fatty acid binding protein (i-FABP) by ELISA | Marker of gut wall integrity. i-FABP is measure by enzyme-linked immunosorbent assay in plasma of subjects after the time trial. | Three weeks | |
| Secondary | Fecal calprotectin by ELISA | Secondary endpoint for intestinal inflammation. Calprotectin is measured in fecal samples by enzyme-linked immunosorbent assay. | Three weeks | |
| Secondary | Urinary sucralose:mannitol ratio by gas chromatography | Secondary measure of gut permeability from mouth to end of colon. Ratio of urinary lactulose to mannitol after subject consumes a beverage containing these sugars. Sugars in urine are measured by gas chromatography with flame ionization detection. | Three weeks | |
| Secondary | Serum soluble tumor necrosis factor (TNFa) by ELISA | One of four secondary endpoints for systemic inflammation. The cytokine, TNFa, is measured in plasma by enzyme-linked immunosorbent assay. | Three weeks | |
| Secondary | Serum soluble interleukin-6 (IL-6) by ELISA | One of four secondary endpoints for systemic inflammation. The cytokine, IL-6, is measured in plasma by enzyme-linked immunosorbent assay. | Three weeks | |
| Secondary | Serum soluble interleukin-10 by ELISA | One of four secondary endpoints for systemic inflammation. The cytokine, IL-10, is measured in plasma by enzyme-linked immunosorbent assay. | Three weeks | |
| Secondary | Serum endotoxin by ELISA. | One of four secondary endpoint for systemic inflammation. The bacterial cell wall product is measured in plasma by enzyme-linked immunosorbent assay. | Three weeks | |
| Secondary | Distance ridden in time trial | Subjects will complete a 15m time trial on a bike after each dietary intervention. The distance covered in each time trial will be measured by the computer on the exercise bike. | One Day | |
| Secondary | Rating of perceived exertion by questionnaire. | Subjects will complete a 15m time trial on a bike after each dietary intervention. This measure is a subjective measure of the difficulty of the work. Subjects will provide the ratings orally during the time trial. | One Day |