Effect of Flavonoids on Gut Permeability in Cyclists

NCT ID: NCT03427879

Last Updated: 2021-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-14
• Study Completion Date: 2019-07-31

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.

Conditions

Gut Permeability, Gut Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Low flavonoid beverage

Subjects will consume 310 milliliters per day of a dairy-based, low flavonoid, sports nutrition recovery beverage 14 days.

Group Type: PLACEBO_COMPARATOR

Low flavonoid beverage

Intervention Type: DRUG

A low flavonoid, sports nutrition recovery beverage will be prepared from milk (78%), sugar (8.6%), maltodextrin (8.6%), placebo blueberry powder (2.4%), alkalized cocoa powder (1.6%), and whey protein isolate (0.6%). The beverage will contain approximately 5mg flavonoids per serving.

High flavonoid beverage

Subjects will consume 310 milliliters per day of a dairy-based, high flavonoid, sports nutrition recovery beverage 14 days.

Group Type: ACTIVE_COMPARATOR

High flavonoid beverage

Intervention Type: DRUG

A high flavonoid, sports nutrition recovery beverage will be prepared from milk (78%), sugar (8.6%), maltodextrin (8.6%), blueberry powder (2.4%), cocoa powder (1.6%), green tea extract (0.1%) and whey protein isolate (0.6%). The beverage will contain approximately 620 mg flavonoids per serving.

Interventions

Low flavonoid beverage

A low flavonoid, sports nutrition recovery beverage will be prepared from milk (78%), sugar (8.6%), maltodextrin (8.6%), placebo blueberry powder (2.4%), alkalized cocoa powder (1.6%), and whey protein isolate (0.6%). The beverage will contain approximately 5mg flavonoids per serving.

Intervention Type: DRUG

High flavonoid beverage

A high flavonoid, sports nutrition recovery beverage will be prepared from milk (78%), sugar (8.6%), maltodextrin (8.6%), blueberry powder (2.4%), cocoa powder (1.6%), green tea extract (0.1%) and whey protein isolate (0.6%). The beverage will contain approximately 620 mg flavonoids per serving.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Utah State University

OTHER

Sponsor Role: lead

Responsible Party

Robert Ward

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert E Ward, PhD

Role: PRINCIPAL_INVESTIGATOR

Nutrition, Dietetics and Food Sciences, Utah State University

Locations

Center for Human Nutrition Studies

Logan, Utah, United States

Countries

United States

References

Kung S, Vakula MN, Kim Y, England DL, Bergeson J, Bressel E, Lefevre M, Ward R. No effect of a dairy-based, high flavonoid pre-workout beverage on exercise-induced intestinal injury, permeability, and inflammation in recreational cyclists: A randomized controlled crossover trial. PLoS One. 2022 Nov 29;17(11):e0277453. doi: 10.1371/journal.pone.0277453. eCollection 2022.

Reference Type: DERIVED

PMID: 36445874 (View on PubMed)

Other Identifiers

1010820

Identifier Type: -

Identifier Source: org_study_id