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Effect of Flavonoids on Gut Permeability in Cyclists

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ClinicalTrials.gov Identifier: NCT03427879
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Robert Ward, Utah State University

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.

Condition or disease Intervention/treatment Phase
Gut Permeability, Gut Inflammation Drug: Low flavonoid beverage Drug: High flavonoid beverage Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Flavonoids on Gut Permeability in Cyclists
Actual Study Start Date : September 14, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : July 31, 2019

Arm Intervention/treatment
Placebo Comparator: Low flavonoid beverage
Subjects will consume 310 milliliters per day of a dairy-based, low flavonoid, sports nutrition recovery beverage 14 days.
Drug: 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.

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




Primary Outcome Measures :
  1. Urinary lactulose:mannitol ratio by gas chromatography [ Time Frame: Three weeks ]
    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.

  2. Plasma intestinal fatty acid binding protein (i-FABP) by ELISA [ Time Frame: Three weeks ]
    Marker of gut wall integrity. i-FABP is measure by enzyme-linked immunosorbent assay in plasma of subjects after the time trial.


Secondary Outcome Measures :
  1. Fecal calprotectin by ELISA [ Time Frame: Three weeks ]
    Secondary endpoint for intestinal inflammation. Calprotectin is measured in fecal samples by enzyme-linked immunosorbent assay.

  2. Urinary sucralose:mannitol ratio by gas chromatography [ Time Frame: Three weeks ]
    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.

  3. Serum soluble tumor necrosis factor (TNFa) by ELISA [ Time Frame: Three weeks ]
    One of four secondary endpoints for systemic inflammation. The cytokine, TNFa, is measured in plasma by enzyme-linked immunosorbent assay.

  4. Serum soluble interleukin-6 (IL-6) by ELISA [ Time Frame: Three weeks ]
    One of four secondary endpoints for systemic inflammation. The cytokine, IL-6, is measured in plasma by enzyme-linked immunosorbent assay.

  5. Serum soluble interleukin-10 by ELISA [ Time Frame: Three weeks ]
    One of four secondary endpoints for systemic inflammation. The cytokine, IL-10, is measured in plasma by enzyme-linked immunosorbent assay.

  6. Serum endotoxin by ELISA. [ Time Frame: Three weeks ]
    One of four secondary endpoint for systemic inflammation. The bacterial cell wall product is measured in plasma by enzyme-linked immunosorbent assay.

  7. Distance ridden in time trial [ Time Frame: One Day ]
    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.

  8. Rating of perceived exertion by questionnaire. [ Time Frame: One Day ]
    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.



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427879


Contacts
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Contact: Robert E Ward, PhD 435-797-2153 robert.ward@usu.edu
Contact: Michael Lefevre, PhD 435-797-3821 michael.lefevre@usu.edu

Locations
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United States, Utah
Center for Human Nutrition Studies Recruiting
Logan, Utah, United States, 84322
Contact: Janet Bergerson, RN, MS    435-797-8262    janet.bergeson@usu.edu   
Contact: Michael Lefevre, PhD    435-797-3821    michael.lefevre@usu.edu   
Sponsors and Collaborators
Utah State University
Investigators
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Principal Investigator: Robert E Ward, PhD Nutrition, Dietetics and Food Sciences, Utah State University

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Responsible Party: Robert Ward, Associate Professor, Utah State University
ClinicalTrials.gov Identifier: NCT03427879     History of Changes
Other Study ID Numbers: 1010820
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes