Gut Permeability, Gut InflammationPhase 1NCT03427879
Effect of Flavonoids on Gut Permeability in Cyclists
A Phase 1 study testing Low flavonoid beverage and High flavonoid beverage in people with Gut Permeability, Gut Inflammation, run by Utah State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Permeability, Gut Inflammation
- What is being tested?
- Low flavonoid beverage and High flavonoid beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2018to 31 Jul 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Human Nutrition Studies
Logan, Utah, 84322
About this study
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
- Being tested
- Low flavonoid beverage, High flavonoid beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low flavonoid beverageDrug
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 beverageDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Low flavonoid beverage | Placebo comparator | Subjects will consume 310 milliliters per day of a dairy-based, low flavonoid, sports nutrition recovery beverage 14 days. Receives: Drug: Low flavonoid beverage |
| High flavonoid beverage | Active comparator | Subjects will consume 310 milliliters per day of a dairy-based, high flavonoid, sports nutrition recovery beverage 14 days. Receives: Drug: High flavonoid beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three weeks
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.
Measured: Three weeks
Secondary outcomes (8)
Fecal calprotectin by ELISA
Secondary endpoint for intestinal inflammation. Calprotectin is measured in fecal samples by enzyme-linked immunosorbent assay.
Measured: Three weeks
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.
Measured: Three weeks
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.
Measured: Three weeks
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.
Measured: Three weeks
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.
Measured: Three weeks
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.
Measured: Three weeks
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.
Measured: One Day
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.
Measured: One Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start14 Sep 2018
- Primary completion15 May 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gut Permeability, Gut InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utah State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Ward, Utah State University
- Investigators
- Robert E Ward, PhD, Principal investigator, Nutrition, Dietetics and Food Sciences, Utah State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427879
- Sponsor's protocol ID
- 1010820
- Status last verified
- Feb 2021
- First submitted
- 30 Jan 2018
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36445874
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Flavonoids on Gut Permeability in Cyclists
- ClinicalTrials.gov ID
- NCT03427879
- Acronym / sponsor ID
- 1010820
- Conditions
- Gut Permeability, Gut Inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Utah State UniversityUniversity, hospital or other
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low flavonoid beverage | Placebo comparator | Drug: Low flavonoid beverageSubjects will consume 310 milliliters per day of a dairy-based, low flavonoid, sports nutrition recovery beverage 14 days. |
| High flavonoid beverage | Active comparator | Drug: High flavonoid beverageSubjects will consume 310 milliliters per day of a dairy-based, high flavonoid, sports nutrition recovery beverage 14 days. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low flavonoid beverageA 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. | Drug | Low flavonoid beverage |
| High flavonoid beverageA 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. | Drug | High flavonoid beverage |
Primary outcome
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.
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.
8 secondary outcomes
Fecal calprotectin by ELISA
Time frame: Three weeks
Urinary sucralose:mannitol ratio by gas chromatography
Time frame: Three weeks
Serum soluble tumor necrosis factor (TNFa) by ELISA
Time frame: Three weeks
Serum soluble interleukin-6 (IL-6) by ELISA
Time frame: Three weeks
Serum soluble interleukin-10 by ELISA
Time frame: Three weeks
Serum endotoxin by ELISA.
Time frame: Three weeks
Distance ridden in time trial
Time frame: One Day
Rating of perceived exertion by questionnaire.
Time frame: One Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Derived from this study: PubMed 36445874Kung 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.
- Individual participant dataSharing planned: Undecided
Related trials for Gut Permeability, Gut Inflammation
Recruiting
Changes in Intestinal Permeability and Systemic Inflammation Following Fast Food Overfeeding.
Obesity & Overweight
RecruitingObservational study
Microbiome in Aging of Gut and Brain
Mild Cognitive Impairment, Alzheimer Disease (AD)
Recruiting
Postprandial Effects of Fresh Mango as a Table Sugar Replacement in High-Sugar Breakfasts.
Healthy Participants
Recruiting
Tolerance to an Artisanal Bread in a Population Intolerant of the Conventional Bread and Study of Associated Markers
Intolerance to "Conventional" Bread
Recruiting
Prebiotic Effects of California Grapes on Gut Health and Cardiometabolic Health in Overweight Men and Women
Arterial Stiffness, Blood Pressure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert E Ward, PhD principal investigator
Nutrition, Dietetics and Food Sciences, Utah State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low flavonoid beverage and High flavonoid beverage in people with Gut Permeability, Gut Inflammation, run by Utah State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary lactulose:mannitol ratio by gas chromatography (time frame: Three weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03427879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.