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Effect of Flavonoids on Gut Permeability in Cyclists

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EstadoReclutamiento
Patrocinadores
Utah State University

Palabras clave

Abstracto

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.

fechas

Verificado por última vez: 09/30/2018
Primero enviado: 01/29/2018
Inscripción estimada enviada: 02/01/2018
Publicado por primera vez: 02/08/2018
Última actualización enviada: 10/09/2018
Última actualización publicada: 10/14/2018
Fecha de inicio real del estudio: 09/13/2018
Fecha estimada de finalización primaria: 02/27/2019
Fecha estimada de finalización del estudio: 07/30/2019

Condición o enfermedad

Gut Permeability, Gut Inflammation

Intervención / tratamiento

Drug: Low flavonoid beverage

Drug: High flavonoid beverage

Fase

Fase 1

Grupos de brazos

BrazoIntervención / tratamiento
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.

Criterio de elegibilidad

Edades elegibles para estudiar 18 Years A 18 Years
Sexos elegibles para estudiarAll
Acepta voluntarios saludablessi
Criterios

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

Salir

Medidas de resultado primarias

1. Urinary lactulose:mannitol ratio by gas chromatography [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 [Three weeks]

Marker of gut wall integrity. i-FABP is measure by enzyme-linked immunosorbent assay in plasma of subjects after the time trial.

Medidas de resultado secundarias

1. Fecal calprotectin by ELISA [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 [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 [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 [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 [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. [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 [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. [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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