Effect of Flavonoids on Gut Permeability in Cyclists
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Urinary lactulose:mannitol ratio by gas chromatography
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Low flavonoid beverage
Subjects will consume 310 milliliters per day of a dairy-based, low flavonoid, sports nutrition recovery beverage 14 days.
干预措施: Low flavonoid beverage (Drug)
High flavonoid beverage
Subjects will consume 310 milliliters per day of a dairy-based, high flavonoid, sports nutrition recovery beverage 14 days.
干预措施: High flavonoid beverage (Drug)
结局指标
主要结局
Urinary lactulose:mannitol ratio by gas chromatography
时间窗: 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
时间窗: Three weeks
Marker of gut wall integrity. i-FABP is measure by enzyme-linked immunosorbent assay in plasma of subjects after the time trial.
次要结局
- Serum soluble interleukin-10 by ELISA(Three weeks)
- Rating of perceived exertion by questionnaire.(One Day)
- Fecal calprotectin by ELISA(Three weeks)
- Urinary sucralose:mannitol ratio by gas chromatography(Three weeks)
- Serum soluble tumor necrosis factor (TNFa) by ELISA(Three weeks)
- Serum soluble interleukin-6 (IL-6) by ELISA(Three weeks)
- Distance ridden in time trial(One Day)
- Serum endotoxin by ELISA.(Three weeks)
研究者
Robert Ward
Associate Professor
Utah State University