Influence of 2-Weeks Hemp Fiber Ingestion on Gut Permeability and Metabolite Shifts After Vigorous Exercise
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Gut permeability
研究概览
简要总结
Two bioactive compounds, N-trans-caffeoyl tyramine (NCT) and N-trans-feruloyl tyramine (NFT), have been investigated for potential gut health benefits. The shells of hemp seeds are a rich source of NCT and NFT. The hypothesis for this project is that ingestion of a hemp fiber bar containing NCT and NFT will mitigate exercise-induced increases in gut permeability. This study will examine the efficacy of 2-weeks ingestion of a hemp fiber bar (high and low doses) in moderating exercise-induced gut permeability using a randomized crossover trial.
Objective #1: To conduct a randomized crossover trial using placebo-controlled, double-blind procedures with 20 cyclists who will in random order ingest a hemp fiber bar supplement (high and low doses) or placebo each day for two weeks prior to an exercise challenge (2.25 hours of intensive cycling).
Objective #2: To determine if hemp fiber bar supplementation attenuates exercise-induced gut permeability using several outcome measures including plasma lactulose to 13C mannitol (L:M) ratio and plasma intestinal fatty acid binding protein (I-FABP) as markers of gastrointestinal permeability and mucosal damage, respectively. Shifts in thousands of metabolites will be measured via untargeted metabolomics to provide additional gut permeability biomarkers and help reveal underlying mechanisms.
详细描述
This study will employ a randomized crossover design. Study participants will be block randomized to three trials (high and low dose hemp fibers bars or placebo) using double-blinded, placebo-controlled procedures. The supplement bars will be coded by the sponsor, with the double-blind code held until after all study samples have been analyzed. Subjects will come to the lab for orientation/baseline testing, pre-and post-supplementation blood sample collections (2 weeks supplementation with high and low dose hemp fiber bar supplements or placebo), and three 2.25 h cycling sessions (thus 9 total lab visits).
A. Orientation (Visit #1). Subjects will report to the lab in an overnight fasted state. Subjects will voluntarily sign IRB-approved consent forms and complete questionnaires (delayed onset of muscle soreness or DOMS, Profile of Mood States or POMS). Demographic, health, and training histories will be acquired with questionnaires. A blood sample will be collected. Subjects will ingest a standardized sugar solution containing lactulose 5 g, 13C mannitol 100 mg, mannitol 1.9 g, and rhamnose 1 g in a total of 450 ml water (SS, calculated osmolality 69 mosmol/kg). An increase in the post-exercise lactulose/13C mannitol ratio (L/M) will be used as an indicator of increased gut permeability. All urine excreted from 0-5 h post SS ingestion will be collected in a urine collection container. Subjects will be urged to drink water after the first hour of the test to ensure adequate urine output. The Boost beverage will be consumed at 7 kcal/kg 1.5 h post SS ingestion (to simulate what occurs post-exercise). The urine collection container will be placed in the refrigerator until they are returned to the lab the next day. The total urine volume will be measured with four 50 ml aliquots frozen in a minus 80°C freezer until analysis.
B. Baseline Testing/Pre-Supplementation (Visit #2). Subject will return urine collection container to the HPL the day after Visit #1. Body composition will be measured with the seca BIA and Bod Pod body composition analyzer (Life Measurement, Concord, CA). Study participants will be tested for maximal aerobic capacity (VO2max) during a graded, cycling test with continuous metabolic monitoring with the Cosmed CPET metabolic device (Cosmed, Rome, Italy). A 2-week supply of high dose or low dose hemp fiber bars or placebo bars will be given to the participants. Subjects will consume 2 bars per day, one with the first meal in the morning and the second bar with the last meal of the day.
C. 2.25 h Cycling Session (Lab Visit #3): During the 3-day period prior to the 2.25-h cycling session, subjects will taper exercise training and ingest a moderate-carbohydrate diet using a food list restricting high fat foods, visible fats, and caffeine. Subjects will record all food and beverage intake in a 3-day food record with macro- and micro-nutrient intake calculated using the ESHA Food Processor nutrient analysis software program. Study participants will report to the Human Performance Lab in an overnight fasted state and provide a blood sample, ingest the supplement (1 hemp fiber bar or placebo bar), and then cycle 2.25 h at high intensity (70% VO2max) while ingesting water alone (3 ml/kg every 15 minutes). Immediately following the cycling bout, subjects will ingest the SS. Blood samples will be collected at 0 h, 1.5 h, and 3.0 h post-exercise. All urine excreted from 0-5 h after SS ingestion will be collected in a urine collection container.
Testing protocol during the lab sessions with the 2.25-h cycling session:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Investigators and study participants will be blind to treatment allocation, with the hemp fiber-based supplement bars and placebo supplement bar of the same texture, taste, and look.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female cyclists, ages 18-65 years, and capable of cycling 2.25 h in the laboratory at 60% watts maximum (close to long-distance race pace).
- •Non-smoker, and generally healthy and without gastrointestinal diseases (irritable bowel syndrome, chronic nausea, vomiting, and diarrhea, Crohn's disease, Celiac disease, diverticulosis) or chronic diseases including cardiovascular disease (e.g., heart disease, stroke), cancer, type 1 and 2 diabetes, rheumatoid arthritis. Categorized as "low risk" using the American College of Sports Medicine screening questionnaire.
- •Agree to train normally, maintain weight, and avoid the regular use of large-dose vitamin and mineral supplements, herbs, and medications that influence inflammation (especially non-steroidal antiinflammatory drugs or NSAIDs) for the duration of the 10-week study and at least a 2-week period prior to the study.
- •Agree to taper your exercise routine prior to each of the 3 lab cycling sessions (as if preparing for a race event).
- •Agree to restrict (i.e., avoid high amounts of) black pepper, red pepper, garlic, curry, and other strong spices during the 3-day period prior to each lab visit.
排除标准
- •Inability to comply with study requirements.
- •Females trying to become pregnant, or currently pregnant or breastfeeding.
- •Nonpregnant adults who weigh less than 110 pounds.
- •Any other concurrent condition which, in the opinion of the principal investigator (PI), would preclude participation in this study or interfere with compliance.
- •Current diagnosis of gastrointestinal disease, cardiovascular disease, diabetes, or cancer (except for non-melanoma skin cancer).
- •Sensitivity to hemp fiber.
- •History of intolerance to cow's milk and lactose.
- •History of adverse symptoms to low amounts of lactulose, mannitol, and rhamnose sugars (low calorie and poorly absorbed sugars).
结局指标
主要结局
Gut permeability
时间窗: Change from pre-supplementation levels to 5 hours post-exercise
Urine concentrations of post-exercise lactulose/13C mannitol ratio (L/M)
次要结局
- Changes in plasma hemp fiber-related metabolites including acetic acid, propionic acid, and butyric acid from targeted metabolomics using LC-MS/MS analysis (relative intensities)(Change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise)