A Randomized, Crossover Pilot to Examine the Acute Impact of Veillonella Supplementation on Exercise and Lactate Responses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Blood lactate response to intense exercise
研究概览
简要总结
The purpose of this study is to assess the health and performance outcomes associated with supplementation of Veillonella atypica.
详细描述
This pilot study will be conducted using a randomized, double-blind, crossover study design. Healthy men and women (n=7) between the ages of 18 - 50 years of age will be recruited for this study. After signing an IRB-approved consent form, participants will have their peak VO2 determined to finalize eligibility. Eligible participants will then practice their first time to exhaustion trial at 100% VO2Peak. Prior to each subsequent study visit, participants will be scheduled at a similar time between the hours of 0600 and 1000 hours and will be asked to observe an overnight fast (food, caffeine, and nicotine) while refraining from any vigorous exercise for at least 24 hours prior to their visit. During visit 2, participants will have their body composition assessed and complete another time to exhaustion familiarization at 100% VO2Peak. Leading up to and during each subsequent study visit (identical to visit 3), participants will collect a stool sample and upon arrival at the laboratory have their body mass measured before having a venous blood sample collected for assessment of complete blood count and comprehensive metabolic panel. After blood collection, participants will complete the standardized warm-up before completing a treadmill time to exhaustion test at 100% VO2Peak. Capillary lactate levels will be assessed before, immediately after, and 5 minutes after completion of the exhaustion trial using a handheld lactate analyzer. From there and in a randomized, double-blind, placebo-controlled, crossover fashion, participants will be assigned for the next 14 days to ingest either a placebo (maltodextrin) or a 1 x 109CFU dose of Veillonella atypica FB004 (VA) (Fitbiomics, Inc. New York). After supplementing for 14 days, participants will complete an identical battery of tests. Participants will then follow a wash-out period for 21 days before returning to the laboratory to complete study visit 5, the pre-supplementation visit to their supplementation period. After completing study visit 5, participants will be instructed to supplement with the alternative supplement for 14 days before returning for a 6th and final study visit. Participants will complete a two-day food and fluid record prior to visit 3, receivea copy of it from study investigators, and be instructed to replicate it prior to each subsequent study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The same number of capsules will be provided to each participant. Each capsule will be identical in color, shape, smell, and transparency. Participants will be instructed to consume their assigned dose with 8 - 12 fluid ounces of cool water.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide voluntary signed and dated informed consent.
- •Be in good health as determined by medical history and routine blood chemistries.
- •Age between 18 and 50
- •Exercises > 150 mins/week
- •Body Mass Index of 18.5-29.9 and Body Fat of 30%
- •Normotensive (seated, resting systolic blood pressure < 140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
- •Normal seated, resting heart rate (< 90 beats per minute). Willing to follow all study protocols.
排除标准
- •Individuals currently diagnosed or being treated for any cardiac, respiratory, endocrine, psychiatric, musculoskeletal, renal, hepatic, neuromuscular or metabolic disease or disorder that in the judgement of the study participant's personal physician or research nurse that will preclude their safe participation or will contraindicate quality control over the collected data
- •Individuals currently diagnosed with or are being treated for celiac disease, lactose intolerance, digestive insufficiencies or other gastrointestinal complications such as irritable bowel syndrome, ulcerative colitis, etc.
- •Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence.
- •Smokers or individuals who have quit smoking within the last 6 months
- •Known sensitivity to any ingredient in the test formulations as listed in the Nutrition Facts label.
- •Individuals who are determined to be on a ketogenic diet.
- •Individuals who are cognitively impaired and/or who are unable to give informed consent.
- •Individuals taking a medication known to impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients
- •Individuals currently taking a probiotic or a dietary supplement that may impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients
- •Pregnant women, women trying to become pregnant, or nursing women.
- •Participants who indicate they are actively restricting calories or attempting to lose weight.
- •Individuals who do not participate in aerobic exercise > 2 days/week
- •Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose a significant risk to the subject.
结局指标
主要结局
Blood lactate response to intense exercise
时间窗: 2 weeks
Blood lactate response to treadmill running at 100% VO2peak protocol til exhaustion
Aerobic Exercise Performance
时间窗: 2 weeks
Time to Exhaustion treadmill running at 100% VO2peak
次要结局
- Changes in red blood cell count(2 weeks)
- Alpha and beta diversity of veillonella atypica (fecal samples)(2 weeks)
- Changes in blood Calcium Concentration(2 weeks)
- Changes in blood creatinine Concentration(2 weeks)
- Changes in blood total protein Concentration(2 weeks)
- Changes in blood Aspartate aminotransferase (AST) Concentration(2 weeks)
- Changes in blood Alanine Aminotransferase (ALT) Concentration(2 weeks)
- Changes in blood Hemoglobin concentration(2 weeks)
- Changes in blood hematocrit(2 weeks)
- Changes in red blood cell distribution width(2 weeks)
- Changes in mean corpuscular hemoglobin concentration (MCHC)(2 weeks)
- Changes in white blood cell count(2 weeks)
- Changes in basophils(2 weeks)
- Changes in blood Bilirubin Concentration(2 weeks)
- Changes in blood Chloride Concentration(2 weeks)
- Changes in blood Carbon Dioxide Concentration(2 weeks)
- Changes in mean corpuscular hemoglobin (MCH)(2 weeks)
- Changes in platelet count(2 weeks)
- Changes in eosinophils(2 weeks)
- Changes in blood Sodium Concentration(2 weeks)
- Changes in blood Potassium Concentration(2 weeks)
- Changes in blood Blood Urea Nitrogen (BUN) Concentration(2 weeks)
- Changes in blood Albumin Concentration(2 weeks)
- Changes in mean corpuscular volume (MCV)(2 weeks)
- Changes in neutrophils(2 weeks)
- Changes in blood Glucose Concentration(2 weeks)
- Changes in blood alkaline phosphate Concentration(2 weeks)
- Changes in blood Globulin Concentration(2 weeks)