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临床试验/NCT05407701
NCT05407701已完成不适用

Countermeasure Influence of 4-Weeks Cranberry Ingestion on Immune Dysfunction, Inflammation, and Muscle Damage Induced by Intensive Cycling

Appalachian State University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2022年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
Blood lymphocyte proliferation

研究概览

简要总结

This is a randomized, crossover clinical trial with 25 male and female cyclists. Study participants will ingest polyphenol-rich cranberry juice or placebo juice for 4 weeks under double-blinded procedures, and then crossover to the opposite supplement. The primary objective of this study is to examine the efficacy of 4-weeks ingestion of cranberry juice in moderating exercise-induced inflammation, immune dysfunction, and muscle damage. Outcome measures will include global proteiomics, oxylipins, and cytokines.

详细描述

RESEARCH DESIGN: Subjects will come to the lab for orientation/baseline testing, pre-and post-supplementation (4 weeks cranberry ingestion compared to water alone) blood, stool, and urine sample collections with 3-d food records, two 2.25 h cycling sessions, and additional lab visits to provide 1-day 7:00 am recovery blood and saliva samples) (thus 7 total lab visits). The total amount of time subjects will be asked to volunteer for this study is about 16 hours at the Human Performance Laboratory (over a 10-week period).

1.A. Orientation/Baseline Testing (Visit #1) After voluntarily signed IRB-approved consent forms, 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). Body composition will be measured with the seca BIA and Bod Pod body composition analyzer (Life Measurement, Concord, CA). Demographic and training histories will be acquired with questionnaires. 3-day food records, 24-h urine collection kits, and stool collection kits will be supplied with thorough instructions.

B. Pre-Supplementation Lab Visit #2 and 4-Week Cranberry Supplementation Protocol: Four weeks prior to the first cycling session, subjects will report to the Human Performance Laboratory at approximately 7:00-8:00 am. DOMS and POMS questionnaires will be administered. To assess potential adverse effects, a symptom inventory will be conducted using a 4-week retrospective questionnaire (before and after the 4-week supplementation period). Blood and saliva samples will be collected in an overnight fasted state to coincide with the same time of the day for the post-supplementation blood draw. Urine samples, stool samples, and 3-d food records will be turned in. A 4-week supply of cranberry juice or placebo will be given to the participants, with instructions to consume 4 fl. Oz. each with the first and last meals of the day (8 fl. Oz. per day for 4 weeks). Subjects will be instructed to store and then bring the cranberry and placebo beverage containers to their next lab visit (to verify compliance). Subjects will be given a 10-week log book to record daily whether or not they are sick and the severity of their symptoms.

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 polyphenols. Subjects will record all food and beverage intake during the 3-day period, with macro- and micro-nutrient intake assessed using the Food Processor dietary analysis software system (ESHA Research, Salem, OR). We will also measure total flavonoid intake (and 6 flavonoid subgroups) using the USDA flavonoid database that we have incorporated into the Food Processor database (9). Study participants will report to the Human Performance Lab in an overnight fasted state, turn in urine and stool samples, provide blood and saliva samples, ingest 1 cup cranberry with 1 cup of water, or 1 cup of water alone, and then cycle 2.25 h at high intensity (70% VO2max) while ingesting water alone (3 ml/kg every 15 minutes). A sweat patch will be applied to the lower back before exercise begins and then taken off immediately after the exercise bout is complete (https://www.epicorebiosystems.com/gx-sweat-patch/). Blood and saliva samples will be collected at 0 h, 1.5 h, 3.0 h, and 24 h post-exercise.

Testing protocol during the lab sessions with the 2.25-h run 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 cranberry and placebo beverages of the same taste and color, and contained in identical looking bottles.

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Male or female cyclist, ages 18-55 years, and capable of cycling 2.25 h in the lab on trainers at 70% VO2max (close to race pace).
  • •Non-smoker
  • •Generally healthy and without chronic disease 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 NSAIDs) for the duration of the 10-week study.
  • •Agree to taper their exercise routine prior to each of the two lab cycling sessions.
  • •Agree to avoid ingestion of cranberry products during the study (other than provided).

排除标准

  • •Inability to comply with study requirements.
  • •History of allergic reactions to cranberry ingestion.
  • •Females: body weight below 110 pounds; pregnant or breastfeeding.
  • •Any other concurrent condition which, in the opinion of the principle investigator (PI), would preclude participation in this study or interfere with compliance.
  • •Current diagnosis of cardiovascular disease, diabetes, or cancer (except for non-melanoma skin cancer).

研究组 & 干预措施

Placebo

Placebo Comparator

100% juice placebo: water, fructose, dextrose, citric acid, malic acid, natural flavors, pectin, cherry colorant, sucralose.

干预措施: Placebo (Dietary Supplement)

Cranberry

Experimental

100% juice active: water, cranberry juice concentrate.

干预措施: Cranberry Juice (Dietary Supplement)

结局指标

主要结局

Blood lymphocyte proliferation

时间窗: Change from pre-study to post-4 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise

The mitogenic response of lymphocytes will be determined in whole blood culture using suboptimal mitogen (Concanavalin A) doses

次要结局

  • Plasma proteins(Change from pre-study to post-4 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise)
  • Plasma lipid mediators(Change from pre-study to post-4 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise)
  • Plasma cytokine panel(Change from pre-study to post-4 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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