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临床试验/NCT05907135
NCT05907135已完成不适用

Influence of 2-Weeks Beet Pre-Workout Supplement Ingestion on Inflammation Resolution and Metabolic Recovery After Vigorous Exercise

Appalachian State University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Plasma lipid mediators

研究概览

简要总结

This study will determine if ingesting a beet-based supplement with nitrates for 2 weeks moderates exercise-induced inflammation.

详细描述

RESEARCH DESIGN: Subjects will come to the lab for orientation/baseline testing, pre-and post-supplementation blood sample collections (2 weeks supplementation with POSSIBLE Beet Pre-Workout supplement (Standard Process, Kannapolis, NC) or placebo), two 2.25 h cycling sessions, and additional lab visits to provide 1-day 7:00 am recovery blood samples) (thus 7 total lab visits). The total amount of time subjects will be asked to volunteer for this study is about 20 hours at the Human Performance Laboratory (over a 6-week period).

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.

B. Pre-Supplementation Lab Visit #2 and 2-Week Supplementation Protocol: Two weeks prior to the first cycling session, subjects will report to the Human Performance Laboratory at approximately 7:00-8:00 am. A blood sample will be collected in an overnight fasted state to coincide with the same time of the day for the post-supplementation blood draw. A 2-week supply of POSSIBLE Beet Pre-Workout supplement or placebo supplement will be given to the participants. Subjects will mix the supplement powder in one cup of cold water and consume one dose in the early morning and a second dose mid-day.

POSSIBLE Beet Pre-Workout supplement (subjects will consume 2 scoops per day, 28 grams total, with one dose in the early morning, and the second dose mid-day). Note: the placebo will include excipients only, with none of the ingredients listed below.

Ingredients (per 14 g scoop dose) Beets: Beets in combination with fermented beets to provide nitrates (106 mg of nitrates per serving).

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 beet-based supplement and placebo supplement of the same color and taste.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female cyclists, ages 18-60 years, and capable of cycling 2.25 h in the laboratory at 70% VO2max (close to race pace).
  • Non-smoker, and 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 6-week study and at least a 2-week period prior to the study.
  • Agree to limit intake of nitrate-rich vegetables during the study to less than 1 cup per day. These include spinach, lettuce, beets, beetroot juice, celery, and cabbage.
  • Agree to taper their exercise routine prior to each of the two lab cycling sessions.
  • Agree to avoid the use of mouthwashes, antacids, and chewing gum during the entire 6-week study and the 2-week period prior to the study.

排除标准

  • Inability to comply with study requirements.
  • Females: body weight below 110 pounds; trying to become pregnant, pregnant or breastfeeding.
  • 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 cardiovascular disease, diabetes, or cancer (except for non-melanoma skin cancer).
  • An unwillingness to avoid mouthwashes, antacids, and chewing gum 2 weeks before and during the 6-week study.
  • An unwillingness to limit intake of nitrate-rich vegetables 2 weeks before and during the 6-week study.
  • Current history of uncontrolled hypertension and/or the use of vasodilatory medications.
  • Sensitivity to caffeine intake from green tea extract (200 mg per day).
  • History of allergic reactions to any of the ingredients in the study supplement: beet powder, camu camu, green tea extract, mushroom blend (caterpillar fungus, lion's mane, chaga), quinoa sprouts, monk fruit, pineapple, cranberry seed powder, strawberry fruit powder).

结局指标

主要结局

Plasma lipid mediators

时间窗: Change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise

Plasma concentrations of arachidonic acid oxidized derivatives from LC-MS/MS analysis

次要结局

  • Plasma proteins(Change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise)
  • Plasma nitrate and nitrite concentrations(Change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, and 24 hours-post-exercise)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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