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临床试验/NCT04007731
NCT04007731已完成不适用

Effects of New Protein Bar on Biochemical and Physiological Parameters in Physically Active People

Zala Jenko Praznikar2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
2
主要终点
Fat mass

研究概览

简要总结

Post-exercise nutrition is an important factor in a nutrition plan for physically active subjects. Focusing on that, the Serbian group is developing protein bars enriched with sports supplements. Slovenian partner group will investigate the effect of new protein bar consumption on body composition, biochemical parameters, and muscle regeneration after training. The new bar will be compared with a commercially available bar.

详细描述

The clinical study will be performed on 10 elite handball players from Slovenia handball club. It will be designed as a crossover study. Half of the participants will consume the new bar for five days and the other half will consume the control bar. After the five-day washout period, the groups will consume the bar which was not consumed in the first period.

At baseline, at the end of every intervention and washout period, the blood samples will be withdrawn, and the body composition will be analyzed.

The analyzed biochemical parameters will be basic serum parameters, such as fasting glucose, total cholesterol, LDL, HDL, triglycerides, aspartate aminotransferase (AST), alanine aminotransferase (ALT), C-reactive protein (CRP), and parameters related to the muscle regeneration and inflammation, such as creatine kinase, lactate dehydrogenase, insulin-like growth factor (IGF), tumor necrosis factor alpha (TNF-alpha), interleukin 6 (IL-6), monocyte chemoattractant protein 1 (MCP-1).

In the second part of the study, the acute effect of consuming each bar after training will be tested. Each participant will consume both bars on separate days. The mentioned parameters will be assessed after training and immediately and 3h after bar consumption.

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
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • daily high-intensity physical activity

排除标准

  • smoking, cardiovascular, neurological, skeletal muscle disease, allergies

结局指标

主要结局

Fat mass

时间窗: 15 days

Fat mass in kilograms will be determined using bioelectrical impedance analysis (BIA).

Muscle mass

时间窗: 15 days

Muscle mass in kilograms will be determined using bioelectrical impedance analysis (BIA).

次要结局

  • C-reactive protein(15 days)
  • Lactate dehydrogenase(15 days)
  • Tumor necrosis factor alpha(15 days)
  • Creatine kinase(15 days)

研究者

发起方
Zala Jenko Praznikar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zala Jenko Praznikar

assistant professor

University of Primorska

研究点 (2)

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