The Effect of Protein Hydrolysate Supplementation to Influence the Expression of Strength Recovery and Systemic Muscle Function Markers Following Resistance Type Exercise in Male Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in strength recovery
研究概览
简要总结
A randomised placebo controlled, double-blind, 30 Volunteer trial of Elio™ administered 2.4 grams per day in assessing its effects on post-exercise strength recovery and increases in markers associated with muscle injury and exertion.
详细描述
Periods of intense physical activity and exertion can lead to disruption of normal muscle homeostasis and the resultant muscle injury and recovery can impact upon quality of life especially in adult populations. Recovery post-exercise is therefore important to all active people.
There is a link between high-intensity exercise and reduced power and performance in the following exercise sessions. The effect on performance is measures as a reduced muscle force production or loss in strength and can correlate with delayed onset muscle soreness (DOMS). The reduced power/performance seen 24 hours - 7days post-exercise is affected by recovery methods applied, individual fitness levels and intensity of exercise injury.
Several theories have been proposed to explain the mechanisms underlying DOMS. These include inflammation and muscle damage.
Exercise-induced muscle damage is a transient phenomenon caused by unfamiliar, damaging exercise and is characterized by structural damage to myofibers and secondary inflammation. Signs and symptoms often persist for several days after exercise and typically include muscle soreness, elevated blood levels of intramuscular enzymes such as creatine kinase (CK), lactate dehydrogenase (LDH) and myoglobin (MB) that often result in elevations in circulating markers of inflammation such as C-reactive protein (CRP) and various interleukins. To date, extensive research has been published that explore the many recovery strategies purported to minimize indirect markers of muscle damage.
However, from a nutritional standpoint the results are weak. It is therefore important to develop nutritional products that can lessen the impact of these injuries' individuals succumb to or expedite their recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males between 30 and 45 years of age
- •Participants agree to comply with study procedures. Participants agree to comply with study procedures.
- •Participants agree to abstain from taking additional supplements throughout the testing period, with particular emphasis placed upon protein-based products
- •Participants agree to maintain their normal diet and exercise routine throughout the study
- •BMI between 18.5 to 29.9 kg/m2
- •Participants agree to refrain from consuming alcohol in the 48 hrs leading up to a test day.
- •Willingness to complete questionnaires, records and diaries associated with the study and to complete all clinic visits.
- •Provide voluntary, written, informed consent to participate in the study.
- •Refrain from any sort of exhaustive physical exercise from 48 hrs prior to each test or blood draw
- •Healthy as determined by medical examination at screening visit
- •Willingness to complete food diaries during the study
- •Must have a smart phone to use the Nutritics App
排除标准
- •Alcohol or drug abuse in past year
- •Participation in any other clinical trial in the last 3 months from time of randomisation
- •Volunteer has a known allergy to the test material's active or inactive ingredients
- •Volunteers with unstable medical conditions
- •Any complaints that could interfere with ability to exercise
- •Individuals who are cognitively impaired and/or who are unable to give informed consent
- •Any co-morbidities interacting with mobility or muscle metabolism of the lower limbs (e.g., arthritis, spasticity/rigidity, all neurological disorders and paralysis)
- •Creatine supplements, anticoagulants, corticosteroids, growth hormones,
- •testosterone, immunosuppressants, or exogenous insulin over the previous three months
- •Presence or history of neurological disorders or significant psychiatric illness.
- •Any other condition which in the Investigator's opinion may adversely affect the volunteer's ability to complete the study or its measures or which may pose significant risk to the volunteer
- •Participation in resistance or aerobic exercise within 48 hours of the test days
- •Participation in > 3 High-intensity Exercise sessions per Week
- •Undertake no recovery methods such as sea swims, foam rolling, cryotherapy or undue stretching during Days 14-
- •Have been in contact with a suspected or confirmed case of Covid-19 in the previous 14 days
- •Are Hepatitis A or B positive, HIV positive or have had a sexual partner who is infected with hepatitis or HIV
结局指标
主要结局
Change in strength recovery
时间窗: Two days
Change in strength recovery post-resistance exercise as measured by peak torque from an isokinetic leg extension strength test between groups, ELIOTM and Placebo, at day 16 and day 17.
次要结局
- Alterations in muscle marker IL-6(Three days)
- Alterations in muscle marker CRP(Three days)
- Alterations in muscle marker LDH(Three days)
- Alterations in muscle marker MB(Three days)
- Alterations in muscle marker Acylcarnitine(Three days)
- Alterations in muscle marker TNF-α(Three days)
- Alterations in muscle marker NAD+(Three days)
- Alteration in CK(Three days)
- Alterations in muscle marker FFA(Three days)