Whey Protein and Adaptogenic Herb Supplementation in Physically Active Males: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Salivary Cortisol Concentration
研究概览
简要总结
The goal of this clinical trial is to learn whether whey protein, with or without an adaptogenic herb blend, can improve strength, recovery, stress, and wellbeing in active males. The adaptogenic blend contains 600mg ashwagandha root extract.The main questions the study aims to answer are:
Does whey protein improve muscle strength and recovery in physically active males? Does adding ashwagandha to whey protein further improve stress, recovery, sleep, and wellbeing compared with protein alone? Are there differences between whey protein when combined with the adaptogenic blend?
Researchers will compare two supplement groups:
- Whey protein
- Whey protein with ashwagandha
Participants will:
- Take their assigned supplement for 6 weeks
- Attend two testing sessions before and after the intervention
- Complete questionnaires about recovery, sleep, stress, soreness, and digestive health
- Provide saliva samples to measure stress, hormone, immune, and inflammation markers
- Complete muscle strength tests, including handgrip strength and push-up testing
- Complete a 24-hour dietary recall
- The study includes physically active males aged 18 to 45 years who regularly participate in structured training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants and outcome assessors will be blinded to group allocation. Supplements will be provided in identical blank tubs to minimise identification of the assigned intervention. Group allocation codes will be concealed until completion of data collection and primary analyses.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, aged 18-45 years
- •Currently participating in regular structured athletic or physical training (≥3 sessions per week)
- •Free from musculoskeletal injury that would prevent testing
- •Willing to maintain usual diet and training habits during the study
- •Not currently using protein supplements or adaptogenic supplements
- •Signing of informed consent form
排除标准
- •Known allergy or sensitivity to dairy, ashwagandha or nightshades
- •Current use of prescribed medication that may interact with the supplements
- •Thyroid disorders, autoimmune conditions, hormone-sensitive conditions, or other medical conditions
- •Diagnosed eating disorder or condition affecting protein metabolism
- •Current musculoskeletal injury preventing participation in testing
- •Current use of other protein supplements or adaptogens
- •No signing of informed consent form
研究组 & 干预措施
Whey Protein + Adaptogenic Blend
Participants will consume a whey protein supplement containing ashwagandha KSM-66® (600 mg) for 6 weeks. Assessments will be conducted at baseline and post-intervention.
干预措施: Dietary Supplement: Whey Protein With Adaptogenic Blend (Dietary Supplement)
结局指标
主要结局
Salivary Cortisol Concentration
时间窗: Time Frame: Baseline and Week 6
Change in salivary cortisol concentration from baseline to post-intervention following 6 weeks of whey protein supplementation with or without an adaptogenic herb blend containing ashwagandha KSM-66®. Results will be reported in ng/mL.
次要结局
- Dietary Intake(Time Frame: Baseline and Week 6)
- Handgrip Strength(Time Frame: Baseline and Week 6)
- Upper Body Muscular Endurance(Time Frame: Baseline and Week 6)
- Perceived Recovery and Wellbeing(Time Frame: Baseline and Week 6)
- Salivary DHEA-S Concentration(Time Frame: Baseline and Week 6)
- Salivary Testosterone Concentration(Time Frame: Baseline and Week 6)
- Salivary Secretory Immunoglobulin A (sIgA) Concentration(Time Frame: Baseline and Week 6)
- Salivary C-reactive Protein Concentration(Time Frame: Baseline to Week 6)
研究者
Olivia Charlotte Coope
PhD(c)
Sports Performance and Applied Research in Trials and Analysis