Muscle Strength Recovery, Recovery, Recovery Following Exercise, Sports Nutrition, Sports Nutritional Sciences
Conditions
Keywords
whey protein, ashwagandha, physically active males, sports supplement, adaptogens, exercise, sports nutrition
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTWhey protein
Participants will consume a whey protein supplement for 6 weeks. The supplement will be provided in identical blank tubs. Participants will be instructed to maintain their usual diet and training habits throughout the intervention period.
DIETARY_SUPPLEMENTDietary Supplement: Whey Protein With Adaptogenic Blend
Participants will consume a whey protein supplement containing ashwagandha KSM-66® root extract (600 mg) for 6 weeks. Supplements will be provided in identical blank tubs. Participants will maintain usual diet and training habits during the study.
Sponsors
Sports Performance and Applied Research in Trials and Analysis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
Participants will be randomly assigned to 1 of 2 parallel groups: whey protein or whey protein with adaptogenic blend. Participants will remain in their assigned group for the full 6-week intervention period. Baseline and post-intervention assessments will be conducted to compare changes between groups and over time.
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Cortisol Concentration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Handgrip Strength | Time Frame: Baseline and Week 6 | Change in maximal handgrip strength measured using a CAMRY dynamometer from baseline to post-intervention. |
| Upper Body Muscular Endurance | Time Frame: Baseline and Week 6 | Change in upper body muscular endurance assessed using the 90-degree push-up test protocol from baseline to post-intervention. |
| Perceived Recovery and Wellbeing | Time Frame: Baseline and Week 6 | Participants will complete the Hooper Index Questionnaire, which assesses four domains: sleep quality, fatigue, stress, and muscle soreness. Each domain is rated on a 10-point Likert scale ranging from 1 to 10, with total scores ranging from 4 to 40. Higher scores indicate poorer wellbeing and recovery status, whereas lower scores indicate better perceived wellbeing and recovery. |
| Salivary DHEA-S Concentration | Time Frame: Baseline and Week 6 | Salivary DHEA-S concentration will be measured from saliva samples using enzyme-linked immunosorbent assay (ELISA) techniques. Results will be reported in ng/mL. |
| Dietary Intake | Time Frame: Baseline and Week 6 | Dietary intake assessed using a 24-hour dietary recall to evaluate habitual nutritional intake during the study period. |
| Salivary Testosterone Concentration | Time Frame: Baseline and Week 6 | Salivary testosterone concentration will be measured from saliva samples using ELISA. Results will be reported in pg/mL. |
| Salivary Secretory Immunoglobulin A (sIgA) Concentration | Time Frame: Baseline and Week 6 | Salivary secretory immunoglobulin A (sIgA) concentration will be measured from saliva samples using ELISA. Results will be reported in µg/mL. |
| Salivary C-reactive Protein Concentration | Time Frame: Baseline to Week 6 | Salivary C-reactive protein will be measured from saliva samples using ELISA. Results will be reported in pg/mL. |
Countries
United Kingdom
Contacts
CONTACTAlex L Levington, PhD(c)
STUDY_DIRECTOROlivia C Coope, PhD(c)
Sports Performance and Applied Research in Trials and Analysis
Outcome results
None listed