Whey Protein and Adaptogenic Supplementation in Physically Active Males

Whey Protein and Adaptogenic Herb Supplementation in Physically Active Males: A Randomised Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Recovery; Sports Nutritional Sciences; Sports Nutrition; Muscle Strength Recovery; Recovery Following Exercise
• Intervention / Treatment: Dietary supplement: Whey protein; Dietary supplement: Dietary Supplement: Whey Protein With Adaptogenic Blend

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alex L Levington, PhD(c); Phone Number: 07882461098; Email: alex@strengthandnutrition.co.uk

Study Locations

• United Kingdom
  • East Sussex
    • Brighton, East Sussex, United Kingdom
      • Recruiting
      • Strength and Nutrition Ltd
      • Contact: Olivia C Coope, PhD(c); Phone Number: 07882461098; Email: drocc1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Whey protein; Participants will consume a whey protein supplement daily for 6 weeks. Assessments of muscle strength, recovery, stress, wellbeing, dietary intake, and salivary biomarkers will be conducted at baseline and post-intervention.	Dietary supplement: Whey 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.; Other Names: Grass-Fed Whey Protein; Whey Protein Powder
Experimental: 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.	Dietary supplement: Dietary 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.; Other Names: Whey Protein Plus Adaptogens; Ashwagandha Whey Protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary Cortisol Concentration	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.	Time Frame: Baseline and Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handgrip Strength	Change in maximal handgrip strength measured using a CAMRY dynamometer from baseline to post-intervention.	Time Frame: Baseline and Week 6
Upper Body Muscular Endurance	Change in upper body muscular endurance assessed using the 90-degree push-up test protocol from baseline to post-intervention.	Time Frame: Baseline and Week 6
Perceived Recovery and Wellbeing	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.	Time Frame: Baseline and Week 6
Salivary DHEA-S Concentration	Salivary DHEA-S concentration will be measured from saliva samples using enzyme-linked immunosorbent assay (ELISA) techniques. Results will be reported in ng/mL.	Time Frame: Baseline and Week 6
Dietary Intake	Dietary intake assessed using a 24-hour dietary recall to evaluate habitual nutritional intake during the study period.	Time Frame: Baseline and Week 6
Salivary Testosterone Concentration	Salivary testosterone concentration will be measured from saliva samples using ELISA. Results will be reported in pg/mL.	Time Frame: Baseline and Week 6
Salivary Secretory Immunoglobulin A (sIgA) Concentration	Salivary secretory immunoglobulin A (sIgA) concentration will be measured from saliva samples using ELISA. Results will be reported in µg/mL.	Time Frame: Baseline and Week 6
Salivary C-reactive Protein Concentration	Salivary C-reactive protein will be measured from saliva samples using ELISA. Results will be reported in pg/mL.	Time Frame: Baseline to Week 6

Collaborators and Investigators

• Sponsor: Sports Performance and Applied Research in Trials and Analysis
• Investigators: Study Director: Olivia C Coope, PhD(c), Sports Performance and Applied Research in Trials and Analysis

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: exercise; sports nutrition; whey protein; ashwagandha; physically active males; sports supplement; adaptogens
• Additional Relevant MeSH Terms: Behavior; Motor Activity; Amino Acids, Peptides, and Proteins; Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dairy Products; Milk; Dietary Proteins; Milk Proteins; Animal Proteins, Dietary; Whey; Whey Proteins
• Other Study ID Numbers: ASH-WHEY-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared with other researchers. Data collected in this study will be anonymised and retained only for the duration of analysis before permanent deletion, in accordance with the study protocol, participant consent, and UK GDPR requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No