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NCT Number: NCT07716904

Whey Protein and Adaptogenic Supplementation in Physically Active Males

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.

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Key information

Conditions

Sports Nutritional Sciences Behavior Motor Activity Muscle Strength Recovery Recovery Recovery Following Exercise Sports Nutrition

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Strength and Nutrition Ltd

Brighton, East Sussex, United Kingdom

Location status: Recruiting

Location contact

Olivia C Coope, PhD(c)

CONTACT

[email protected]

07882461098

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey Protein

Dietary Supplement

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

Dietary Supplement: Whey Protein With Adaptogenic Blend

Dietary Supplement

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

Primary outcomes

  1. Salivary Cortisol Concentration

    Time frame: 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 outcomes

  1. Handgrip Strength

    Time frame: Time Frame: Baseline and Week 6

    Change in maximal handgrip strength measured using a CAMRY dynamometer from baseline to post-intervention.

  2. Upper Body Muscular Endurance

    Time frame: 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.

  3. Perceived Recovery and Wellbeing

    Time frame: 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.

  4. Salivary DHEA-S Concentration

    Time frame: 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.

  5. Dietary Intake

    Time frame: Time Frame: Baseline and Week 6

    Dietary intake assessed using a 24-hour dietary recall to evaluate habitual nutritional intake during the study period.

  6. Salivary Testosterone Concentration

    Time frame: Time Frame: Baseline and Week 6

    Salivary testosterone concentration will be measured from saliva samples using ELISA. Results will be reported in pg/mL.

  7. Salivary Secretory Immunoglobulin A (sIgA) Concentration

    Time frame: 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.

  8. Salivary C-reactive Protein Concentration

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alex L Levington, PhD(c)

CONTACT

[email protected]

07882461098

Sponsors and collaborators

Lead sponsor

Sports Performance and Applied Research in Trials and Analysis

Network

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 21, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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