CClinicalTrials.gg
RecruitingNCT07716904Updated Jul 22, 2026

Whey Protein and Adaptogenic Supplementation in Physically Active Males

An interventional study of Whey protein and Dietary Supplement: Whey Protein With Adaptogenic Blend in Sports Nutritional Sciences, Sports Nutrition and Recovery, sponsored by Sports Performance and Applied Research in Trials and Analysis. Recruiting at 1 site in United Kingdom. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by Sports Performance and Applied Research in Trials and Analysis · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.
02

Conditions studied

  • Sports Nutritional Sciences
  • Sports Nutrition
  • Recovery
  • Recovery Following Exercise
  • Muscle Strength Recovery

Browse trials for

Keywords

  • whey protein
  • ashwagandha
  • physically active males
  • sports supplement
  • adaptogens
  • exercise
  • sports nutrition
03

In context

Motor Activity

2,426 studies on the registry are indexed under Motor Activity; 1,161 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 2,118 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

Sports Performance and Applied Research in Trials and Analysis is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

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.

    Also known as: Grass-Fed Whey Protein, Whey Protein Powder

  • 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.

    Also known as: Whey Protein Plus Adaptogens, Ashwagandha Whey Protein

06

What researchers measure

Primary outcomes

  1. 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: Time Frame: Baseline and Week 6

Secondary outcomes

  1. Handgrip Strength

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

    Time frame: Time Frame: Baseline and Week 6

  2. 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: Time Frame: Baseline and Week 6

  3. 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: Time Frame: Baseline and Week 6

  4. 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: Time Frame: Baseline and Week 6

  5. Dietary Intake

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

    Time frame: Time Frame: Baseline and Week 6

  6. Salivary Testosterone Concentration

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

    Time frame: Time Frame: Baseline and Week 6

  7. 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: Time Frame: Baseline and Week 6

  8. 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: Time Frame: Baseline to Week 6

07

Study locations

1 of 1 sites recruiting
  • Strength and Nutrition Ltd
    Brighton, East Sussex, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07716904
Lead sponsor
Sports Performance and Applied Research in Trials and Analysis
Responsible party
Olivia Charlotte Coope (PhD(c), Sports Performance and Applied Research in Trials and Analysis) — Principal investigator
First posted
Jul 21, 2026
Start date
Jul 20, 2026 (estimated)
Primary completion
Sep 20, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Jul 22, 2026

Study contacts

Alex L Levington, PhD(c)
Contact
alex@strengthandnutrition.co.uk
07882461098
Olivia C Coope, PhD(c)
study director · Sports Performance and Applied Research in Trials and Analysis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion