Whey Protein and Adaptogenic Supplementation in Physically Active Males

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-45
SponsorSports Performance and Applied Research in Trials and Analysis

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Whey proteinActive comparator 1 intervention
Group B: Whey Protein + Adaptogenic BlendExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

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