Whey Protein and Adaptogenic Supplementation in Physically Active Males

NCT07716904 | Recruiting

• 1 other identifier: ASH-WHEY-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

whey protein; ashwagandha; physically active males; sports supplement; adaptogens; exercise; sports nutrition

Outcome Measures

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: Baseline and Week 6

Secondary Outcomes (8)

• Handgrip Strength

  Time Frame: Baseline and Week 6

• Upper Body Muscular Endurance

  Time Frame: Baseline and Week 6

• Perceived Recovery and Wellbeing

  Time Frame: Baseline and Week 6

• Salivary DHEA-S Concentration

  Time Frame: Baseline and Week 6

• Dietary Intake

  Time Frame: Baseline and Week 6

Study Arms (2)

Whey protein

ACTIVE COMPARATOR

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

Whey Protein + Adaptogenic Blend

EXPERIMENTAL

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

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.

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

Whey protein

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.

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

Whey Protein + Adaptogenic Blend

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sports Performance and Applied Research in Trials and Analysis: lead

Study Sites (1)

Strength and Nutrition Ltd

Brighton, East Sussex, United Kingdom

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Olivia C Coope, PhD(c)

  Sports Performance and Applied Research in Trials and Analysis

  STUDY DIRECTOR

Central Study Contacts

Alex L Levington, PhD(c)

CONTACT

07882461098; alex@strengthandnutrition.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD(c)

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)