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Whey Protein and Adaptogenic Supplementation in Physically Active Males

16. juli 2026 opdateret af: Olivia Charlotte Coope, Sports Performance and Applied Research in Trials and Analysis

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Det Forenede Kongerige
    • East Sussex
      • Brighton, East Sussex, Det Forenede Kongerige
        • Rekruttering
        • Strength and Nutrition Ltd
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Kosttilskud: 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.
Andre navne:
  • Grass-Fed Whey Protein
  • Whey Protein Powder
Eksperimentel: 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.
Kosttilskud: 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.
Andre navne:
  • Whey Protein Plus Adaptogens
  • Ashwagandha Whey Protein

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Salivary Cortisol Concentration
Tidsramme: 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.
Time Frame: Baseline and Week 6

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Handgrip Strength
Tidsramme: Time Frame: Baseline and Week 6
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
Tidsramme: 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.
Time Frame: Baseline and Week 6
Perceived Recovery and Wellbeing
Tidsramme: 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.
Time Frame: Baseline and Week 6
Salivary DHEA-S Concentration
Tidsramme: 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.
Time Frame: Baseline and Week 6
Dietary Intake
Tidsramme: Time Frame: Baseline and Week 6
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
Tidsramme: Time Frame: Baseline and Week 6
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
Tidsramme: 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.
Time Frame: Baseline and Week 6
Salivary C-reactive Protein Concentration
Tidsramme: 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.
Time Frame: Baseline to Week 6

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sports Performance and Applied Research in Trials and Analysis

Efterforskere

  • Studieleder: Olivia C Coope, PhD(c), Sports Performance and Applied Research in Trials and Analysis

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. juli 2026

Primær færdiggørelse (Anslået)

20. september 2026

Studieafslutning (Anslået)

1. oktober 2026

Datoer for studieregistrering

Først indsendt

16. juli 2026

Først indsendt, der opfyldte QC-kriterier

16. juli 2026

Først opslået (Faktiske)

21. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ASH-WHEY-002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Betingelser

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Kosttilskud

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Placeringer

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