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Whey Protein and Adaptogenic Supplementation in Physically Active Males

21. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Storbritannia
    • East Sussex
      • Brighton, East Sussex, Storbritannia
        • Rekruttering
        • Strength and Nutrition Ltd
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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.
Kosttilskudd: 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 navn:
  • Grass-Fed Whey Protein
  • Whey Protein Powder
Eksperimentell: 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.
Kosttilskudd: 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 navn:
  • Whey Protein Plus Adaptogens
  • Ashwagandha Whey Protein

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sports Performance and Applied Research in Trials and Analysis

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

20. juli 2026

Primær fullføring (Antatt)

20. september 2026

Studiet fullført (Antatt)

1. oktober 2026

Datoer for studieregistrering

Først innsendt

16. juli 2026

Først innsendt som oppfylte QC-kriteriene

16. juli 2026

Først lagt ut (Faktiske)

21. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ASH-WHEY-002

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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