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Whey Protein and Adaptogenic Supplementation in Physically Active Females

3 giugno 2026 aggiornato da: Olivia Charlotte Coope, Sports Performance and Applied Research in Trials and Analysis

Whey Protein and Adaptogenic Herb Supplementation in Physically Active Females: A Randomised Controlled Trial

The goal of this clinical trial is to learn whether whey protein or plant protein supplements, with or without an adaptogenic herb blend, can improve strength, recovery, stress, and wellbeing in active females. The adaptogenic blend contains ashwagandha root extract and shatavari root extract.

The main questions the study aims to answer are:

  • Do whey protein and plant protein supplements improve muscle strength and recovery in physically active females?
  • Does adding ashwagandha and shatavari improve stress, recovery, sleep, and wellbeing compared with protein alone?
  • Are there differences between whey protein and plant protein when combined with the adaptogenic blend?

Researchers will compare four supplement groups:

  • Whey protein
  • Whey protein with ashwagandha and shatavari
  • Plant protein
  • Plant protein with ashwagandha and shatavari

Participants will:

  • Take their assigned supplement daily for 6 weeks
  • Attend 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 females aged 18 to 45 years who regularly participate in structured training.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Regno Unito
    • East Sussex
      • Brighton, East Sussex, Regno Unito
        • Reclutamento
        • Strength and Nutrition Ltd
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • Female, 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

Exclusion Criteria:

  • Pregnant, breastfeeding, or planning pregnancy during the study period
  • Known allergy or sensitivity to dairy, pea protein, pumpkin seed, chia seed, ashwagandha, shatavari, or nightshades
  • Current use of prescribed medication that may interact with the supplements
  • Thyroid disorders, autoimmune conditions, hormone-sensitive conditions, or other medical conditions that may be affected by supplementation
  • Diagnosed eating disorder or condition affecting protein metabolism
  • Current musculoskeletal injury preventing participation in testing
  • Current use of other protein supplements or adaptogens

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Whey Protein + Adaptogenic Blend
Participants will consume a whey protein supplement containing ashwagandha KSM-66® (250 mg) and shatavari SRI-81™ (300 mg) daily for 6 weeks. Assessments will be conducted at baseline and post-intervention.
Integratore alimentare: Whey Protein With Adaptogenic Blend
Participants will consume a whey protein supplement containing ashwagandha KSM-66® root extract (250 mg) and shatavari SRI-81™ root extract (300 mg) daily for 6 weeks. Supplements will be provided in identical blank tubs. Participants will maintain usual diet and training habits during the study.
Altri nomi:
  • Ashwagandha and Shatavari Whey Protein
  • Whey Protein Plus Adaptogens
Sperimentale: Plant Protein + Adaptogenic Blend
Participants will consume a plant-based protein supplement containing ashwagandha KSM-66® (250 mg) and shatavari SRI-81™ (300 mg) daily for 6 weeks. Assessments will be conducted at baseline and post-intervention.
Integratore alimentare: Plant Protein With Adaptogenic Blend
Participants will consume a plant-based protein supplement containing ashwagandha KSM-66® root extract (250 mg) and shatavari SRI-81™ root extract (300 mg) daily for 6 weeks. Supplements will be provided in identical blank tubs. Participants will maintain usual diet and training habits during the study.
Altri nomi:
  • Plant Protein Plus Adaptogens
  • Ashwagandha and Shatavari Plant Protein
Comparatore attivo: 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.
Integratore alimentare: Whey protein
Participants will consume a whey protein supplement daily 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.
Altri nomi:
  • Grass-Fed Whey Protein
  • Whey Protein Powder
Comparatore attivo: Plant protein
Participants will consume a plant-based 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.
Integratore alimentare: Plant Protein Supplement
Participants will consume a plant-based protein supplement daily 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.
Altri nomi:
  • Plant-Based Protein
  • Vegan Protein Supplement

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Salivary Cortisol Concentration
Lasso di tempo: Baseline and Week 6
Change in salivary cortisol concentration from baseline to post-intervention following 6 weeks of whey protein or plant protein supplementation with or without an adaptogenic herb blend containing ashwagandha KSM-66® and shatavari SRI-81™. Results will be reported in ng/mL.
Baseline and Week 6

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Handgrip Strength
Lasso di tempo: Baseline and Week 6
Change in maximal handgrip strength measured using a CAMRY dynamometer from baseline to post-intervention.
Baseline and Week 6
Upper Body Muscular Endurance
Lasso di tempo: Baseline and Week 6
Change in upper body muscular endurance assessed using the 90-degree push-up test protocol from baseline to post-intervention.
Baseline and Week 6
Perceived Gastrointestinal Health
Lasso di tempo: Baseline and Week 6
Change in gastrointestinal symptoms and digestive comfort assessed using a gastrointestinal distress questionnaire.
Baseline and Week 6
Dietary Intake
Lasso di tempo: Baseline and Week 6
Dietary intake assessed using a 24-hour dietary recall to evaluate habitual nutritional intake during the study period.
Baseline and Week 6
Perceived Recovery and Wellbeing
Lasso di tempo: 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.
Baseline and Week 6
Salivary DHEA-S Concentration
Lasso di tempo: 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.
Baseline and Week 6
Salivary Oestradiol Concentration
Lasso di tempo: Baseline and Week 6
Salivary oestradiol concentration will be measured from saliva samples using ELISA. Results will be reported in pg/mL.
Baseline and Week 6
Salivary Secretory Immunoglobulin A (sIgA) Concentration
Lasso di tempo: 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.
Baseline and Week 6
Salivary C-reactive Protein Concentration
Lasso di tempo: Baseline to Week 6
Salivary C-reactive protein will be measured from saliva samples using ELISA. Results will be reported in pg/mL.
Baseline to Week 6

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sports Performance and Applied Research in Trials and Analysis

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

12 agosto 2026

Completamento dello studio (Stimato)

20 settembre 2026

Date di iscrizione allo studio

Primo inviato

12 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 maggio 2026

Primo Inserito (Effettivo)

18 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ASH-WHEY-001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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