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Whey Protein and Adaptogenic Supplementation in Physically Active Females

3 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Reino Unido
    • East Sussex
      • Brighton, East Sussex, Reino Unido
        • Recrutamento
        • Strength and Nutrition Ltd
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Suplemento dietético: 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.
Outros nomes:
  • Ashwagandha and Shatavari Whey Protein
  • Whey Protein Plus Adaptogens
Experimental: 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.
Suplemento dietético: 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.
Outros nomes:
  • Plant Protein Plus Adaptogens
  • Ashwagandha and Shatavari Plant Protein
Comparador Ativo: 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.
Suplemento dietético: 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.
Outros nomes:
  • Grass-Fed Whey Protein
  • Whey Protein Powder
Comparador Ativo: 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.
Suplemento dietético: 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.
Outros nomes:
  • Plant-Based Protein
  • Vegan Protein Supplement

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Salivary Cortisol Concentration
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Handgrip Strength
Prazo: 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
Prazo: 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
Prazo: Baseline and Week 6
Change in gastrointestinal symptoms and digestive comfort assessed using a gastrointestinal distress questionnaire.
Baseline and Week 6
Dietary Intake
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Sports Performance and Applied Research in Trials and Analysis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de julho de 2026

Conclusão Primária (Estimado)

12 de agosto de 2026

Conclusão do estudo (Estimado)

20 de setembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

12 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de maio de 2026

Primeira postagem (Real)

18 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ASH-WHEY-001

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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