Whey Protein and Adaptogenic Supplementation in Physically Active Males
21 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Alex L Levington, PhD(c)
- Número de teléfono: 07882461098
- Correo electrónico: alex@strengthandnutrition.co.uk
Ubicaciones de estudio
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East Sussex
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Brighton, East Sussex, Reino Unido
- Reclutamiento
- Strength and Nutrition Ltd
-
Contacto:
- Olivia C Coope, PhD(c)
- Número de teléfono: 07882461098
- Correo electrónico: drocc1@gmail.com
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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.
|
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.
Otros nombres:
|
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Experimental: 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.
|
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Salivary Cortisol Concentration
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Handgrip Strength
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Salivary DHEA-S Concentration
Periodo de tiempo: 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
|
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Dietary Intake
Periodo de tiempo: Time Frame: Baseline and Week 6
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Dietary intake assessed using a 24-hour dietary recall to evaluate habitual nutritional intake during the study period.
|
Time Frame: Baseline and Week 6
|
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Salivary Testosterone Concentration
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Director de estudio: Olivia C Coope, PhD(c), Sports Performance and Applied Research in Trials and Analysis
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
20 de julio de 2026
Finalización primaria (Estimado)
20 de septiembre de 2026
Finalización del estudio (Estimado)
1 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
16 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
16 de julio de 2026
Publicado por primera vez (Actual)
21 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ASH-WHEY-002
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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