- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07716904
Whey Protein and Adaptogenic Supplementation in Physically Active Males
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.
Przegląd badań
Status
Warunki
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Alex L Levington, PhD(c)
- Numer telefonu: 07882461098
- E-mail: alex@strengthandnutrition.co.uk
Lokalizacje studiów
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East Sussex
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Brighton, East Sussex, Zjednoczone Królestwo
- Rekrutacyjny
- Strength and Nutrition Ltd
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Kontakt:
- Olivia C Coope, PhD(c)
- Numer telefonu: 07882461098
- E-mail: drocc1@gmail.com
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny 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.
|
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.
Inne nazwy:
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Eksperymentalny: 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.
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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.
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Salivary Cortisol Concentration
Ramy czasowe: Time Frame: Baseline and Week 6
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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.
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Time Frame: Baseline and Week 6
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Handgrip Strength
Ramy czasowe: Time Frame: Baseline and Week 6
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Change in maximal handgrip strength measured using a CAMRY dynamometer from baseline to post-intervention.
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Time Frame: Baseline and Week 6
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Upper Body Muscular Endurance
Ramy czasowe: Time Frame: Baseline and Week 6
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Change in upper body muscular endurance assessed using the 90-degree push-up test protocol from baseline to post-intervention.
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Time Frame: Baseline and Week 6
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Perceived Recovery and Wellbeing
Ramy czasowe: Time Frame: Baseline and Week 6
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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.
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Time Frame: Baseline and Week 6
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Salivary DHEA-S Concentration
Ramy czasowe: Time Frame: Baseline and Week 6
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Salivary DHEA-S concentration will be measured from saliva samples using enzyme-linked immunosorbent assay (ELISA) techniques.
Results will be reported in ng/mL.
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Time Frame: Baseline and Week 6
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Dietary Intake
Ramy czasowe: 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.
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Time Frame: Baseline and Week 6
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Salivary Testosterone Concentration
Ramy czasowe: Time Frame: Baseline and Week 6
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Salivary testosterone concentration will be measured from saliva samples using ELISA.
Results will be reported in pg/mL.
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Time Frame: Baseline and Week 6
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Salivary Secretory Immunoglobulin A (sIgA) Concentration
Ramy czasowe: Time Frame: Baseline and Week 6
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Salivary secretory immunoglobulin A (sIgA) concentration will be measured from saliva samples using ELISA.
Results will be reported in µg/mL.
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Time Frame: Baseline and Week 6
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Salivary C-reactive Protein Concentration
Ramy czasowe: Time Frame: Baseline to Week 6
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Salivary C-reactive protein will be measured from saliva samples using ELISA.
Results will be reported in pg/mL.
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Time Frame: Baseline to Week 6
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Współpracownicy i badacze
Śledczy
- Dyrektor Studium: Olivia C Coope, PhD(c), Sports Performance and Applied Research in Trials and Analysis
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- ASH-WHEY-002
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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