- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Alex L Levington, PhD(c)
- Telefonnummer: 07882461098
- E-post: alex@strengthandnutrition.co.uk
Studieorter
-
-
East Sussex
-
Brighton, East Sussex, Storbritannien
- Rekrytering
- Strength and Nutrition Ltd
-
Kontakt:
- Olivia C Coope, PhD(c)
- Telefonnummer: 07882461098
- E-post: drocc1@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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.
|
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.
Andra namn:
|
|
Experimentell: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Salivary Cortisol Concentration
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Handgrip Strength
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Utredare
- Studierektor: Olivia C Coope, PhD(c), Sports Performance and Applied Research in Trials and Analysis
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ASH-WHEY-002
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