- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07594444
Whey Protein and Adaptogenic Supplementation in Physically Active Females
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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
East Sussex
-
Brighton, East Sussex, Storbritannien
- Rekrytering
- Strength and Nutrition Ltd
-
Kontakt:
- Olivia C Coope, PhD(c)
- Telefonnummer: 07882461098
- E-post: livcwalker@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
Andra namn:
|
|
Experimentell: 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.
|
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.
Andra namn:
|
|
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 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.
Andra namn:
|
|
Aktiv komparator: 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.
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Salivary Cortisol Concentration
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Handgrip Strength
Tidsram: 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
Tidsram: 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
Tidsram: Baseline and Week 6
|
Change in gastrointestinal symptoms and digestive comfort assessed using a gastrointestinal distress questionnaire.
|
Baseline and Week 6
|
|
Dietary Intake
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
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-001
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