Strength and Nutrition Ltd
Brighton, East Sussex, United Kingdom
Location status: Recruiting
NCT Number: NCT07594444
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.
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Not applicable
Brighton, East Sussex, United Kingdom
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Grass-Fed Whey Protein, Whey Protein Powder
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.
Other names: Ashwagandha and Shatavari Whey Protein, Whey Protein Plus Adaptogens
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.
Other names: Plant-Based Protein, Vegan Protein Supplement
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.
Other names: Plant Protein Plus Adaptogens, Ashwagandha and Shatavari Plant Protein
Time frame: 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.
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
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
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 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
Change in gastrointestinal symptoms and digestive comfort assessed using a gastrointestinal distress questionnaire.
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 oestradiol 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 will be measured from saliva samples using ELISA. Results will be reported in µg/mL.
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.
Sports Performance and Applied Research in Trials and Analysis
Network
Whey Protein and Adaptogenic Herb Supplementation in Physically Active Females: A Randomised Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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