Whey Protein and Adaptogenic Supplementation in Physically Active Females
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorSports Performance and Applied Research in Trials and Analysis
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Whey protein
Dietary supplementParticipants 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.
Whey Protein With Adaptogenic Blend
Dietary supplementParticipants 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.
Plant Protein Supplement
Dietary supplementParticipants 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.
Plant Protein With Adaptogenic Blend
Dietary supplementParticipants 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.
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Whey proteinActive comparator 1 intervention
Group B: Whey Protein + Adaptogenic BlendExperimental treatment 1 intervention
Group C: Plant proteinActive comparator 1 intervention
Group D: Plant Protein + Adaptogenic BlendExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Salivary Cortisol Concentration
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 6Secondary outcomes
1
Handgrip Strength
Change in maximal handgrip strength measured using a CAMRY dynamometer from baseline to post-intervention.
Time frame
Baseline and Week 62
Upper Body Muscular Endurance
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 63
Perceived Recovery and Wellbeing
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 64
Salivary DHEA-S Concentration
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 6Sponsors and contacts
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Source ClinicalTrials.gov