- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
East Sussex
-
Brighton, East Sussex, United Kingdom
- Recruiting
- Strength and Nutrition Ltd
-
Contact:
- Olivia C Coope, PhD(c)
- Phone Number: 07882461098
- Email: livcwalker@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 sachets.
Participants will be instructed to maintain their usual diet and training habits throughout the intervention period.
Other Names:
|
|
Experimental: 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 sachets.
Participants will maintain usual diet and training habits during the study.
Other Names:
|
|
Experimental: 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 sachets.
Participants will be instructed to maintain their usual diet and training habits throughout the intervention period.
Other Names:
|
|
Experimental: 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 sachets.
Participants will maintain usual diet and training habits during the study.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Salivary Cortisol Concentration
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™.
|
Baseline and Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Handgrip Strength
Time Frame: 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
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.
|
Baseline and Week 6
|
|
Perceived Recovery and Wellbeing
Time Frame: Baseline and Week 6
|
Change in perceived sleep quality, fatigue, muscle soreness, stress, and recovery measured using the Hooper Index questionnaire.
|
Baseline and Week 6
|
|
Salivary Biomarkers of Stress, Hormonal Status, Immunity, and Inflammation
Time Frame: Baseline and Week 6
|
Changes in salivary DHEA-S, oestradiol, secretory immunoglobulin A (sIgA), interleukin-6 (IL-6), and interleukin-1 beta (IL-1β) concentrations from baseline to post-intervention.
|
Baseline and Week 6
|
|
Perceived Gastrointestinal Health
Time Frame: Baseline and Week 6
|
Change in gastrointestinal symptoms and digestive comfort assessed using a gastrointestinal distress questionnaire.
|
Baseline and Week 6
|
|
Dietary Intake
Time Frame: 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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASH-WHEY-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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