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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:
Researchers will compare four supplement groups:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey protein | Active Comparator | 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. |
|
| Whey Protein + Adaptogenic Blend | Experimental | 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. |
|
| Plant protein | Active Comparator | 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. |
|
| Plant Protein + Adaptogenic Blend | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Handgrip Strength | Change in maximal handgrip strength measured using a CAMRY dynamometer from baseline to post-intervention. | Baseline and Week 6 |
| Upper Body Muscular Endurance | Change in upper body muscular endurance assessed using the 90-degree push-up test protocol from baseline to post-intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Strength and Nutrition Ltd | Recruiting | Brighton | East Sussex | United Kingdom |
Individual participant data (IPD) will not be shared with other researchers. Data collected in this study will be anonymised and retained only for the duration of analysis before permanent deletion, in accordance with the study protocol, participant consent, and UK GDPR requirements.
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Participants will be randomly assigned to 1 of 4 parallel groups: whey protein, whey protein with adaptogenic blend, plant protein, or plant protein with adaptogenic blend. Participants will remain in their assigned group for the full 6-week intervention period. Baseline and post-intervention assessments will be conducted to compare changes between groups and over time.
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Participants and outcome assessors will be blinded to group allocation. Supplements will be provided in identical blank tubs to minimise identification of the assigned intervention. Group allocation codes will be concealed until completion of data collection and primary analyses.
|
| Whey Protein With Adaptogenic Blend | Dietary Supplement | 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. |
|
|
| Plant Protein Supplement | Dietary Supplement | 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. |
|
|
| Plant Protein With Adaptogenic Blend | Dietary 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. |
|
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| Baseline and Week 6 |
| 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. | Baseline and Week 6 |
| 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. | Baseline and Week 6 |
| Perceived Gastrointestinal Health | Change in gastrointestinal symptoms and digestive comfort assessed using a gastrointestinal distress questionnaire. | Baseline and Week 6 |
| Dietary Intake | Dietary intake assessed using a 24-hour dietary recall to evaluate habitual nutritional intake during the study period. | Baseline and Week 6 |
| Salivary Oestradiol Concentration | 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 | 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 | Salivary C-reactive protein will be measured from saliva samples using ELISA. Results will be reported in pg/mL. | Baseline to Week 6 |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| C030693 | Ashwagandha |
| D010940 | Plant Proteins |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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