A randomised, double-blind, placebo-controlled study to evaluate the efficacy of a Shatavari (Asparagus racemosus) extract in men experiencing self-reported stress and fatigue

INTERVENTION: Randomised and equal allocation to either (1) Shatavari (Asparagus racemosus) extract (500 mg ‐ 1 capsule taken orally, once daily, after breakfast for 8 weeks), or (2) Shatavari (Asparagus racemosus) extract (300 mg) + Bioperine (5mg) (1 capsule taken orally, once daily, after breakfast for 8 weeks). Adherence to capsule intake will be measured by a count of capsules returned at week 8. CONDITION: Alternative and Complementary Medicine ‐ Herbal remedies Mental Health ‐ Other mental health disorders Stress;Fatigue;Sleep disturbance; ; Stress ; Fatigue ; Sleep disturbance PRIMARY OUTCOME: Fatigue[PROMIS Fatigue Score Day 0 (the day before commencement of intervention), 28 and 56 (primary endpoint) post‐intervention commencement] Stress[Perceived Stress Scale ‐ 4: total score Day 0 (the day before commencement of intervention), 28 and 56 (primary endpoint) post‐intervention commencement] INCLUSION CRITERIA: 1. Males aged 40 to 65 years. 2. Experiencing self‐reported stress as indicated by a Perceived Stress Scale‐4 total score of at least 6 at screening. 3. Experiencing self‐reported fatigue as indicated by a PROMIS Fatigue raw score of at least 9 at screening. 4. BMI between 18 and 35 kg/m2. 5. Willing to maintain pre‐screening diet, exercise, and supplement regimen during the study period. 6. Non‐smoker. 7. No plan to commence new treatments over the study period. 8. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial. SECONDARY OUTCOME: Anxiety[PROMIS Anxiety Score Day 0 (the day before commencement of intervention), 28 and 56 post‐intervention commencement] Bioimpedance phase angle [Bioimpedance phase angle assessed using a bioelectrical impedance analysis scale Days 0 (the day before commencement of intervention) and 56 post‐intervention commencement] Depressive symptoms[PROMIS Depression Score Day 0 (the day before commencement of intervention), 28 and 56 post‐intervention commencement] Fatigue[Daily rating of overall fatigue levels for the day (rated from 1 to 10) sent to participants' mobile phones every morning Day 0 (pre‐commencement of intervention) and every day for 56 days (post‐intervention commencement)] Free testosterone[Blood analysis Day 0 (the day before commencement of intervention) and 56 post‐intervention commencement] General wellbeing[Patient Global Impression of Change in General Wellbeing Day 28 and 56 days post‐intervention commencement] Grip strength[Hand grip strength assessed using a digital hand dynamometer. Days 0 (the day before commencement of intervention) and 56 post‐intervention commencement] Heart rate variability[Resting heart rate variability assessed using a Polar H10 heart rate sensor chest monitor. HRV will be calculated using prespecified time‐domain and/or frequency‐domain indices. Days 0 (the day before commencement of intervention) and 56 post‐intervention commencement] High‐sensitivity C‐reactive protein[Blood analysis Day 0 (the day before commencement of intervention) and 56 post‐intervention commencement] Interest in Sexual Activity[PROMIS Interest in Sexual Activity Score Day 0 (the day before commencement of intervention), 28 and 56 post‐intervention commencement] Sleep Disturbance[PROMIS Sleep Disturbance Score Day 0 (the day before commencement of intervention), 28 and 56 post‐intervention commencement] Stress[Daily rating of overall stress levels for the day (rated from 1 to 10) sent to participants' mobile phones every morning Day 0 (pre‐commencement of intervention) and every day for 56 days (post‐intervention commencement)] Total testosterone[Blood analysis Day 0 (the day before commencement of intervention) and 56 post‐intervention commencement]