None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 120 men aged 40 to 65 years experiencing self-reported stress and fatigue will be randomly assigned to receive Shatavari extract 300 mg plus BioPerine 5 mg, Shatavari extract 500 mg, or placebo once daily for 8 weeks. Changes in self-reported stress, fatigue, mood, sleep, and interest in sexual activity will be assessed over time. Changes in hand grip strength, heart rate variability, bioimpedance phase angle, testosterone, and high-sensitivity C-reactive protein will also be examined.
Interventions
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.
Sponsors
Clinical Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
40 Years to 65 Years
Healthy volunteers
No
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.
Exclusion criteria
1. Clinically significant infection that has not resolved for at least 1 month before the screening visit 2. Has a recently diagnosed or unmanaged medical condition, including but not limited to diabetes, hypertension, cardiovascular disease, gallbladder disease, autoimmune disease, renal disease, endocrine disease, or cancer/ malignancy 3. Has a psychiatric disorder (other than mild-to-moderate depression and/or anxiety), or a neurological condition/ disease, including but not limited to Parkinson’s or Alzheimer’s disease 4. Regular medication intake, including but not limited to anticonvulsants, benzodiazepines, opioids, corticosteroids, or immunosuppressants. 5. In the last 4 weeks before screening, commenced or changed pharmaceutical medications or has an expectation to change during the study period. 6. In the last 4 weeks before screening, commenced or changed over-the-counter supplements that may affect the treatment outcomes 7. Any significant surgeries over the last year that continue to affect daily function or planned surgery during the study period 8. Alcohol intake greater than 14 standard drinks per week 9. Current or 12-month history of regular illicit drug use 10. Work or home conditions that may impact sleep or energy (e.g., shift worker or regularly waking children) 11. Participation in any other clinical trial in the last 4 weeks
Outcome results
None listed