None listed
Conditions
Brief summary
In this randomised, double-blind, parallel-group, placebo-controlled study, 120 overweight/ mildly obese adults (body mass index between 25 and 35 kg/m2) experiencing high stress and low energy will be randomly assigned into one of two groups comprising either a twice-daily intake of capsules containing a Withania somnifera (Ashwagandha) extract or a placebo for 12 weeks. We will assess changes in stress, fatigue, quality of life, and interest in sexual activity using several self-report questionnaires. Changes in sex hormone concentrations, oxidative stress, inflammation, blood glucose regulation will be assessed from a venous blood collection. A blood sample will also be collected to measure changes in liver and renal function, and complete blood count. Changes in heart rate variability will also be assessed over time. Finally, changes in strength will be determined using a hand-held dynamometer, which is an indicator of overall body strength. It is hypothesised that, compared to the placebo, ashwagandha supplementation will be associated with a greater reduction in stress, improvements in energy, quality of life, and endocrine/ physiological markers.
Interventions
Ashwagandha extract (1 capsule taken orally, twice daily with or without food, delivering 400 mg a day for 12 weeks)
Adherence to capsule intake will be monitored through a mobile phone app and capsule return and count.
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
All
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1) Healthy males and females aged between 40 and 75 years 2) Subjective report of low energy by answering ‘yes’ to the following question: Do you experience low energy or fatigue? 3) Currently experiencing high stress (as determined by a PSS scale score of 14 or higher) 4) A score of 9 or more on the PROMIS-29 fatigue subscale score 5) Stressor/anxiety has been present for greater than a month 6) Non-smoker 7) BMI between 25 and 35 kg/m2 8) Medication free over the previous 3 months 9) No plan to commence new treatments over the study period 10) No plan to change diet or physical activity or other significant lifestyle changes over the study period 11) Understand, willing, and able to comply with all study procedures 12) Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Exclusion criteria
1) Anticipated major stressor, change or medical procedure occurring during the study period likely to affect psychological or physical status 2) Blood profile (comprising complete blood count, liver function test, renal function test, and thyroid-stimulating hormone) containing elevated markers suggestive of a clinical condition/ disease and requiring further medical assessment. 3) Suffering from a diagnosed medical condition including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, a gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, autoimmune disease, endocrine disease, renal disease, hepatic disease, genital anatomical deformities, abnormal secondary sexual characteristics, spinal cord injury, benign prostatic hypertrophy, acute genitourinary disorder or history of genital surgery, acute or chronic pain condition, or cancer/malignancy 4) Diagnosis of neurological or psychiatric conditions including but not limited to: psychiatric disorder (other than mild-to-moderate depression or anxiety), neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury 5) Diagnosed erectile dysfunction or any physical disability that may limit sexual function 6) Taking vitamins or herbal supplements that are reasonably expected to influence study measures 7) Current or 12-month history of illicit drug abuse 8) Regular medication intake including but not limited to anticholinergics, acetylcholinesterase inhibitors, testosterone replacement therapy, levodopa, calcipotriene, or steroid medications 9) Change in medication in the last 3 months or an expectation to change during the study duration 10) Alcohol intake greater than 14 standard drinks per week 11) Pregnant women, women who are breastfeeding or women who intended to fall pregnant. 12) Any significant surgeries over the last year 13) History of hypersensitivity to herbs, spices, or dietary supplement 14) Planned major lifestyle change in the next 3 months 15) Participation in any other clinical trial in the last 3 months
Outcome results
None listed