Management of stress, fatigue, and sleep disturbances in healthy adults Mental and Behavioural Disorders
Conditions
Interventions
Participants will be randomly assigned in a 1:1 ratio to receive either 500 mg of mushroom blend supplement or 500 mg of placebo, administered as one oral capsule daily after a meal for 12 weeks. Rand
Sponsors
Nexus Wise Sdn. Bhd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 22-55 years 2. Able to give informed consent 3. Agreed to come for follow-up 4. Body mass index (BMI) between 20 and 35 kg/m2 Primary objective (stress & fatigue): Suffering from at least three of the symptoms of stress: 1. Headache 2. Palpitation at rest 3. Abnormal perception of hearing 4. Blurring of vision 5. Forgetfulness 6. Sexual problems of recent origin 7. Frequent GI symptoms, lack of appetite, or dislike of even favourite food 8. Abnormal movements of the upper limb, tics, tremors, scratching 9. Abnormal sensory perceptions, particularly of the lower limbs and face 10. Quarrelsome behaviour with later realisation of a mistake 11. Frequent feeling of exhaustion or overwork 12. Frequent sleep problems of recent origin 13. Avoidance of even familiar people 14. Missing appointments for other things less important Participants showed an anxiety State-Trait-Anxiety Inventory (STAI) score of more than 40 and less than 60 at the screening visit. The cutoff value of STAI to detect clinical symptoms for the state anxiety scale has been suggested as 39-40. [Stress] Score 14 or higher on the Perceived Stress Scale (PSS) and give a rating of 3 or higher on at least one of the first 5 questions of the Insomnia Symptoms Questionnaire (ISQ). [Stress + Sleep] Chronic fatigue symptoms assessed as = 5 on the NASs for ‘postexertional malaise lasting more than 24 hours’, ‘substantial impairment in short-term memory and concentration’, and ‘unrefreshing sleep’ [Fatigue] MFI-20 score = 7 for the subscales ‘general fatigue’, ‘physical fatigue’, ‘mental fatigue [Fatigue] Secondary objective (Sleep): 1. Score 14 or higher on the Perceived Stress Scale (PSS) and give a rating of 3 or higher on at least one of the first 5 questions of the Insomnia Symptoms Questionnaire (ISQ). [Stress + Sleep] 2. Participants must not have any sleep disorders and must have Pittsburgh Sleep Quality Index scores of 5 points or lower [Sleep]
Exclusion criteria
Exclusion criteria: 1. History of significant cardiac, hepatic, renal, brain, or blood-allergic disease 2. Physical disabilities 3. Taking allopathic or herbal medicines or participating in any other clinical trial 4. Pregnant/breastfeeding 5. Employed in night shift work, rotational shift work, or were experiencing external factors that may affect sleep patterns 6. People experiencing a sleep disorder other than moderate insomnia (eg, sleep apnoea, periodic limb movement disorder, restless legs syndrome) 7. Consuming more than 3 cups of coffee per day (or equivalent caffeine intake from other caffeinated drinks, e.g., tea, energy drinks) 8. Alcohol consumption greater than 14 standard drinks per week 9. Taking pharmaceutical medications or natural supplements that may affect sleep quality 10. Receiving nonpharmacological treatment for sleep disorders (eg, cognitive behavioural therapy, relaxation therapy) 11. Current or 12-month history of illicit drug use 12. Recently-diagnosed or unmanaged 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, endocrine disease, neurological disease (Parkinson's, Alzheimer's disease, intracranial haemorrhage, head or brain injury), or acute or chronic pain affecting sleep 13. A medical history of gastrointestinal diseases (oesophageal achalasia, oesophageal stricture, or Crohn’s disease) or operations (other than simple appendectomy or hernia surgeries) that may affect drug absorption 14. Hypothyroid condition 15. Participant on immunosuppressant (i.e., steroids) 16. Participants with intense workout routine daily 17. Use of immune-modifying medications or dietary supplements affecting the immune system (at least 2 weeks of washing period for inclusion)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perceived stress is measured using the Perceived Stress Scale (PSS) and the State-Trait Anxiety Inventory (STAI) at baseline, week 6, and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fatigue is measured using the Multidimensional Fatigue Inventory (MFI-20) and the National Academy of Sciences (NASs) chronic fatigue symptom assessment at baseline, week 6, and week 12 2. Sleep quality is measured using the Pittsburgh Sleep Quality Index (PSQI) and the Insomnia Symptoms Questionnaire (ISQ) at baseline, week 6, and week 12 | — |
Countries
Malaysia
Contacts
Public ContactLe Jie Lee
Outcome results
None listed