Mood, Quality of Life
Conditions
Keywords
Multivitamin, Eurycomalongifoliawater extract, Quality of Life, Mood
Brief summary
A phase II randomized, placebo controlled study evaluating the efficacy of Eurycomalongifoliawater extract (Physta®)+Multivitamin on quality of life and mood on 86 healthy adults over a 24 week supplementation period.
Interventions
DIETARY_SUPPLEMENTPlacebo
DIETARY_SUPPLEMENTMultivitamin
DIETARY_SUPPLEMENTEurycomalongifoliawater extract (Physta®)
Sponsors
Biotropics Malaysia Berhad
KGK Science Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects ≥ 25 and ≤ 65 years of age. * Body mass index (BMI) ≥ 18 and ≤30 kg/m2. * Subjects must be employed in a job/position that has some degree of responsibility such that they experience a mid-level of stress at work. * Subjects with a score of ≤ 18 in the Tension subscale and a score of ≤ 14 in the Fatigue subscale of the POMS Questionnaire. * Judged by the Investigator to be in general good health on the basis of medical history. * Females of child-bearing potential must agree to use appropriate birth control methods during the study. * Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator * Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator
Exclusion criteria
* Subjects with any history of immune system disorder or auto-immune disorder including but not limited to the following: \*AIDS, HIV, Ankylosing Spondylitis, Chronic Fatigue Syndrome, CREST syndrome, Crohn's disease, Dermatomyositis, Fibromyalgia, Grave's disease, Hashimoto's Thyroiditis, Lupus, Multiple Sclerosis, Myasthenia Gravis, Pernicious Anemia, PolyarteritisNodosa, Primary Biliary Cirrhosis, Psoriasis, Reynaud's Syndrome, Rhematoid Arthritis, Sarcoidosis, Scleroderma, Sjogren's Syndrome, Temporal Arthritis, Ulcerative Colitis, and Vitiligo * Use of any immunosuppressive drugs in the last 12 months (including steroids or biologics) * Any significant GI condition that would severely interfere with the evaluation of the study product including but not limited to inflammatory bowel disease (Ulcerative Colitis or Chron's), history of frequent diarrhea, history of surgery for weight loss (including gastric bypass or lapband), history of perforation of the stomach or intestines, gastroparesis, clinically important lactose intolerance * Any active infection, or infection in the last month requiring antibiotics, antiviral medication, or hospitalization History or presence of cancer in the prior two years, except for non-melanoma skin cancer. * Subjects with a history of seizure * Recent history of (within 12 months) or strong potential for alcohol or substance abuse. * Participation in a clinical study with exposure to any non-registered drug product within 30 days prior. * Subject who are using herbal products containing androgenic/anxiolytic activity within 30 days (one month washout is allowed) * Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk. Including subjects who are Bed or wheelchair-bound * Untreated or unstable Hypothyroidism * Subjects with active eating disorder including anorexia nervosa, bulimia, and/or obsessive compulsive eating disorders * Central Neurological disorders including but not limited to Spinal cord injuries, multiple sclerosis, Parkinson's disease * Pregnant, lactating, planning to become pregnant or unwilling to use adequate contraception during the duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in quality of life after 24 weeks of supplementation with study product, measured using the SF-12 Quality of Life Questionnaire | 24 Week |
| The change in mood after 24 weeks of supplementation with study product, measured using the POMS Questionnaire | 24 week |
Secondary
| Measure | Time frame |
|---|---|
| The change in stress after 24 weeks of supplementation with study product, measured using the Multi-Modal Stress Questionnaire | 24 weeks |
| The change in fasting AM Cortisol levels after 24 weeks of supplementation with study product. | 24 weeks |
Other
| Measure | Time frame |
|---|---|
| The change in lipid panel results after 24 weeks of supplementation with study product | 24 weeks |
| The change in CBC levels after 24 weeks of supplementation with study product | 24 weeks |
| The change in free testosterone results after 24 weeks of supplementation with study product | 24 weeks |
| The change in total testosterone results after 24 weeks of supplementation with study product | 24 weeks |
| The change in CMP results after 24 weeks of supplementation with study product | 24 weeks |
| The change in urinalysis results after 24 weeks of supplementation with study product | 24 weeks |
| The number of adverse events reported after 24 weeks of supplementation with study product | 24 weeks |
Outcome results
None listed