Safety and Potential Symptom Improvement Effects of Long Term Consumption of Plasma Activated Water in Fibromyalgia Patients
Conditions
Brief summary
Fibromyalgia is a chronic syndrome characterized by widespread pain that is commonly observed in pain, rheumatology, or rehabilitation clinics. Previous studies have suggested a fibromyalgia prevalence rate of approximately 2%. Currently, evidence shows that fibromyalgia might be partially associated with increased oxidative stress, caused by mitochondrial abnormalities, genetic abnormalities, and excessive metal intake. Some research teams have experimented with dietary adjustments to control oxidative stress, but the relationship between diet and oxidative stress has not been conclusively confirmed. Plasma-activated water is a method of storing the high-energy benefits of water and effectively utilizing its energy. It also improves solubility and conductivity at room temperature. It involves activating nano gold particles with a specific wavelength light source to create surface plasmon resonance, resulting in thermoelectrons. These thermoelectrons then disrupt or reduce the hydrogen bonding capacity between water molecules in the tetrahedral chemical structure network, leading to the formation of smaller water molecules known as plasma-activated water. Studies on animals have shown that plasma-activated water possesses free radical-scavenging and antioxidant properties. It can reduce liver oxidative stress damage induced by sleep deprivation and is non-toxic. Recent studies have shown that plasma-activated water can treat cancer, chronic diseases, and degenerative conditions in animal models. In a lung cancer animal model, combining plasma-activated water with cisplatin chemotherapy increased the mice's survival time. In an animal model with chronic kidney disease, drinking plasma-activated water reduced fibronectin expression and slowed kidney fibrosis. Plasma-activated water reduced oxidative stress in an animal model of chronic sleep deprivation-induced liver damage, thereby enhancing the antioxidant and anti-inflammatory capabilities of the liver cells. In an animal model with Alzheimer's disease, it reduced amyloid-β protein expression and improved memory. In a rat model with Parkinson's disease, plasma-activated water suppressed inflammation and protected nerve cells. Since plasma-activated water has demonstrated antioxidant effects in mouse and rat animal models and previous clinical trials have shown that drinking plasma-activated water does not have toxic reactions and does not significantly affect drug metabolism in the human body, this study aims to assess the safety and potential symptom improvement effects of long-term consumption of plasma-activated water in fibromyalgia patients.
Interventions
DIETARY_SUPPLEMENTPlasma-Activated Water
Plasma-activated water is a method of storing the high-energy benefits of water and effectively utilizing its energy. It also enhances properties such as solubility and conductivity at room temperature. It involves activating nano gold particles with a specific wavelength light source to create surface plasmon resonance, resulting in thermoelectrons. These thermoelectrons then disrupt or reduce the hydrogen bonding capacity between water molecules in the tetrahedral chemical structure network, leading to the formation of smaller water molecules known as plasma-activated water.
OTHERPlacebo
Typical drinking water
Sponsors
Taipei Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Fibromyalgia Patients
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Currently experiencing widespread bodily pain for a duration of at least three months and diagnosed by a clinical specialist as a fibromyalgia patient. 2. Aged between 20 and 75 years. 3. Clear understanding and the ability to communicate with the researchers in Mandarin or Taiwanese dialect through spoken or written language. 4. Willingness to participate in this research after receiving an explanation and the ability to cooperate with the research procedures.
Exclusion criteria
1. Malignant tumors. 2. Currently experiencing an acute infection. 3. Concurrent central nervous system disorders such as stroke or Parkinson's disease. 4. Concurrent endocrine system disorders such as hypothyroidism. 5. Significant autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, lupus, and others. 6. Currently pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Blood Levels of Selected Laboratory Biomarkers | Pre-test visit, after at least 6 hours of fasting | Blood samples will be collected after participants have fasted for at least 6 hours. Samples will be analyzed for selected laboratory biomarkers, including glucose, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and/or other prespecified analytes. Glucose, total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol will be reported in mg/dL; creatinine will be reported in mg/dL; and ALT and AST will be reported in U/L. |
Countries
Taiwan
Outcome results
None listed