Tool for Fibromyalgia Diagnosis and Effect of Extra Virgin Olive Oil (FIBROKIT)
Fibromyalgia
About this trial
This is an interventional diagnostic trial for Fibromyalgia focused on measuring Fibromyalgia, Olive oil, Nutrition, Mediterranean diet, Proteomics, Metagenomics, Microbiome
Eligibility Criteria
Inclusion Criteria: Women between 40 and 59 years Do not carry out any type of guided and structured physical activity (detailed in the exclusion criteria) Follow a balanced diet in terms of the food source (fruits, vegetables, legumes, meat, fish, etc.). Exclusion Criteria: Being outside the established age range (40-59) at the time of the start of the study Have practiced some type of structured or planned physical activity more than 2 times a week during the last month, such as: Go to collective classes of Yoga, Tai-Chi, Zumba, dance, gymnastics or similar Going for a walk, cycling, hiking or similar for 30 minutes or more than 10,000 steps per day Being underweight (BMI < 18.5) or type II or higher obesity (BMI > 34.9) Suffer and have been diagnosed with any of the following chronic pathologies: any type of cancer Acquired Immunodeficiency Syndrome (AIDS) Inflammatory diseases (rheumatoid arthritis, osteoarthritis) Gastrointestinal diseases (Crohn's disease, ulcerative colitis) Cardiovascular diseases (atherosclerosis, cardiomyopathy, stroke) Autoimmune diseases (systemic lupus erythematosus, celiac disease, Hashimoto's thyroiditis, multiple sclerosis) Metabolic diseases (Type I and II Diabetes, Metabolic Syndrome) Having been under intensive pharmacological treatment (3 or more drugs daily) with non-steroidal anti-inflammatory drugs, corticosteroids, analgesics, or antidepressants during the month prior to the start of the study. Being under antioxidant supplementation (Glutathione, Coenzyme Q10, plant extracts, phenolic compounds) Consuming an amount greater than 12 g/day of alcohol, admitted in the context of the Mediterranean diet (Willett et al., 1995). Smoking or consuming any type of narcotic substance (regardless of the amount and frequency)
Sites / Locations
- Pronacera Therapeutics Laboratory
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
MED DIET + AOVE
MED DIET + AO
A six-months nutritional intervention with a Mediterranean diet, daily supplemented with 50 ml of extra virgin olive oil. The intake of the oil was divided in the main meals and needed to be consumed without cooking.
A six-months nutritional intervention with a Mediterranean diet, daily supplemented with 50 ml of olive oil. The intake of the oil was divided in the main meals and needed to be consumed without cooking.