Healthy Volunteers
Conditions
Interventions
Group I (Experimental): Fucoidan 125 mg/capsule every 12 hours (orally) for 3 months
Group II (Experimental): Fucoidan 500 mg/capsule every 12 hours (orally) for 3 months
Group III (Control): Placebo
Sponsors
Hermanos Ameijeiras Clinical Surgical Hospital
Eligibility
Sex/Gender
All
Age
19 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Healthy Individuals 19-65 years of age without distinction of sex or skin color who give their consent to participate in the study. 2. Not consuming probiotic formulations at the time of recruitment for the study 3. Not taking anti-inflammatory drugs
Exclusion criteria
Exclusion criteria: 1. Individuals with allergies to fish and/or shellfish. 2. Individuals who suffer from the dysbiosis studied and who are ingesting some type of probiotic formulation at the time of starting the study. 3. Individuals for whom seaweed is part of normal diet. 4. Individuals who do not consent to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal Microbiome Taxonomic Profile and Predicted Functional Potential of the Microbiome (It will use the bioinformatic program PICRUSt as follows: a. Inflammation Index, b. Alpha Diversity, c. Beta Diversity, d. Compositional Analysis, e. LEfSe (Linear discriminant analysis Effect Size), i. Taxonomic, ii. Functional). Measurement time: At baseline (day 0), 1 month and, 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1- Quality of life (SF-36 International Health Survey, which evaluates various aspects of the quality of life related to an individual's mental health). Measurement time: At baseline (Day 0), 1 month and 3 months 2- Adverse Events- AE (Presence of the AE (It doesn't seem to have any AE, Possible AE, Similar to AE, AE); Intensity of the AE (It doesn't seem to have any AE, Mild (Does not produce restrictions in daily activities), Moderate (Produces partial restriction of daily activities), Severe (inability to perform daily activities))). Measurement time: 3 months 3- Hematological variables and clinical chemistry (Laboratory values will be determined using the Cobas 6000 automatic immunochemical analyzer from the Roche Diagnóstica company. It will be determined Liver enzymes, Creatinine and Urea; Hematological parameters (Blood glucose, Leukocytes, Erythrocytes, Hemoglobin, Hematocrit, MCV, MCHC, RDW, Platelets, MPV, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils)). Measurement time: At baseline (Day 0), 1 month and 3 months 4- Inflammatory variables (C-reactive protein (normal values less than 10 mg/L), Calprotectin in feces (Values in ug/g. Normal values less than 50ug/g. A value between 50-200ug/g indicates mild intestinal inflammation)). Measurement time: At baseline (Day 0), 1 month and 3 months 5- Intestinal Transit | — |
Countries
Cuba
Contacts
Public ContactGissel Garcia Menendez
Hermanos Ameijeiras Clinical Surgical Hospital
Outcome results
None listed