Effect of fermented blueberry-alfalfa drink on tolerability and blood parameters of healthy volunteers Not Applicable
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Aged 18 years and over 3. Willingness to maintain a stable diet and physical activity level 4. Willingness to cease using probiotic products and supplements (except vitamin D) during the study period 5. Normal or not clinically relevant deviations in safety laboratory values
Exclusion criteria
Exclusion criteria: 1. Acute or chronic inflammatory disease 2. Gastrointestinal diseases (e.g. Crohn's disease, inflammatory bowel disease, ulcerative colitis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events measured using a patient diary (follow chart), a self-administered follow-up questionnaire filled out once per day for 21 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety parameters (e.g. white blood [WBC] and red blood [RBC] indices, inflammation [CRP], kidney and liver parameters) measured by standard laboratory methods in the United Laboratories of the Tartu University Hospital at baseline and the end of the study 2. Experimental parameters (e.g. adiponectin and leptin) measured from the blood samples using ELISA commercial kits (R&D Systems) and blood samples taken at baseline and the end of the study | — |
Countries
Estonia