Overweight Nutritional and Metabolic Diseases
Conditions
Interventions
Randomized, double-blind, placebo-controlled clinical trial with 90 participants and oral administration of Spirulina (2 g/day) or placebo (cassava flour) for 60 days, in identical capsules, twice dai
(ii) overweight participants receiving Spirulina
(iii) obese participants receiving placebo
(iv) obese participants receiving Spirulina
(v) normal-weight participants receiving placebo
and (vi) normal-weight participants receiving Spirulina. Participant allocation will be performed using specialized randomization software, ensuring random and balanced allocation among the six groups
Sponsors
Universidade Federal de Ciências da Saúde de Porto Alegre
Universidade Federal de Ciências da Saúde de Porto Alegre
Eligibility
Sex/Gender
Female
Age
30 Years to 45 Years
Inclusion criteria
Inclusion criteria: Women aged between 30 and 45 years; classified as overweight with body mass index greater than or equal to 25 kg/m² and lower than 30 kg/m², class I obesity with body mass index greater than or equal to 30 kg/m² and lower than 35 kg/m², or normal weight with body mass index greater than or equal to 18.5 kg/m² and lower than 24.9 kg/m²; willing to participate in the study by signing the informed consent form; current use of oral or injectable contraceptives
Exclusion criteria
Exclusion criteria: Women with signs of infection or use of antibiotics or probiotics in the period prior to the study; use of anti-inflammatory medications during the study period; changes in medication during the study period; significant changes in dietary intake during the study period; known sensitivity or allergy to Spirulina; pregnancy or breastfeeding; previous bariatric surgery; no use of oral or injectable contraceptives; phenylketonuria; premenopausal or menopausal status
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to observe changes in pro-inflammatory cytokines (Interleukin-6 and Tumor Necrosis Factor Alpha) and anti-inflammatory cytokines (Interleukin-4 and Interleukin-10), assessed in serum samples using enzyme-linked immunosorbent assay at baseline and after 60 days of supplementation;It is expected to observe changes in thiobarbituric acid reactive substances, catalase activity, and superoxide dismutase activity, assessed in plasma and cell lysate samples using colorimetric and spectrophotometric methods at baseline and after 60 days of supplementation;It is expected to find changes in mercury concentrations, quantified in whole blood using appropriate laboratory methods such as spectrometry or inductively coupled plasma mass spectrometry at baseline and after 60 days of Spirulina supplementation | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe changes in the metabolic profile, assessed through serum measurements of total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, and fasting glucose using commercial colorimetric kits at baseline and after 60 days of supplementation;It is expected to observe changes in body composition, assessed through body weight, body mass index, body circumferences, lean mass, and body fat percentage determined by bioelectrical impedance at baseline and after 60 days of supplementation;It is expected to observe changes in dietary intake, assessed using a three-day dietary recall analyzed with WebDiet software at baseline and after 60 days of supplementation;It is expected to observe changes in cognitive and behavioral parameters, assessed using the Mini Mental State Examination, Beck Depression Inventory, and Beck Anxiety Inventory at baseline and after 60 days of supplementation;It is expected to observe associations between inflammatory markers and cognitive and behavioral assessment scores, evaluated by exploratory statistical analysis after completion of data collection | — |
Countries
BR
Contacts
Public ContactAlessandra Peres
Universidade Federal de Ciências da Saúde de Porto Alegre
Outcome results
None listed