Systemic inflammation Sarcopenia
Conditions
Interventions
The experiment, lasting six months, is composed by three experimental groups, with 25 elderlies each. They receive different nutritional supplements, and the intake is made at two moments, morning and
these envelops were organized by the industry. The constituted groups are: Group SIM- synbiotic substance, composed by Fructooligosaccharide 6 g, Lactobacillus paracasei 109 a 108 UFC, Lactobacillus r
Dietary supplement
J02.500.456.716
Sponsors
Escola de Artes, Ciências e Humanidades da Universidade de São Paulo
Centro de Saúde Escola Geraldo Horácio de Paula Souza
Eligibility
Age
60 Years to 90 Years
Inclusion criteria
Inclusion criteria: Elderly above 60 and below 90 years old; both genders; independent and non-institutionalized; they have to fill at least one of the following criteria of frailty: non-intentional body weight loss in the last six months; exhaustion evaluated by a geriatric depression scale; grip strength below the expected values; gait speed below the expected values; reduced energy expenditure.
Exclusion criteria
Exclusion criteria: Presence of acute or chronic intestinal inflammatory disease; current use of antibiotics; current use of supplements of protein, hormones or other substances driven to enhance muscle mass; current use of synbiotic, probiotic or prebiotic substances; having caner or any inflammatory disease in the last six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of Systemic inflammation, evaluated by the ratio between inflammatory cytokines interleucin-10 (IL-10) and interleucin-6 (IL-6), verified from a variation of at least 5% in plasma levels, comparing pre and post experiment values. ;The expected outcome (IL-10/IL-6 ratio) was not found in this clinical trial, because the mean comparision between groups did not show statistical significance. In more details, we analyzed the outcome using repeated measures ANOVA. The IL-10/IL-6 ratio (both measures in ng/dL) the observed values in group SIM (supplemented with synbiotics) were 2,3±0,3 (initial values) and 2,8±0,6 (final values). The placebo group (PLA), the values were 4.0±0.8 (initial values) and 2,4±0,3 (final values). The p-value, taking into account the groups, was 0.17; taking into account the time, the p-value was 0.68; the interaction time x group resulted in a p-value of 0.19. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes were not investigated | — |
Countries
Brazil
Contacts
Public ContactSandra Lima Ribeiro
Faculdade de Saúde Pública da Universidade de São Paulo
Outcome results
None listed