Effects of supplementation of some nutrients, in elderly, on the inflammation, the muscle, the bone and the body fat

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-6qr9xx
• Date of registration: 10/10/2016
• Prospective Registration: No
• Primary sponsor: Escola de Artes, Ciências e Humanidades da Universidade de São Paulo
• Public title: Effects of supplementation of some nutrients, in elderly, on the inflammation, the muscle, the bone and the body fat
• Scientific title: Effects of nutritional supplementation on intestine permeability, systemic inflammation and body composition consequences in elderly
• Date of first enrolment: 01/06/2013
• Recruitment status: Data analysis completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-6qr9xx
• Study type: Intervention
• Study design: Randomized and controlled preventive clinical trial, paralell, double blind with three arms.
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Sandra Maria Lima Ribeiro
• Affiliation: Faculdade de Saúde Pública da Universidade de São Paulo

• Name: Sandra Maria Lima Ribeiro
• Affiliation: Faculdade de Saúde Pública da Universidade de São Paulo

Key inclusion & exclusion 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: 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.

Age minimum: 60Y
Age maximum: 90Y
Gender: -

Health Condition(s) or Problem(s) studied

Systemic inflammation Sarcopenia

C23.550.470

C10.597.613.612.500

Intervention(s)

D12.125.068.330

J02.500.456.716

Dietary supplement

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 night. These two doses are received by them in non-identified opaque envelops; 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 rhamnosus 109 a 108 UFC, Lactobacillus acidophilus 109 a 108 UFC e Bifidobacterium lactis 109 a 108 UFC/day. Group GLU- amino acid glutamine, de 6g/day. The Control Group (Group PLA), have 6g of maltodextrin/day.

Primary Outcome(s)

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 Outcome(s)

Secondary outcomes were not investigated

Source(s) of Monetary Support

Invictus Farmanutrição

Fundação de Amparo à Pesquisa da Universidade de São Paulo- FAPESP

Secondary Sponsor(s)

Centro de Saúde Escola Geraldo Horácio de Paula Souza