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Effect of using Supplements with Immunomodulatory Nutrients in the preoperative period of Major Surgeries

Effectiveness of using an Immunomodulatory Formula in the preoperative period of Major Surgeries

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10b2vr39
Enrollment
Unknown
Registered
2025-02-05
Start date
2023-01-05
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Neoplasms

Interventions

This is a non-randomized clinical study, consisting of a convenience sample. Experimental group: 40 individuals, men and women, adults and elderly, in outpatient follow-up, candidates for major electi

Sponsors

Faculdade de Nutrição Emília de Jesus Ferreiro
Lead Sponsor
Faculdade de Nutrição Emília de Jesus Ferreiro
Collaborator

Eligibility

Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: Individuals aged between 20 and 80 years; of both sexes; candidates for major elective surgeries followed on an outpatient basis at the Antônio Pedro University Hospital of the Fluminense Federal University (HUAP/UFF)

Exclusion criteria

Exclusion criteria: Participants will be excluded if they: cannot use the gastrointestinal tract as a feeding route during the study period; have amputated limbs; have previously consumed source foods or dietary supplements containing arginine, omega 3 and/or nucleotides on a regular basis, and/or in a dose and time different from that estimated by this study; have a history of allergy to cow's milk protein, fish and soy or lactose intolerance; have previously used probiotics, symbiotics or antibiotics during the last 2 months prior to the perioperative period; are in a condition of pregnancy or lactation; have severe organic dysfunctions (carriers of cardiovascular diseases, chronic kidney disease and neurodegenerative diseases); have received postoperative immunomodulatory enteral supplementation in a dose and time different from that stipulated in this study

Design outcomes

Primary

MeasureTime frame
Improvement in the intestinal microbiota profile is expected in patients who used immunomodulatory supplementation in the preoperative period. Data collected 1 to 2 days before supplementation and immediately after supplementation for 5 days. An increase of >10% in species of the Firmicutes phylum is expected.;More effective preservation of body composition and muscle strength measured by bioelectrical impedance and dynamometry, respectively, is expected in patients who used immunomodulatory supplementation in the preoperative period. Data were collected 7 to 20 days before the intervention and 30 and 120 days after the intervention. A loss of total muscle mass and strength of <5% compared to the preoperative period is expected.

Secondary

MeasureTime frame
A reduction in postoperative hospital stay is expected in patients who used immunomodulatory supplementation in the preoperative period. Data collected within 30 days of the date of hospitalization. A reduction of more than 2 days is expected.

Countries

Brazil

Contacts

Public ContactManuela Nascimento

Universidade Federal Fluminense

mabreu@id.uff.br+55 (21) 997297560

Outcome results

None listed

Source: REBEC (via WHO ICTRP)