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Combined BCAA and Omega 3 Supplementation: Clinical-Nutritional, Cardiorespiratory, Metabolic Impact and Quality of Life in Pre-Malnourished / Malnourished Patients

Combined supplementation of Ramified Chain and Omega 3 Amino Acids: clinical-nutritional, cardiorespiratory, metabolic impact and quality of life in pre-cachectic / cachectic patients - CSRCO

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-7h834x
Enrollment
Unknown
Registered
2020-01-28
Start date
2019-11-01
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

neoplasms

Interventions

The patients will be randomized into 4 groups and all will be guided by an eating plan containing an average of 30 to 35cal / kg / day, and 1.0 to 2.0g / kg / day of protein and 35% of the total energ
Dietary supplement
G07.203.300.456
G07.203.650.240

Sponsors

Universidade Federal do Maranhão
Lead Sponsor
Fundação de Amparo à Pesquisa e ao Desenvolvimento Científico e Tecnológico do Maranhão - FAPEMA
Collaborator

Eligibility

Sex/Gender
Female
Age
20 Years to 100 Years

Inclusion criteria

Inclusion criteria: Uterine Cervical Cancer; Minimum age of 20 years; Stability (no changes in treatment regimen within 6 weeks or hospitalizations within 3 months); Sign the consent form.

Exclusion criteria

Exclusion criteria: Restricted Vegetarian; Use of pacemaker; Palliative care; Withdrawal of Consent; Accession to intervention below 75%; Allergy Nutritional Composition of Supplements; Refusal of the proposed supplementation; Significant worsening after intervention.

Design outcomes

Primary

MeasureTime frame
The assessment of anthropometric data will be performed by measuring weight, height and body mass index (BMI), triceps skinfold (PCT), arm circumference (CB), arm muscle circumference (CMB) and arm muscle area (AMB). ). To evaluate the body composition will be used the electrical bioimpedance. To obtain the body weight of the patients will be used digital platform scale with coupled stadiometer (Filizola®), with a maximum capacity of 150kg and 100g graduation. The measurement will be performed according to the SISVAN technical standard (BRAZIL, 2011). The height of the patients will be evaluated with a stadiometer attached to the scale (Filizola®), accurate to 0.50cm. The procedure will be performed according to the SISVAN technical standard (BRAZIL, 2011). The BMI will be calculated from the ratio of weight (kg) to the square of height (m) and classified according to WHO (1995). For measurement of CB will be used inelastic anthropometric tape, Sanny® brand, with a maximum length of 200 cm and precision of 1 mm. The PCT will be measured with a Lange® adipometer, with a scale up to 60 mm, with a resolution of 1 mm. The CB and PCT measurement technique will follow the recommendations of Cuppari (2005). Arm muscle circumference (CMB) will be obtained by the formula [CMB = CB (cm) - (0.314 x DCT)]. For the arm muscle area the formula [CB (cm) -? x PCT (mm) ÷ 10] 2 ÷ 4? (-10 for men and -6.5 for women) (FRISANCHO, 1981). The nutritional classification of CB, PCT and CMB will be performed according to Blackburn and Thornton (1979). And the AMB according to Frisancho (1990).;To assess quality of life in cancer patients, the EORTC QLQ - C30 questionnaire of the European Organization for Research and Treatment of Cancer (EORTC) (EVANGELISTA, 2012; MONSANTO et al., 2013) will be used.

Secondary

MeasureTime frame
The 6-minute walk test (6MWT) will be performed according to the recommendations of the American Thoracic Society - ATS (CRAPO; ZEBALLOS, 2002), as well as the standardization for the Brazilian population (BRITO and SOUSA, 2006). Before and after the test, blood pressure (BP), heart rate (HR), peripheral oxygen saturation (SPO2), and the level of dyspnea and lower limb fatigue at minutes two, four and six (BORG) will be measured. 1982).;Fatigue using the Revised Piper Fatigue Scale (EFP-R), a 22-item multidimensional instrument capable of assessing a greater number of fatigue dimensions, is distributed into: behavioral, affective and sensory / psychological or sensory / cognitive / emotional (ANNEX D). The sum of EFP-R dimension points will be evaluated by averaging the respective items. The score of each question ranges from 0 to 10, with “0” being the absence of fatigue and 10 the worst possible fatigue (MOTA; PIMENTA; PIPER, 2009).;Biochemical evaluation will be performed at the beginning and end of the supplementation protocol. Lipid profile, blood count, fasting glucose, insulinemia, interleukins (IL-1 and IL-6), tumor necrosis factor -? and oxidative stress. When will blood glucose be considered high? 100mg / dl. And the lipid profile changed when: triglycerides? 150mg / dl; HDL-C 2.7 (GELONEZE et al., 2009). For the collection procedure, the patient will be instructed to be fasting for 12 hours and not to drink alcohol within 72 hours prior to the exam.;Food consumption will be estimated by the 24-hour Recall (R24H) in its own form (Appendix B), with the aid of a photo album with standardized home measurements (HC, 2012). The nutritional composition of the RD24H will be calculated using Diet Win® software.;The level of physical activity will be measured by the short version of the International Physical Activity Questionnaire (IPAQ), validated in Brazil (MATSUDO et al., 2001), according to Annex C. The classification will be performed according to Matsudo

Countries

Brazil

Contacts

Public ContactAlexsandro dos Santos

Universidade Federal do Maranhão

fs_alexsandro@yahoo.com.br+55(98)32728538

Outcome results

None listed

Source: REBEC (via WHO ICTRP)