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Effect of FortiFit PRO® supplement associated with resistance exercise and diet in muscle function of independent elderly with loss of muscle mass

Effect of FortiFit PRO® supplement associated with resistance exercise and diet in muscle function of independent elderly with Sarcopenia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9jk2yh
Enrollment
Unknown
Registered
2020-02-05
Start date
2020-02-03
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

Sarcopenia

Interventions

Experimental group: 5 Independent elderly people to perform activities of daily living, who will receive guidance to follow a diet with 30kcal / kg / day containing 1.2g of high quality protein / kg /
Dietary supplement
G07.203.300.456

Sponsors

Ibramep - Instituto Brasileiro de Medicina e PEsquisa
Lead Sponsor
Ibramep - Instituto Brasileiro de Medicina e PEsquisa
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Age over 65 years; Gender: female and male 3) Sarcopenia according to the diagnostic criteria of EWGSOP2: Sarc-F questionnaire: score greater than or equal to 6; Handgrip test (grip strength): men under 27kg, women under 16kg or Stand up / sit test: more than 15 seconds for 5 climbs; skeletal musAgecle mass: men less than 20kg, women less than 15kg or skeletal muscle mass / height2: men less than 7.0 kg / m2; women less than 5.5 kg / m2 - SPPB tests: score greater than 8; Sedentary lifestyle; Independent in relation to activities of daily living (score greater than or equal to 46 on the modified Barthel index) Rely on support persons (family members or external staff) to assist in following the diet and study recommendations; Having provided written consent to participate in the study, confirmed by signing the Informed Consent Form.

Exclusion criteria

Exclusion criteria: Creatinine clearance less than 35 mL / min; Use of nasogastric tube or gastrostomy; Bedridden patients; Parkinson's disease; Type 1 diabetes, chronic kidney disease; Severe heart diseases; Other clinical conditions that may, according to medical criteria, make physical exercise and / or food supplementation unfeasible with FortiFit PRO®; Vitamin D level less than 20ng / ml at the end of the run-in period; BMI greater than or equal 30

Design outcomes

Primary

MeasureTime frame
Increased strength in independent elderly diagnosed with sarcopenia after 12 weeks of intervention with FortiFit PRO® supplement associated with physical exercise.

Secondary

MeasureTime frame
After 12 weeks of intervention with FortiFit PRO® supplement associated with physical exercise: Improvement of muscle mass assessed through DXA; ;After 12 weeks of intervention with FortiFit PRO® supplement associated with physical exercise: Improvement of physical performance through SPPB;;After 12 weeks of intervention with FortiFit PRO® supplement associated with physical exercise:Improvement in the level of physical activity;;After 12 weeks of intervention with FortiFit PRO® supplement associated with physical exercise: Improvement in the quality of life.

Countries

Brazil

Contacts

Public ContactElaine Maretti

Ibramep - Instituto Brasileiro de Medicina e PEsquisa

elaine@ubramep.cpm.br+5520216869

Outcome results

None listed

Source: REBEC (via WHO ICTRP)