Protein Supplementation in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction and Exercise

NCT04981366 | Completed Results

• 1 other identifier: 04234918.1.0000.0065
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate if protein supplementation increases the benefits of exercise training in the elderly with sarcopenic obesity undergoing caloric restriction.

Conditions

Sarcopenic Obesity; Aging

Outcome Measures

Primary Outcomes (4)

• Percentage of Fat-free Mass

  Fat-free mass evaluated through dual-energy x-ray absorptiometry (DEXA) and reported as percentage

  Baseline (Pre-intervention) and 16 weeks (Post-intervention)

• Appendicular Fat-free Mass

  Appendicular fat-free mass was evaluated through dual-energy x-ray absorptiometry (DEXA) and calculated as the sum of the fat-free mass of the upper and lower limbs.

  Baseline (Pre-intervention) and 16 weeks (Post-intervention)

• Appendicular Fat-free Mass to Body Mass Index Ratio

  The appendicular fat-free mass (AFFM) was assessed using dual-energy X-ray absorptiometry (DXA) and expressed in kilograms (kg). The body mass index (BMI) was calculated as weight in kilograms divided by the square of height in meters (kg/m²). The AFFM/BMI ratio was computed by dividing AFFM (kg) by BMI (kg/m²), resulting in a unitless ratio. Higher values indicate greater muscle mass relative to body size

  Baseline (Pre-intervention) and 16 weeks (Post-intervention)

• Leg Fat-free Mass

  Appendicular fat-free mass was evaluated through dual-energy x-ray absorptiometry (DEXA) and calculated as the sum of the fat-free mass of the lower limbs.

  Baseline (Pre-intervention) and 16 weeks (Post-intervention)

Secondary Outcomes (34)

• Fat-mass

  Baseline (Pre-intervention) and 16 weeks (Post-intervention)

• Quadriceps Cross-sectional Area (CSA)

  Baseline (Pre-intervention) and 16 weeks (Post-intervention)

• Rectus Femoris Cross-sectional Area (CSA)

  Baseline (Pre-intervention) and 16 weeks (Post-intervention)

• Vastus Lateralis Cross-sectional Area (CSA)

  Baseline (Pre-intervention) and 16 weeks (Post-intervention)

• Muscle Fiber Cross-sectional Area (fCSA)- Type I

  Baseline (Pre-intervention) and 16 weeks (Post-intervention)

Other Outcomes (23)

• Lipid Profile (HDL)

  Baseline (Pre-intervention) and 16 weeks (Post-intervention)

• Lipid Profile (LDL)

  Baseline (Pre-intervention) and 16 weeks (Post-intervention)

• Lipid Profile (VLDL)

  Baseline (Pre-intervention) and 16 weeks (Post-intervention)

Study Arms (3)

Control group (CTRL)

NO INTERVENTION

Patients allocated to this arm will not receive any intervention.

Caloric Restriction associated to exercise training plus protein supplementation (CREX+PTN)

EXPERIMENTAL

Patients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus protein supplementation.

Dietary Supplement: Protein supplement

Caloric Restriction associated to exercise training plus isocaloric placebo (CREX+PLA)

PLACEBO COMPARATOR

Patients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus isocaloric placebo.

Dietary Supplement: isocaloric supplement

Interventions

Protein supplement DIETARY_SUPPLEMENT

40g of whey protein in the breakfast;

Caloric Restriction associated to exercise training plus protein supplementation (CREX+PTN)

isocaloric supplement DIETARY_SUPPLEMENT

42g of isocaloric supplement in the breakfast;

Caloric Restriction associated to exercise training plus isocaloric placebo (CREX+PLA)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years and older;
• Body mass index (BMI) \> 30 kg/m2;
• Sarcopenia;
• not engage into exercise training programas.

You may not qualify if:

• cancer in the last 5 years;
• cognitive deficit or dementia that impossibility the patient to read and sign the informed consent form;
• any disease that limits participation in exercise training program.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo

São Paulo, 05508-030, Brazil

Location

Results Point of Contact

• Title: Prof. Hamilton Roschel
• Organization: University of São Paulo

hars@usp.br

+55 11 30618789

Study Officials

• Hamilton Roschel, Phd

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 29, 2021
• Study Start: August 1, 2021
• Primary Completion: August 21, 2023
• Study Completion: August 25, 2023
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)