Protein Supplementation in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction and Exercise
Primary Purpose
Sarcopenic Obesity, Aging
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Protein supplement
isocaloric supplement
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenic Obesity
Eligibility Criteria
Inclusion Criteria:
- 65 years and older;
- Body mass index (BMI) > 30 kg/m2;
- Sarcopenia;
- not engage into exercise training programas.
Exclusion Criteria:
- 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.
Sites / Locations
- University of Sao PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Placebo Comparator
Arm Label
Control group (CTRL)
Caloric Restriction associated to exercise training plus protein supplementation (CREX+PTN)
Caloric Restriction associated to exercise training plus isocaloric placebo (CREX+PLA)
Arm Description
Patients allocated to this arm will not receive any intervention.
Patients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus protein supplementation.
Patients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus isocaloric placebo.
Outcomes
Primary Outcome Measures
Fat-free mass
Fat-free mass evaluated trough dual-energy x-ray absorptiometry (DEXA)
Secondary Outcome Measures
Fat-mass
Fat mass evaluated trough dual-energy x-ray absorptiometry (DEXA)
bone mineral density
bone mineral density evaluated trough dual-energy x-ray absorptiometry (DEXA)
Bone microarchitecture
Bone microarchitecture will be assessed using a high resolution peripheral quantitative computed tomography (HR-pQCT)
Muscle function
Muscle function evaluated trough battery of tests
Muscle strength
Muscle strength will be evaluated using maximal dynamic strength test [1RM])
Cardiorespiratory fitness
Cardiorespiratory fitness will be evaluated by maximal oxygen uptake (VO²max) during a maximal exercise test on a treadmill
Insulin sensitivity as assessed by surrogates of insulin sensitivity
Oral glucose tolerance test
Full Information
NCT ID
NCT04981366
First Posted
July 1, 2021
Last Updated
November 1, 2022
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04981366
Brief Title
Protein Supplementation in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction and Exercise
Official Title
Effects of the Protein Supplementation Associated With Exercise Training in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
A major subset of adults over the age of 65 is now classified as having sarcopenic obesity, a high-risk geriatric syndrome predominantly observed in an aging population that is at risk of synergistic complications from both sarcopenia and obesity.
Lifestyle interventions such as caloric restriction and exercise training are effective nonpharmacological strategies to mitigate some adverse effects related to this condition. Also, protein supplementation may boost the benefits of exercise, but this assumption is still to be tested. This trial aims to test whether protein supplementation is able to increase the benefits of exercise training in the elderly with sarcopenic obesity undergoing caloric restriction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenic Obesity, Aging
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group (CTRL)
Arm Type
No Intervention
Arm Description
Patients allocated to this arm will not receive any intervention.
Arm Title
Caloric Restriction associated to exercise training plus protein supplementation (CREX+PTN)
Arm Type
Experimental
Arm Description
Patients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus protein supplementation.
Arm Title
Caloric Restriction associated to exercise training plus isocaloric placebo (CREX+PLA)
Arm Type
Placebo Comparator
Arm Description
Patients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus isocaloric placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein supplement
Intervention Description
40g of whey protein in the breakfast;
Intervention Type
Dietary Supplement
Intervention Name(s)
isocaloric supplement
Intervention Description
42g of isocaloric supplement in the breakfast;
Primary Outcome Measure Information:
Title
Fat-free mass
Description
Fat-free mass evaluated trough dual-energy x-ray absorptiometry (DEXA)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Fat-mass
Description
Fat mass evaluated trough dual-energy x-ray absorptiometry (DEXA)
Time Frame
16 weeks
Title
bone mineral density
Description
bone mineral density evaluated trough dual-energy x-ray absorptiometry (DEXA)
Time Frame
16 weeks
Title
Bone microarchitecture
Description
Bone microarchitecture will be assessed using a high resolution peripheral quantitative computed tomography (HR-pQCT)
Time Frame
16 weeks
Title
Muscle function
Description
Muscle function evaluated trough battery of tests
Time Frame
16 weeks
Title
Muscle strength
Description
Muscle strength will be evaluated using maximal dynamic strength test [1RM])
Time Frame
16 weeks
Title
Cardiorespiratory fitness
Description
Cardiorespiratory fitness will be evaluated by maximal oxygen uptake (VO²max) during a maximal exercise test on a treadmill
Time Frame
16 weeks
Title
Insulin sensitivity as assessed by surrogates of insulin sensitivity
Description
Oral glucose tolerance test
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Lipid profile
Description
Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) will be evaluated by colorimetric enzymatic methods
Time Frame
16 weeks
Title
Inflammatory profile
Description
Inflammatory profile (i.e.; IL1β, IL-10, IL-6, IL-4, TNF-α and C-Reactive Protein) will be quantified using the Luminex xMAP technology
Time Frame
16 weeks
Title
Bone turnover
Description
Bone turnover (i.e.; CTX, P1NP, DKK1, sclerostin, osteocalcin, and osteopontin) will be quantified using the - Luminex xMAP technology;
Time Frame
16 weeks
Title
Brachial flow-mediated dilation (FMD)
Description
Brachial flow-mediated dilation (FMD) will be assessed by High-resolution B-mode ultrasound
Time Frame
16 weeks
Title
Cardiometabolic Risk Score
Description
Cardiometabolic Risk Score will be assessed by clustered cardiometabolic risk index
Time Frame
16 weeks
Title
Quadriceps cross-sectional area (CSA)
Description
Quadriceps cross-sectional area (CSA) will be assessed by computed tomography imaging
Time Frame
16 weeks
Title
Muscle fiber cross-sectional area (fCSA)
Description
Muscle fiber cross-sectional area (fCSA) will be assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy
Time Frame
16 weeks
Title
Satellite cell content (SC) and myonuclei content
Description
Satellite cell content (SC) and myonuclei content will be assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy
Time Frame
16 weeks
Title
Muscle fibre capillarization
Description
Muscle fibre capillarization will be assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy
Time Frame
16 weeks
Title
Oxidative stress
Description
Oxidative stress (i.e,; SOD, CAT, glutathione, GPx, GSH and MDA) will be determined through ELISA assay.
Time Frame
16 weeks
Title
Gut hormones
Description
Gut hormones (i.e.; Ghrelin, GIP, GLP-1, PP, PYY) will be quantified using the Luminex xMAP technology
Time Frame
16 weeks
Title
Telomere length
Description
Telomere length will be assessed by quantitative real-time PCR
Time Frame
16 weeks
Title
Anxiety
Description
Anxiety will be assessed by the Geriatric Anxiety Inventory (GAI)
Time Frame
16 weeks
Title
Depression
Description
Depression will be assessed by the Geriatric Depression Scale (GDS)
Time Frame
16 weeks
Title
Ccognitive processing speed
Description
Cognitive processing speed will be assessed by Trail Making Test (TMT).
Time Frame
16 weeks
Title
Cognitive executive function
Description
Cognitive executive function will be assessed by Stroop Test (Victoria version)
Time Frame
16 weeks
Title
Sleep Quality
Description
Sleep Quality will be assessed by Pittsburgh Sleep Quality Index(TMT).
Time Frame
16 weeks
Title
Health-related quality of life
Description
Health-related quality of life will be evaluated by 36-Item Short Form Health Survey questionnaire (SF-36)
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
65 years and older;
Body mass index (BMI) > 30 kg/m2;
Sarcopenia;
not engage into exercise training programas.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamilton Roschel, Phd
Phone
+551130618789
Email
hars@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamilton Roschel, Phd
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo
City
São Paulo
ZIP/Postal Code
05508-030
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamilton Roschel, PhD
Phone
+55 11 3061-8789
Email
hars@usp.br
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Protein Supplementation in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction and Exercise
We'll reach out to this number within 24 hrs