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

Aging Clinical Trial

Official title:

Effects of the Protein Supplementation Associated With Exercise Training in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04981366
• Other study ID #: 04234918.1.0000.0065
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: August 25, 2023

Study information

• Verified date: May 2024
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 25, 2023
• Est. primary completion date: August 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Obesity
• Sarcopenic Obesity

Intervention

Dietary Supplement:
• Protein supplement
40g of whey protein in the breakfast;
• isocaloric supplement
42g of isocaloric supplement in the breakfast;

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lipid profile	Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) will be evaluated by colorimetric enzymatic methods	16 weeks
Other	Inflammatory profile	Inflammatory profile (i.e.; IL1ß, IL-10, IL-6, IL-4, TNF-a and C-Reactive Protein) will be quantified using the Luminex xMAP technology	16 weeks
Other	Bone turnover	Bone turnover (i.e.; CTX, P1NP, DKK1, sclerostin, osteocalcin, and osteopontin) will be quantified using the - Luminex xMAP technology;	16 weeks
Other	Brachial flow-mediated dilation (FMD)	Brachial flow-mediated dilation (FMD) will be assessed by High-resolution B-mode ultrasound	16 weeks
Other	Cardiometabolic Risk Score	Cardiometabolic Risk Score will be assessed by clustered cardiometabolic risk index	16 weeks
Other	Quadriceps cross-sectional area (CSA)	Quadriceps cross-sectional area (CSA) will be assessed by computed tomography imaging	16 weeks
Other	Muscle fiber cross-sectional area (fCSA)	Muscle fiber cross-sectional area (fCSA) will be assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy	16 weeks
Other	Satellite cell content (SC) and myonuclei content	Satellite cell content (SC) and myonuclei content will be assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy	16 weeks
Other	Muscle fibre capillarization	Muscle fibre capillarization will be assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy	16 weeks
Other	Oxidative stress	Oxidative stress (i.e,; SOD, CAT, glutathione, GPx, GSH and MDA) will be determined through ELISA assay.	16 weeks
Other	Gut hormones	Gut hormones (i.e.; Ghrelin, GIP, GLP-1, PP, PYY) will be quantified using the Luminex xMAP technology	16 weeks
Other	Telomere length	Telomere length will be assessed by quantitative real-time PCR	16 weeks
Other	Anxiety	Anxiety will be assessed by the Geriatric Anxiety Inventory (GAI)	16 weeks
Other	Depression	Depression will be assessed by the Geriatric Depression Scale (GDS)	16 weeks
Other	Ccognitive processing speed	Cognitive processing speed will be assessed by Trail Making Test (TMT).	16 weeks
Other	Cognitive executive function	Cognitive executive function will be assessed by Stroop Test (Victoria version)	16 weeks
Other	Sleep Quality	Sleep Quality will be assessed by Pittsburgh Sleep Quality Index(TMT).	16 weeks
Other	Health-related quality of life	Health-related quality of life will be evaluated by 36-Item Short Form Health Survey questionnaire (SF-36)	16 weeks
Primary	Fat-free mass	Fat-free mass evaluated trough dual-energy x-ray absorptiometry (DEXA)	16 weeks
Secondary	Fat-mass	Fat mass evaluated trough dual-energy x-ray absorptiometry (DEXA)	16 weeks
Secondary	bone mineral density	bone mineral density evaluated trough dual-energy x-ray absorptiometry (DEXA)	16 weeks
Secondary	Bone microarchitecture	Bone microarchitecture will be assessed using a high resolution peripheral quantitative computed tomography (HR-pQCT)	16 weeks
Secondary	Muscle function	Muscle function evaluated trough battery of tests	16 weeks
Secondary	Muscle strength	Muscle strength will be evaluated using maximal dynamic strength test [1RM])	16 weeks
Secondary	Cardiorespiratory fitness	Cardiorespiratory fitness will be evaluated by maximal oxygen uptake (VO²max) during a maximal exercise test on a treadmill	16 weeks
Secondary	Insulin sensitivity as assessed by surrogates of insulin sensitivity	Oral glucose tolerance test	16 weeks