Sarcopenic Obesity
Conditions
Brief summary
The prevalence of sarcopenic obesity (SO) is increasing worldwide, posing important challenges to public health and national health care system, especially during the COVID pandemic. In subjects with SO, it is essential to reduce body weight preserving lean mass, in order to avoid a worsening of muscle function. Lifestyle modification with adequate nutrition and proper physical activity is essential to counteract SO progression. In accordance with the Position Statement of the Italian Society of Endocrinology, Very Low Calorie Ketogenic Diet (VLCKD), a well established nutritional intervention in the context of obesity, has been promoted also for the treatment of SO. Moreover, the source of protein, timing of intake, and specific amino-acid constitution also represent critical factors in increasing muscle mass and strength. Recent studies have shown how protein supplementation, especially with high leucine content, can be effective in degenerative and end-stage diseases. To date, the effects of physical training during VLCKD have not been studied. The aim is to determine the efficacy of VLCKD combined with interval training, compared to a VLCKD or a LCD alone, on weight-loss, body composition and physical performance in patient with SO.
Interventions
DIETARY_SUPPLEMENTmeal replacements or supplementation with leucine
meal replacements or animal protein or supplementation with leucine
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* obesity (BMI 30-40) * FAT MASS % ( \> 41% for W, \>29% for M) * HOMA-IR \> 2,5
Exclusion criteria
* known hypersensitivity to one or more components used in the protocol products; history of renal, cardiac or cerebrovascular diseases; psychiatric disturbances; hydroelectrolytic alterations, diagnosis of type 1 diabetes lack of informed consent; history of or planned weight loss surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | Body weight will be calculated at baseline and after 45 days | Body weight change from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | Body Mass Index will be calculated at baseline and after 45 days | Body Mass Index change from baseline |
| Fat Mass | Fat Mass will be calculated at baseline and after 45 days | Fat mass percentage (%) change from baseline |
| Fat Free Mass | Fat Free mass will be calculated at baseline and after 45 days | Fat Free mass percentage (%) change from baseline |
| Fasting glucose | Fasting glucose will be calculated at baseline and after 45 days | Fasting glucose level (mg/dL) change from baseline |
| Muscle strength | Muscle strength will be calculated at baseline and after 45 days | Muscle strength (kg) change from baseline |
| Physical Performance assessed by Short Physical Performance Battery (SPPB) | SPPB will be calculated at baseline and after 45 days | Physical Performance change from baseline |
| Fasting insulin | Fasting insulin will be calculated at baseline and after 45 days | Fasting Insulin level (mcU/mL) change from baseline |
Countries
Italy
Outcome results
None listed