Low Calorie Diet or VLCKD Combined With Physical Training for Preserving Muscle Mass During Weight Loss in Sarcopenic Obesity

Study Overview
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Brief Summary
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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.

Official Title
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Low Calorie Diet or Very Low Calorie Ketogenic Diet Combined With Physical Training for Preserving Muscle Mass During Weight Loss in Sarcopenic Obesity

Conditions
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Sarcopenic Obesity

Intervention / Treatment
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* Dietary Supplement: meal replacements or supplementation with leucine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VLCKD group<br>patients followed a structured VLCKD protocol (800Kcal/die) | Dietary Supplement: meal replacements or supplementation with leucine<br>* meal replacements or animal protein or supplementation with leucine<br>|
| Active Comparator: VLCKD and Physical Training group<br>patients followed a structured VLCKD protocol (800Kcal/die) combined with interval training (IT), two times a week | Dietary Supplement: meal replacements or supplementation with leucine<br>* meal replacements or animal protein or supplementation with leucine<br>|
| Active Comparator: LCD and Leucine supplementation group<br>patients followed a LCD regimen (1000 kcal/day) with supplementation of 18 g whey proteins which 4.1 g of leucine | Dietary Supplement: meal replacements or supplementation with leucine<br>* meal replacements or animal protein or supplementation with leucine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Body weight change from baseline | Body weight will be calculated at baseline and after 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index | Body Mass Index change from baseline | Body Mass Index will be calculated at baseline and after 45 days | 
| Fat Mass | Fat mass percentage (%) change from baseline | Fat Mass will be calculated at baseline and after 45 days | 
| Fat Free Mass | Fat Free mass percentage (%) change from baseline | Fat Free mass will be calculated at baseline and after 45 days | 
| Fasting glucose | Fasting glucose level (mg/dL) change from baseline | Fasting glucose will be calculated at baseline and after 45 days | 
| Fasting insulin | Fasting Insulin level (mcU/mL) change from baseline | Fasting insulin will be calculated at baseline and after 45 days | 
| Muscle strength | Muscle strength (kg) change from baseline | Muscle strength will be calculated at baseline and after 45 days | 
| Physical Performance assessed by Short Physical Performance Battery (SPPB) | Physical Performance change from baseline | SPPB will be calculated at baseline and after 45 days |