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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VLCKD group | Experimental | patients followed a structured VLCKD protocol (800Kcal/die) |
|
| VLCKD and Physical Training group | Active Comparator | patients followed a structured VLCKD protocol (800Kcal/die) combined with interval training (IT), two times a week |
|
| LCD and Leucine supplementation group | Active Comparator | patients followed a LCD regimen (1000 kcal/day) with supplementation of 18 g whey proteins which 4.1 g of leucine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| meal replacements or supplementation with leucine | Dietary Supplement | meal replacements or animal protein or supplementation with leucine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Body weight change from baseline | Body weight will be calculated at baseline and after 45 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapienza University of Rome | Roma | RM | 00161 | Italy |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D007930 | Leucine |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| 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 |
| D000597 |
| Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |