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The effectiveness of low-protein diets supplemented with essential aminoacid (EAA) formulas in genetic disorders of amino acid (AA) catabolism, such as maple syrup urine disease (MSUD), is widely recognized (Blackburn PR et al. 2017). The main aim of the present study is to evaluate a difference in the effectiveness of a multidisciplinary rehabilitation program in patients with high degree of obesity with and without supplementation of this new formula of amino acids (essential + tricarboxylic acids - EAA-AC). For this reason, patients of both sexes, aged between 45 and 65, suffering from high-grade obesity will be recruited in Piancavallo. The enrolled patients divided, randomly, into two groups will be given: EAA-AC group a low-calorie and low-protein diet integrated with 4 sachets of EAA-AC supplement per day; the control group will follow a low-calorie and low-protein diet only with placebo. The parameters considered, after two weeks of treatment, will be: weight loss; the maintenance/recovery of muscle mass assessed through changes in body composition and functional tests (Hand grip, 6MWT or TUG) but also through the analysis of mitochondrial function in PBMC and circulating levels of mtDNA; the improvement of the glucose picture and the lipid profile.
1 month after discharge, patients will carry out an outpatient check-up to evaluate the maintenance of muscle mass using impedance testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aminoacids | Active Comparator | Patients with obesity treated with essential aminoacids (EAA-AC) |
|
| Control | Placebo Comparator | Patients with obesity treated with placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminoacid supplementation | Dietary Supplement | Low-calorie and low-protein diet + with 4 sachets of EEA-AC supplement per day for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Muscle mass | Change in muscle mass during weight loss assessed through changes in body composition | At baseline and at 2 weeks after start of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 6 minute walking test (6MWT) | Change in distance covered in 6 minutes of walking during weight loss | At baseline and at 2 weeks after start of intervention |
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Inclusion Criteria:
- Obesity (BMI >35kg/m2)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amelia Brunani, MD | Contact | 390323514232 | brunani@auxologico.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Auxologico Italiano, Site Piancavallo | Recruiting | Oggebbio | Verbania | 28921 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15545607 | Background | Nisoli E, Falcone S, Tonello C, Cozzi V, Palomba L, Fiorani M, Pisconti A, Brunelli S, Cardile A, Francolini M, Cantoni O, Carruba MO, Moncada S, Clementi E. Mitochondrial biogenesis by NO yields functionally active mitochondria in mammals. Proc Natl Acad Sci U S A. 2004 Nov 23;101(47):16507-12. doi: 10.1073/pnas.0405432101. Epub 2004 Nov 15. |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| Placebo | Dietary Supplement | Low-calorie and low-protein diet + placebo for 2 weeks |
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |