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Prospective, multicenter, open-label, randomized and controlled study of the effects of weight loss and reduced visceral fat on non-alcoholic fat infiltration into liver after a very low calorie ketogenic diet (VLCK diet) (Pronokal® Method) versus a hypocaloric diet, with a 6-month follow-up.
The investigators will include obese patients with BMI higher than 30 kg / m2 to follow a standardized multidisciplinary weight-loss program (PronoKal® Method), which consists of a very-low-calorie diet, into which natural foods are gradually reintroduced, accompanied by physical exercise and emotional support, versus hypocaloric diet.
The aim of this study are see the reduction of fatty liver, visceral fat and improvement of hepatic stiffness during the weight loss treatment.
Patients will be visited monthly and data will recorded on 4 occasions: pre-inclusion, initial visit, 2-months visit (end of ketosis) and 6-months visit.
Hepatic fatty infiltration and visceral fat will be scanned by MRI and hepatic stiffness will be assessed by MR Elastography at: baseline, 2 months and 6 months. Also will be recorded anthropometric data (weight, BMI, waist circumference) and complete blood tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VLCK diet group | Experimental | Subjects undergoing treatment with weight loss program PronoKal Method |
|
| Control group | Active Comparator | Subjects undergoing treatment with low calorie diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PronoKal Method | Other | Multidisciplinary program of weight loss based on diet (initially ketogenic diet), physical activity and emotional support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Liver fatty infiltration at 6 months | Liver fatty infiltration percentage, measured by a MRI technique of fat liver quantification, fat at the end of treatment | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Liver fatty infiltration at 2 months | Liver fatty infiltration percentage, measured by a MRI technique of fat liver quantification, at the end of ketosis | 2 months |
| Visceral fat at 2 months | Viceral fat measured by the area in squared centimeters at the level of the 3rd vertebrae, using MRI technique, at the end of ketosis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walmir Coutinho, Ph | IEDE - Instituto Estadual de Diabetes e Endocrinologia | Principal Investigator |
| Guilherme Moura da Cunha, Ph | CDPI - ClÃnica de Diagnóstico por Imagen | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33042004 | Derived | Cunha GM, Guzman G, Correa De Mello LL, Trein B, Spina L, Bussade I, Marques Prata J, Sajoux I, Countinho W. Efficacy of a 2-Month Very Low-Calorie Ketogenic Diet (VLCKD) Compared to a Standard Low-Calorie Diet in Reducing Visceral and Liver Fat Accumulation in Patients With Obesity. Front Endocrinol (Lausanne). 2020 Sep 14;11:607. doi: 10.3389/fendo.2020.00607. eCollection 2020. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2016 | Nov 2, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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| Low calorie diet | Other | Balanced hypocaloric diet (caloric intake 10% below basal metabolic rate) accompanied by physical exercise. |
|
| 2 months |
| Visceral fat at 6 months | Viceral fat measured by the area in squared centimeters at the level of the 3rd vertebrae, using MRI technique, at the end of treatment. | 6 months |
| Liver stiffness at 2 months | Liver stiffness detected by MR Elastography at the end of ketosis | 2 months |
| Liver stiffness at 6 months | Liver stiffness detected by MR Elastography at the end of treatment | 6 months |
| Size of adrenal gland at 2 months | Linear size in centimetres of adrenal gland at the end of ketosis, measured by MRI. | 2 months |
| Size of adrenal gland at 6 months | Linear size in centimetres of adrenal gland at the end of treatment, measured by MRI. | 6 months |
| Body Weight loss at 2 months | Change in body weight from baseline to end of ketosis. | 2 months |
| Body Weight loss at 6 months | Change in body weight from baseline to end of treatment. | 6 months |
| Salivary cortisol levels at 2 months | Salivary cortisol levels at the end of ketosis | 2 months |
| Salivary cortisol levels at 6 months | Salivary cortisol levels at the end of treatment | 6 months |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |