Clinical trial NCT04322110: MR Fat Quantification and Elastography During a Very Low-calorie-ketogenic Diet (Pronokal Method®) vs a Low Calorie Diet
Official title: Pilot Study Fatty Liver and Obesity: MR Fat Quantification and MR Elastography During a Very Low-calorie-ketogenic Diet (Pronokal Method®) Versus a Low Calorie Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Fat
Keywords: Low-Calorie-Ketogenic diet
Low Calorie Diet
Pronokal Method®
Fat reduction
Lead sponsor: Protein Supplies SL
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients of either sex, older than 18 years
* Obese patients with BMI equal or over 30kg/m2
* Patients who agree to participate and sign the Informed Consent

Exclusion Criteria:

* Pregnant or lactating women.
* Patients weighing over 140 kg (by limitation of the MRI device)
* Patients on anti-obesity drugs (eg, sibutramine, orlistat and liraglutide) or weight-interfering medications (eg, topiramate). In such cases a wash out period of 3 months is required.
* Patients with alcohol intake \> 20 g/day in women and \> 30 g/day in men.
* Patients with liver failure or with pathologies that may affect the liver
* Patients with other causes of liver steatosis: chronic viral hepatitis and/or drug intake (corticosteroids, estrogens, NSAIDs, calcium antagonists, amiodarone, tamoxifen, tetracyclines, chloroquine, antiretrovirals, perhexiline).
* Patients with eating disorders.
* Patients with any psychiatric disorder (eg schizophrenia, bipolar disorder, substance abuse, severe depression).
* Patients receiving dicumarinic anticoagulants (Sintrom®).
* Patients taking corticosteroids.
* Patients with severe kidney failure (gfr \<30).
* Patients with type 1 and type 2 diabetes mellitus.
* Patients with hemopathies, including coagulation disorders
* Patients with cardiovascular or cerebrovascular disease (of heart rate disorders, recent infarction \[\<6m\], unstable angina, decompensated heart failure, recent stroke \[\<6m\]).
* Patients in acute attack of gout.
* Patients with renal lithiasis verified by ultrasound.
* Patients with cholelithiasis verified by ultrasound.
* Patients with electrolyte imbalance, according to medical criteria.
* Patients with orthostatic hypotension.
* Patients with cancer or history of cancer who have not been discharged from oncology
* Patients who are not expected to attend follow-up visits

Primary outcomes:
measure: Liver fatty infiltration at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Liver fatty infiltration at 2 months
timeFrame: 2 months
measure: Visceral fat at 2 months
timeFrame: 2 months
measure: Visceral fat at 6 months
timeFrame: 6 months
measure: Liver stiffness at 2 months
timeFrame: 2 months
measure: Liver stiffness at 6 months
timeFrame: 6 months
measure: Size of adrenal gland at 2 months
timeFrame: 2 months
measure: Size of adrenal gland at 6 months
timeFrame: 6 months
measure: Body Weight loss at 2 months
timeFrame: 2 months
measure: Body Weight loss at 6 months
timeFrame: 6 months
measure: Salivary cortisol levels at 2 months
timeFrame: 2 months
measure: Salivary cortisol levels at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: IEDE - Instituto Estadual de Diabetes e Endocrinologia
name: Walmir Coutinho, Ph
role: PRINCIPAL_INVESTIGATOR
affiliation: CDPI - Clínica de Diagnóstico por Imagen
name: Guilherme Moura da Cunha, Ph
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.