MR Fat Quantification and Elastography During a Very Low-calorie-ketogenic Diet (Pronokal Method®) vs a Low Calorie Diet

Not Applicable

Completed

• Conditions: Liver Fat
• Interventions: Other: Low calorie diet; Other: PronoKal Method

• Registration Number: NCT04322110
• Lead Sponsor: Protein Supplies SL

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.

Study Timeline

• Status Verified: 2016-05
• Study Start: 2016-09-12
• Primary Completion: 2017-07-04
• Study Completion: 2017-10-25
• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-23
• Last Update Submitted: 2020-03-23
• Study First Posted: 2020-03-26
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Low calorie diet	Subjects undergoing treatment with low calorie diet
VLCK diet group	PronoKal Method	Subjects undergoing treatment with weight loss program PronoKal Method

Primary Outcome Measures

Name	Time	Method
Liver fatty infiltration at 6 months	6 months	Liver fatty infiltration percentage, measured by a MRI technique of fat liver quantification, fat at the end of treatment

Secondary Outcome Measures

Name	Time	Method
Liver fatty infiltration at 2 months	2 months	Liver fatty infiltration percentage, measured by a MRI technique of fat liver quantification, at the end of ketosis
Visceral fat at 2 months	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.
Visceral fat at 6 months	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.
Liver stiffness at 2 months	2 months	Liver stiffness detected by MR Elastography at the end of ketosis
Liver stiffness at 6 months	6 months	Liver stiffness detected by MR Elastography at the end of treatment
Size of adrenal gland at 2 months	2 months	Linear size in centimetres of adrenal gland at the end of ketosis, measured by MRI.
Size of adrenal gland at 6 months	6 months	Linear size in centimetres of adrenal gland at the end of treatment, measured by MRI.
Body Weight loss at 2 months	2 months	Change in body weight from baseline to end of ketosis.
Body Weight loss at 6 months	6 months	Change in body weight from baseline to end of treatment.
Salivary cortisol levels at 2 months	2 months	Salivary cortisol levels at the end of ketosis
Salivary cortisol levels at 6 months	6 months	Salivary cortisol levels at the end of treatment