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

Liver Fat Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04322110
• Other study ID #: PNK-FATLIV-2016-04
• Status: Completed
• Phase: N/A
• Start date: September 12, 2016
• Est. completion date: October 25, 2017

Study information

• Verified date: May 2016
• Source: Protein Supplies SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 25, 2017
• Est. primary completion date: July 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Fat

Intervention

Other:
• PronoKal Method
Multidisciplinary program of weight loss based on diet (initially ketogenic diet), physical activity and emotional support
• Low calorie diet
Balanced hypocaloric diet (caloric intake 10% below basal metabolic rate) accompanied by physical exercise.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Protein Supplies SL

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	2 months
Secondary	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
Secondary	Liver stiffness at 2 months	Liver stiffness detected by MR Elastography at the end of ketosis	2 months
Secondary	Liver stiffness at 6 months	Liver stiffness detected by MR Elastography at the end of treatment	6 months
Secondary	Size of adrenal gland at 2 months	Linear size in centimetres of adrenal gland at the end of ketosis, measured by MRI.	2 months
Secondary	Size of adrenal gland at 6 months	Linear size in centimetres of adrenal gland at the end of treatment, measured by MRI.	6 months
Secondary	Body Weight loss at 2 months	Change in body weight from baseline to end of ketosis.	2 months
Secondary	Body Weight loss at 6 months	Change in body weight from baseline to end of treatment.	6 months
Secondary	Salivary cortisol levels at 2 months	Salivary cortisol levels at the end of ketosis	2 months
Secondary	Salivary cortisol levels at 6 months	Salivary cortisol levels at the end of treatment	6 months