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NCT Number: NCT04322110

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

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.

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Key information

Conditions

Liver Fat Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PronoKal Method

Other

Multidisciplinary program of weight loss based on diet (initially ketogenic diet), physical activity and emotional support

low calorie diet

Other

Balanced hypocaloric diet (caloric intake 10% below basal metabolic rate) accompanied by physical exercise.

Primary outcomes

  1. Liver fatty infiltration at 6 months

    Time frame: 6 months

    Liver fatty infiltration percentage, measured by a MRI technique of fat liver quantification, fat at the end of treatment

Secondary outcomes

  1. Liver fatty infiltration at 2 months

    Time frame: 2 months

    Liver fatty infiltration percentage, measured by a MRI technique of fat liver quantification, at the end of ketosis

  2. Visceral fat at 2 months

    Time frame: 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.

  3. Visceral fat at 6 months

    Time frame: 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.

  4. Liver stiffness at 2 months

    Time frame: 2 months

    Liver stiffness detected by MR Elastography at the end of ketosis

  5. Liver stiffness at 6 months

    Time frame: 6 months

    Liver stiffness detected by MR Elastography at the end of treatment

  6. Size of adrenal gland at 2 months

    Time frame: 2 months

    Linear size in centimetres of adrenal gland at the end of ketosis, measured by MRI.

  7. Size of adrenal gland at 6 months

    Time frame: 6 months

    Linear size in centimetres of adrenal gland at the end of treatment, measured by MRI.

  8. Body Weight loss at 2 months

    Time frame: 2 months

    Change in body weight from baseline to end of ketosis.

  9. Body Weight loss at 6 months

    Time frame: 6 months

    Change in body weight from baseline to end of treatment.

  10. Salivary cortisol levels at 2 months

    Time frame: 2 months

    Salivary cortisol levels at the end of ketosis

  11. Salivary cortisol levels at 6 months

    Time frame: 6 months

    Salivary cortisol levels at the end of treatment

Sponsors and collaborators

Lead sponsor

Protein Supplies SL

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 26, 2020
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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