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

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ClinicalTrials.gov Identifier: NCT04322110
Recruitment Status : Completed
First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Liver Fat Other: PronoKal Method Other: Low calorie diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 12, 2016
Actual Primary Completion Date : July 4, 2017
Actual Study Completion Date : October 25, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VLCK diet group
Subjects undergoing treatment with weight loss program PronoKal Method
Other: PronoKal Method
Multidisciplinary program of weight loss based on diet (initially ketogenic diet), physical activity and emotional support

Active Comparator: Control group
Subjects undergoing treatment with low calorie diet
Other: Low calorie diet
Balanced hypocaloric diet (caloric intake 10% below basal metabolic rate) accompanied by physical exercise.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322110


Sponsors and Collaborators
Protein Supplies SL
Investigators
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Principal Investigator: Walmir Coutinho, Ph IEDE - Instituto Estadual de Diabetes e Endocrinologia
Principal Investigator: Guilherme Moura da Cunha, Ph CDPI - Clínica de Diagnóstico por Imagen
  Study Documents (Full-Text)

Documents provided by Protein Supplies SL:
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Responsible Party: Protein Supplies SL
ClinicalTrials.gov Identifier: NCT04322110    
Other Study ID Numbers: PNK-FATLIV-2016-04
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: May 2016

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Protein Supplies SL:
Low-Calorie-Ketogenic diet
Low Calorie Diet
Pronokal Method®
Fat reduction