Liver FatNCT04322110
MR Fat Quantification and Elastography During a Very Low-calorie-ketogenic Diet (Pronokal Method®) vs a Low Calorie Diet
A study testing PronoKal Method and Low calorie diet in people with Liver Fat, run by Protein Supplies SL.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Fat
- What is being tested?
- PronoKal Method and Low calorie diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 12 Sep 2016to 25 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
About this study
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
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.
Read the 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.
- Conditions
- Liver Fat
- Being tested
- PronoKal Method, Low calorie diet
- Keywords
- Low-Calorie-Ketogenic diet, Low Calorie Diet, Pronokal Method®, Fat reduction
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PronoKal MethodOther
Multidisciplinary program of weight loss based on diet (initially ketogenic diet), physical activity and emotional support
Low calorie dietOther
Balanced hypocaloric diet (caloric intake 10% below basal metabolic rate) accompanied by physical exercise.
| Study group | Role | What they receive |
|---|---|---|
| VLCK diet group | Experimental | Subjects undergoing treatment with weight loss program PronoKal Method Receives: Other: PronoKal Method |
| Control group | Active comparator | Subjects undergoing treatment with low calorie diet Receives: Other: Low calorie diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (11)
Liver fatty infiltration at 2 months
Liver fatty infiltration percentage, measured by a MRI technique of fat liver quantification, at the end of ketosis
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 6 months
Liver stiffness at 2 months
Liver stiffness detected by MR Elastography at the end of ketosis
Measured: 2 months
Liver stiffness at 6 months
Liver stiffness detected by MR Elastography at the end of treatment
Measured: 6 months
Size of adrenal gland at 2 months
Linear size in centimetres of adrenal gland at the end of ketosis, measured by MRI.
Measured: 2 months
Size of adrenal gland at 6 months
Linear size in centimetres of adrenal gland at the end of treatment, measured by MRI.
Measured: 6 months
Body Weight loss at 2 months
Change in body weight from baseline to end of ketosis.
Measured: 2 months
Body Weight loss at 6 months
Change in body weight from baseline to end of treatment.
Measured: 6 months
Salivary cortisol levels at 2 months
Salivary cortisol levels at the end of ketosis
Measured: 2 months
Salivary cortisol levels at 6 months
Salivary cortisol levels at the end of treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start12 Sep 2016
- Primary completion4 Jul 2017
- Study completion25 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver FatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protein Supplies SL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Walmir Coutinho, Ph, Principal investigator, IEDE - Instituto Estadual de Diabetes e EndocrinologiaGuilherme Moura da Cunha, Ph, Principal investigator, CDPI - Clínica de Diagnóstico por Imagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322110
- Sponsor's protocol ID
- PNK-FATLIV-2016-04
- Status last verified
- May 2016
- First submitted
- 13 Mar 2020
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33042004
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04322110
- Acronym / sponsor ID
- PNK-FATLIV-2016-04
- Conditions
- Liver Fat
- Keywords
- Low-Calorie-Ketogenic diet, Low Calorie Diet, Pronokal Method®, Fat reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Protein Supplies SLUniversity, hospital or other
- Study start
- 12 Sep 2016 (actual)
- Primary completion
- 4 Jul 2017 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VLCK diet group | Experimental | Other: PronoKal MethodSubjects undergoing treatment with weight loss program PronoKal Method |
| Control group | Active comparator | Other: Low calorie dietSubjects undergoing treatment with low calorie diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PronoKal MethodMultidisciplinary program of weight loss based on diet (initially ketogenic diet), physical activity and emotional support | Other | VLCK diet group |
| Low calorie dietBalanced hypocaloric diet (caloric intake 10% below basal metabolic rate) accompanied by physical exercise. | Other | Control group |
Primary outcome
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
11 secondary outcomes
Liver fatty infiltration at 2 months
Time frame: 2 months
Visceral fat at 2 months
Time frame: 2 months
Visceral fat at 6 months
Time frame: 6 months
Liver stiffness at 2 months
Time frame: 2 months
Liver stiffness at 6 months
Time frame: 6 months
Size of adrenal gland at 2 months
Time frame: 2 months
Size of adrenal gland at 6 months
Time frame: 6 months
Body Weight loss at 2 months
Time frame: 2 months
Body Weight loss at 6 months
Time frame: 6 months
Salivary cortisol levels at 2 months
Time frame: 2 months
Salivary cortisol levels at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Derived from this study: PubMed 33042004Cunha 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walmir Coutinho, Ph principal investigator
IEDE - Instituto Estadual de Diabetes e Endocrinologia
Guilherme Moura da Cunha, Ph principal investigator
CDPI - Clínica de Diagnóstico por Imagen
Questions about this trial
What is this clinical trial studying?
A study testing PronoKal Method and Low calorie diet in people with Liver Fat, run by Protein Supplies SL.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver fatty infiltration at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04322110, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020; AzTrials last refreshed its copy on 31 Oct 2026.