NCT04322110

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
Last Updated

March 26, 2020

Status Verified

May 1, 2016

Enrollment Period

10 months

First QC Date

March 13, 2020

Last Update Submit

March 23, 2020

Conditions

Liver Fat

Keywords

Low-Calorie-Ketogenic dietLow Calorie DietPronokal Method®Fat reduction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Liver fatty infiltration at 2 months

    2 months

  • Visceral fat at 2 months

    2 months

  • Visceral fat at 6 months

    6 months

  • Liver stiffness at 2 months

    2 months

  • Liver stiffness at 6 months

    6 months

  • +6 more secondary outcomes

Study Arms (2)

VLCK diet group

EXPERIMENTAL

Subjects undergoing treatment with weight loss program PronoKal Method

Other: PronoKal Method

Control group

ACTIVE COMPARATOR

Subjects undergoing treatment with low calorie diet

Other: Low calorie diet

Interventions

PronoKal MethodOTHER

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

VLCK diet group
Low calorie dietOTHER

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 33042004DERIVED

MeSH Terms

Conditions

Fatty Liver

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Walmir Coutinho, Ph

    IEDE - Instituto Estadual de Diabetes e Endocrinologia

    PRINCIPAL INVESTIGATOR

  • Guilherme Moura da Cunha, Ph

    CDPI - Clínica de Diagnóstico por Imagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2020

First Posted

March 26, 2020

Study Start

September 12, 2016

Primary Completion

July 4, 2017

Study Completion

October 25, 2017

Last Updated

March 26, 2020

Record last verified: 2016-05