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

NCT04322110 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-03-26

No results posted yet for this study

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.

Conditions

  • Liver Fat

Interventions

OTHER

PronoKal Method

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

OTHER

Low calorie diet

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

Sponsors & Collaborators

  • Protein Supplies SL

    lead OTHER

Principal Investigators

  • Walmir Coutinho, Ph · IEDE - Instituto Estadual de Diabetes e Endocrinologia

  • Guilherme Moura da Cunha, Ph · CDPI - Clínica de Diagnóstico por Imagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-12
Primary Completion
2017-07-04
Completion
2017-10-25

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04322110 on ClinicalTrials.gov