An interventional study of PronoKal Method and Low calorie diet in Liver Fat, sponsored by Protein Supplies SL. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-26.
Sponsored by Protein Supplies SL · Not applicable, Interventional, and Treatment
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.
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.
Protein Supplies SL is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects undergoing treatment with weight loss program PronoKal Method
Other: PronoKal Method
Subjects undergoing treatment with low calorie diet
Other: Low calorie diet
Multidisciplinary program of weight loss based on diet (initially ketogenic diet), physical activity and emotional support
Balanced hypocaloric diet (caloric intake 10% below basal metabolic rate) accompanied by physical exercise.
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
Time frame: 6 months
Liver fatty infiltration at 2 months
Liver fatty infiltration percentage, measured by a MRI technique of fat liver quantification, at the end of ketosis
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Liver stiffness at 2 months
Liver stiffness detected by MR Elastography at the end of ketosis
Time frame: 2 months
Liver stiffness at 6 months
Liver stiffness detected by MR Elastography at the end of treatment
Time frame: 6 months
Size of adrenal gland at 2 months
Linear size in centimetres of adrenal gland at the end of ketosis, measured by MRI.
Time frame: 2 months
Size of adrenal gland at 6 months
Linear size in centimetres of adrenal gland at the end of treatment, measured by MRI.
Time frame: 6 months
Body Weight loss at 2 months
Change in body weight from baseline to end of ketosis.
Time frame: 2 months
Body Weight loss at 6 months
Change in body weight from baseline to end of treatment.
Time frame: 6 months
Salivary cortisol levels at 2 months
Salivary cortisol levels at the end of ketosis
Time frame: 2 months
Salivary cortisol levels at 6 months
Salivary cortisol levels at the end of treatment
Time frame: 6 months
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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