Insulin Resistance, MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), Obesity & Overweight, Type 2 Diabetes
Conditions
Keywords
ketogenic diet, meal replacement, pragmatic study, real-world evidence, obesity management, very-low-energy ketogenic therapy, weight loss
Brief summary
This study, called KOBE Study, looks at how well different very low-calorie ketogenic diets (VLCKD) are followed and tolerated by adults with obesity or complicated overweight in routine clinical practice. Ketogenic diets are medical nutrition therapies that greatly reduce carbohydrates and calories to promote weight loss and improve metabolic health. Several VLCKD approaches are used in clinical care, but they differ in the type of protein sources used (natural foods versus meal replacements or supplements). At present, there is limited evidence comparing these approaches in terms of adherence, side effects, satisfaction, and dropout rates. The KOBE Study is a single-center, prospective, observational study conducted during standard clinical care at a hospital nutrition clinic. Participants choose one of four VLCKD protocols based on personal preference: * diets using only natural protein foods, * natural proteins plus one protein supplement, * natural proteins plus two meal replacements, * or diets based entirely on meal replacements. All participants follow the same structured program lasting about 26 weeks (longer for individuals with severe obesity), consisting of: 1. an initial ketogenic phase, 2. a gradual reintroduction of carbohydrates, 3. a maintenance phase based on a low-glycemic index Mediterranean-style diet. Throughout the study, patients undergo routine clinical visits and assessments, including measurements of body weight, body composition, blood tests, liver imaging, and questionnaires on hunger, bowel habits, quality of life, and satisfaction with the diet. No additional tests beyond standard care are required. The main goal of the study is to compare the different ketogenic protocols in terms of: * how well patients can follow them, * how well they are tolerated, * the occurrence of side effects, * and overall satisfaction. Secondary objectives include evaluating changes in body composition, metabolic parameters, and liver health. The results of this study aim to help patients and healthcare professionals make more informed, evidence-based decisions when choosing among different ketogenic diet options for weight management and metabolic disease.
Interventions
None listed
Sponsors
University of Bologna
S. Orsola-Malpighi Hospital, University of Bologna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Obesity with or without comorbidities (BMI ≥ 30 kg/m²) OR * Overweight with comorbidity of MASLD (BMI 25.0-29.9 kg/m²) PLUS * Previous unsuccessful attempt at a prescribed hypocaloric diet
Exclusion criteria
* Age \< 18 years * Pregnancy * Breastfeeding * Moderate or severe kidney failure * Cardiovascular diseases: heart failure (NYHA III-IV), unstable angina, acute coronary syndrome or stroke within the past 12 months, paroxysmal atrial fibrillation, any type of atrioventricular block, left bundle branch block * Liver diseases: Child-Pugh C, elevated transaminases with AST or ALT ≥ 5 times the upper limit of normal, INR ≥ 1.5, total bilirubin ≥ 2 mg/dL * Diabetes: type 1 diabetes mellitus, type 2 diabetes mellitus with insufficient pancreatic endocrine reserve (C-peptide \< 0.8 ng/mL), type 2 diabetes mellitus on multiple daily insulin injections * Last attempt of VLCKD outside the research protocol within the past 12 months * Eating disorders: anorexia nervosa, bulimia nervosa, binge eating disorder * Psychiatric comorbidities, alcohol or substance dependence * Frail elderly patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence, collateral effects, drop-out, dietetic compliance | Until the end of the study | The primary objective of the study is to evaluate, within routine clinical practice and by comparing four distinct VLCKD protocols, the therapeutic response of patients in terms of: (i) adherence (compliance), (ii) occurrence of adverse events, (iii) drop-out rate, and (iv) diet satisfaction. The four ketogenic protocols routinely used in patients undergoing VLCKD each consist of three phases; only the first phase differs among protocols, based on patients' personal preferences. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometric Measures, Body Composition, Laboratory Parameters, and Imaging Evaluations | Until the end of the study | The secondary objectives are to evaluate the effects of the different VLCKD protocol arms on the trends of parameters collected during routine clinical practice, including: (i) first- and second-level anthropometric measurements (body weight, Body Mass Index (BMI), and circumferences); (ii) body composition; (iii) biochemical laboratory tests according to the Società italiana di Endocrinologia (SIE) Consensus Statement, with particular attention to serum creatinine levels. (iv) upper abdominal ultrasound and hepatic-splenic transient elastography assessed using the FibroScan technique. |
Countries
Italy
Outcome results
None listed