CompletedNot Applicable

Adherence and Tolerability of Four Very Low-Calorie Ketogenic Diet Approaches in Adults With Obesity or Complicated Overweight

Italy110 participantsStarted 2021-07-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adherence, collateral effects, drop-out, dietetic compliance

Timeframe: Until the end of the study

Trial details

NCT IDNCT07389122

SponsorUniversity of Bologna

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-08-20

View on ClinicalTrials.gov More Obesity & Overweight trials