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

NCT07389122 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • Obesity & Overweight
  • MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)
  • Type 2 Diabetes
  • Insulin Resistance

Sponsors & Collaborators

  • S. Orsola-Malpighi Hospital, University of Bologna

    collaborator UNKNOWN

  • University of Bologna

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2024-08-20
Completion
2025-06-30

Countries

  • Italy

Study Locations

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Entities

Diseases

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 NCT07389122 on ClinicalTrials.gov