NCT05898204

KEtogenic Diet and Its Multiple EffectS on Obesity

Comparison of the Effects of a Ketogenic Diet and an Isocaloric Balanced Diet in Obese Patients: a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The prevalence of obesity and metabolic disturbances is worryingly increasing worldwide, therefore the study of their pathophysiology is extremely important to find new strategies for their treatment. Obesity has a strong impact not only on the metabolism of the patients, but also may impact hormonal, inflammatory and immune profile, and profoundly influence the daily life of the patients. Weight loss may determine an amelioration of these parameters, but the impact of the diet composition aimed to weight loss on them has not been profoundly studied yet. The aim of our research project is to study the effects of a ketogenic diet in comparison with an isocaloric balanced diet on weight loss and anthropometric parameters, quality of life, hormone profile, sleep, sexual function, circadian rhythm, inflammatory and immunological parameters in obese patients.

Conditions

• Obesity

Interventions

Type	Name	Description
OTHER	Ketogenic diet	Prescription of a ketogenic diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day.
OTHER	Balanced diet	Prescription of a balanced diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day.

Timeline

• Start date: 2022-02-03
• Primary completion: 2022-05-06
• Completion: 2022-06-23
• First posted: 2023-06-12
• Last updated: 2025-08-14

Locations

1 site across 1 country: Italy