Very Low Ketogenic Diet and Energy Expenditure

NCT ID: NCT06252077

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-16
• Study Completion Date: 2025-03-16

Brief Summary

This study aimed at evaluating the effectiveness of the active phase of a very low-calorie ketogenic diet in females with obesity lasting 28 days on body weight, body composition and energy metabolism using a metabolic chamber.

Detailed Description

Patients were recruited at the Obesity and Lipodystrophy Center, University Hospital of Pisa. Enrolled subjects underwent active phase of very low-calorie ketogenic diet within the metabolic chamber from day 0 for a duration of 4 weeks (day 0-28). On days 0, 7, and 28, patients underwent a 24-hour measurement of energy metabolism using the metabolic chamber. On the day of exit from the chamber measurement of body composition was conducted using total-body densitometry (Lunar iDXA; GE Healthcare).

Conditions

Energy Metabolism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

very low ketogenic diet

patients with overweight and obesity in treatment for weight loss

Group Type: EXPERIMENTAL

very low ketogenic diet

Intervention Type: DIETARY_SUPPLEMENT

1 month of active phase of very low ketogenic diet

Interventions

very low ketogenic diet

1 month of active phase of very low ketogenic diet

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• overweight and obesity

Exclusion Criteria

• Type 1 and type 2 diabetes mellitus
• endocrine disorders
• asthma or pulmonary conditions
• cardiovascular disease
• gastrointestinal disease
• liver disease
• kidney diseases
• anemia (hemoglobin < 11 g/dL)
• leucopenia (white blood cells < 4,000/mcL)
• thrombocytopenia (platelets < 150,000/mcL)
• central nervous system disorders
• neurodegenerative diseases
• psychiatric disorders
• eating disorders
• alcohol abuse and substance dependence
• pregnancy
• lactation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pisa

OTHER

Sponsor Role: lead

Responsible Party

Alessio Basolo

Researcher, PhD, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ferruccio Santini, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pisa

Locations

University Hospital of Pisa, Endocrinology Unit

Pisa, , Italy

Countries

Italy

Other Identifiers

EECR

Identifier Type: -

Identifier Source: org_study_id