Very Low Ketogenic Diet and Energy Expenditure

University of Pisa

Status: Completed

Conditions: Energy Metabolism

Treatments: Dietary Supplement: very low ketogenic diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06252077

EECR

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

very low ketogenic diet

Experimental group

Description:

patients with overweight and obesity in treatment for weight loss

Treatment:

Dietary Supplement: very low ketogenic diet