Very Low Ketogenic Diet and Energy Expenditure

Not Applicable

Recruiting

• Conditions: Energy Metabolism
• Interventions: Dietary Supplement: very low ketogenic diet

• Registration Number: NCT06252077
• Lead Sponsor: University of Pisa

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).

Study Timeline

• Study Start: 2022-06-16
• Primary Completion: 2024-01-16
• Study First Submitted: 2024-01-23
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-06
• Last Update Submitted: 2024-02-06
• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-09
• Study Completion: 2024-06-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• overweight and obesity

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
very low ketogenic diet	very low ketogenic diet	patients with overweight and obesity in treatment for weight loss

Primary Outcome Measures

Name	Time	Method
measure of energy expenditure	1 month	measures of energy expenditure (in kilocalories) will be assessed by using the metabolic chamber, 24-hour whole room indirect calorimeter. Thus, the measures will be expressed in Kilocalories over 24 hours.

Trial Locations

Locations (1)

University Hospital of Pisa, Endocrinology Unit; 🇮🇹 Pisa, Italy