Very Low Ketogenic Diet and Energy Expenditure

Effect of Very Low Ketogenic Diet on Energy Metabolism in Women With Obesity

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.

Study Overview

• Status: Recruiting
• Conditions: Energy Metabolism
• Intervention / Treatment: Dietary supplement: very low ketogenic diet

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessio Basolo, MD; Phone Number: 050997334; Email: alessio.basolo@unipi.it
• Study Contact Backup: Name: Ferruccio Santini, MD; Phone Number: 050995001; Email: ferruccio.santini@unipi.it

Study Locations

• Italy
  • Pisa, Italy, 56124
    • Recruiting
    • University Hospital of Pisa, Endocrinology Unit
    • Contact: Alessio Basolo, MD; Phone Number: 050997334; Email: alessio.basolo@unipi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: very low ketogenic diet; patients with overweight and obesity in treatment for weight loss	Dietary supplement: very low ketogenic diet; 1 month of active phase of very low ketogenic diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measure of energy expenditure	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.	1 month

Collaborators and Investigators

• Sponsor: University of Pisa
• Investigators: Principal Investigator: Ferruccio Santini, MD, University of Pisa

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2022
• Primary Completion (Actual): January 16, 2024
• Study Completion (Estimated): June 16, 2024

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Estimated): February 9, 2024

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EECR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No