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NCT06252077 Clinical Trial

Very Low Ketogenic Diet and Energy Expenditure

Energy Metabolism Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06252077
Other study ID # EECR
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 16, 2022
Est. completion date June 16, 2024

Study information
Verified date February 2024
Source University of Pisa
Contact Alessio Basolo, MD
Phone 050997334
Email alessio.basolo@unipi.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date June 16, 2024
Est. primary completion date January 16, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• very low ketogenic diet
1 month of active phase of very low ketogenic diet

Locations
Country Name City State
Italy University Hospital of Pisa, Endocrinology Unit Pisa

Sponsors (1)
Lead Sponsor Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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