Very Low Ketogenic Diet and Energy Expenditure

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Energy Metabolism

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Pisa, Endocrinology Unit

Pisa, 56124, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Very Low Ketogenic Diet

Dietary Supplement

1 month of active phase of very low ketogenic diet

Primary outcomes

measure of energy expenditure

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2025
First posted: Feb 9, 2024
Registry last updated: Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed