Very Low Ketogenic Diet and Energy Expenditure

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06252077

Enrollment

Registered

2024-02-09

Start date

2022-06-16

Completion date

2025-03-16

Last updated

2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Energy Metabolism

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).

Interventions

DIETARY_SUPPLEMENTvery low ketogenic diet

1 month of active phase of very low ketogenic diet

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

body weight loss

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026