Very Low Ketogenic Diet and Energy Expenditure | NCT06252077

Studies
Very Low Ketogenic Diet and Energy Expenditure

NCT06252077

Sponsor

University of Pisa

Status

Completed

Last Update Posted

Jun 4, 2025Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Energy Metabolism

Interventions

very low ketogenic diet

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 16, 2022Actual

Primary Completion Date

Jan 16, 2024Actual

Completion Date

Mar 16, 2025Actual

First Submitted Date

Jan 23, 2024

First Submission Date that Met QC Criteria

Feb 6, 2024

First Posted Date

Feb 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2025

Last Update Posted Date

Jun 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
very low ketogenic diet	Experimental	patients with overweight and obesity in treatment for weight loss	Dietary Supplement: very low ketogenic diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
very low ketogenic diet	Dietary Supplement	1 month of active phase of very low ketogenic diet	very low ketogenic diet

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ferruccio Santini, MD	University of Pisa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Pisa, Endocrinology Unit		Pisa		56124	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided