Long Term Effect of VLCKD on Body Composition and 24-hour... | NCT07418281

Studies
Long Term Effect of VLCKD on Body Composition and 24-hour Energy Metabolism

NCT07418281

Sponsor

University of Pisa

Status

Completed

Last Update Posted

Feb 18, 2026Actual

Enrollment

17Actual

Phase

Not provided

Conditions

Obesity & Overweight

Interventions

follow up after very low calorie 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

Feb 2026

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

Oct 15, 2022Actual

Primary Completion Date

Sep 15, 2025Actual

Completion Date

Oct 15, 2025Actual

First Submitted Date

Feb 10, 2026

First Submission Date that Met QC Criteria

Feb 10, 2026

First Posted Date

Feb 18, 2026Actual

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

Feb 10, 2026

Last Update Posted Date

Feb 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

evaluation of body weight in patients with obesity after VLCKD

Detailed Description

evaluation of body weight, body composition and energy metabolism after 6 and 12 month from initiation of VLCKD

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with obesity		patients with obesity	Behavioral: follow up after very low calorie ketogenic diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
follow up after very low calorie ketogenic diet	Behavioral	follow up after very low calorie ketogenic diet	patients with obesity

Measure	Description	Time Frame
body weight evaluation		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

obesity

Exclusion Criteria:

diabetes

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

patients with obesity without diabetes

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Univeristy Hospital of Pisa		Pisa		56124	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42297602	Derived	Basolo A, Piaggi P, Angeli V, Fierabracci P, Bologna C, Paolucci G, Salvetti G, Chiovato L, Krakoff J, Landi A, Santini F. Six- and Twelve-Month Changes in Body Composition and 24-h Energy Expenditure After a Very Low-Calorie Ketogenic Diet. Obesity (Silver Spring). 2026 Jun 15. doi: 10.1002/oby.70236. Online ahead of print.

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

ID	Term
D009765	Obesity
D050177	Overweight