Obesity & OverweightVLCKDFUNCT07418281
Long Term Effect of VLCKD on Body Composition and 24-hour Energy Metabolism
An observational study of Obesity & Overweight, run by University of Pisa at 1 site in Italy.
Trial summary
evaluation of body weight in patients with obesity after VLCKD Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- follow up after very low calorie ketogenic diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 17 participants
- Where
- 1 siteItaly
- Study dates
- 15 Oct 2022to 15 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with obesity without diabetes
Who may be able to join
- obesity
Who cannot join
- diabetes
Trial locations and contacts
1 site in 1 country.
About this study
evaluation of body weight in patients with obesity after VLCKD
Read the detailed description
evaluation of body weight, body composition and energy metabolism after 6 and 12 month from initiation of VLCKD
- Conditions
- Obesity & Overweight
- Being tested
- follow up after very low calorie ketogenic diet
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow up after very low calorie ketogenic dietBehavioural
follow up after very low calorie ketogenic diet
| Study group | Role | What they receive |
|---|---|---|
| patients with obesity | patients with obesity Receives: Behavioral: follow up after very low calorie ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight evaluation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start15 Oct 2022
- Primary completion15 Sep 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessio Basolo, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418281
- Sponsor's protocol ID
- VLCKD FU
- Acronym
- VLCKDFU
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Aug;34(8):1558-1568. doi: 10.1002/oby.70236. Epub 2026 Jun 15.
PubMed 42297602
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effect of VLCKD on Body Composition and 24-hour Energy Metabolism
- ClinicalTrials.gov ID
- NCT07418281
- Acronym / sponsor ID
- VLCKDFU / VLCKD FU
- Conditions
- Obesity & Overweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with obesity | – | Behavioral: follow up after very low calorie ketogenic dietpatients with obesity |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with obesity without diabetes
Key inclusion criteria (1 listed)
- obesity
Key exclusion criteria (1 listed)
- diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| follow up after very low calorie ketogenic dietfollow up after very low calorie ketogenic diet | Behavioural | patients with obesity |
Primary outcome
body weight evaluation
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Derived from this study: PubMed 42297602Basolo 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 Aug;34(8):1558-1568. doi: 10.1002/oby.70236. Epub 2026 Jun 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity & Overweight, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body weight evaluation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07418281, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.