Energy MetabolismNCT06252077
Very Low Ketogenic Diet and Energy Expenditure
A study testing very low ketogenic diet in people with Energy Metabolism, run by University of Pisa at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Metabolism
- What is being tested?
- very low ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jun 2022to 16 Mar 2025
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- overweight and obesity
Who cannot join
- Type 1 and type 2 diabetes mellitus
- endocrine disorders
- asthma or pulmonary conditions
- cardiovascular disease
- gastrointestinal disease
- liver disease
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Very Low Ketogenic Diet on Energy Metabolism in Women With Obesity
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.
Read the 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).
- Conditions
- Energy Metabolism
- Being tested
- very low ketogenic diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
very low ketogenic dietDietary supplement
1 month of active phase of very low ketogenic diet
| Study group | Role | What they receive |
|---|---|---|
| very low ketogenic diet | Experimental | patients with overweight and obesity in treatment for weight loss Receives: Dietary Supplement: very low ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start16 Jun 2022
- Primary completion16 Jan 2024
- Study completion16 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy MetabolismStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- body weight loss
- Masking
- None (open label)
- Enrolment
- 20 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
- Investigators
- Ferruccio Santini, MD, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252077
- Sponsor's protocol ID
- EECR
- Status last verified
- May 2025
- First submitted
- 23 Jan 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Very Low Ketogenic Diet on Energy Metabolism in Women With Obesity
- ClinicalTrials.gov ID
- NCT06252077
- Acronym / sponsor ID
- EECR
- Conditions
- Energy Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 16 Mar 2025 (actual)
- First posted
- 9 Feb 2024 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- body weight loss
| Arm | Type | Receives |
|---|---|---|
| very low ketogenic diet | Experimental | Dietary Supplement: very low ketogenic dietpatients with overweight and obesity in treatment for weight loss |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- overweight and obesity
Key exclusion criteria (17 listed)
- Type 1 and type 2 diabetes mellitus
- endocrine disorders
- asthma or pulmonary conditions
- cardiovascular disease
- gastrointestinal disease
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 |
|---|---|---|
| very low ketogenic diet1 month of active phase of very low ketogenic diet | Dietary supplement | very low ketogenic diet |
Primary outcome
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.
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 4 Jun 2025.
- 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.
Ferruccio Santini, MD principal investigator
University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing very low ketogenic diet in people with Energy Metabolism, 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 17 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 4 Jun 2025. 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?
measure of energy expenditure (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2025.