Evaluating a very low-calorie ketogenic diet for weight loss and energy metabolism
Official title: Effect of Very Low Ketogenic Diet on Energy Metabolism in Women With Obesity
Run by University of Pisa · NCT06252077 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if a very low-calorie ketogenic diet can help women with obesity lose weight and improve how their bodies use energy over 28 days.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | University of Pisa Academic / other |
| Locations | 1 site (Pisa) |
| Trial ID | NCT06252077 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are females who are overweight or obese without any significant comorbidities.
✕Probably not a fit
Patients with diabetes, endocrine disorders, or other significant health issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of a very low-calorie ketogenic diet over 28 days in females with obesity, focusing on changes in body weight, body composition, and energy metabolism. Participants are recruited at the Obesity and Lipodystrophy Center at the University Hospital of Pisa and undergo a controlled diet within a metabolic chamber. Energy metabolism is measured at baseline, one week, and at the end of the study using a metabolic chamber, while body composition is assessed using total-body densitometry at the conclusion of the study.
Why it matters
Potential benefit: If successful, this approach could provide a new dietary intervention for weight management and improved energy metabolism in obese females.
How similar studies have gone: While ketogenic diets have been studied previously, this specific approach within a metabolic chamber is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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University Hospital of Pisa, Endocrinology Unit
Pisa, Italy Recruiting
Study contacts
- Principal investigator: Ferruccio Santini, MD — University of Pisa
- Study coordinator: Alessio Basolo, MD
- Email: alessio.basolo@unipi.it
- Phone: 050997334
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.