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CompletedNCT06252077Updated Jun 4, 2025

Very Low Ketogenic Diet and Energy Expenditure

An interventional study of very low ketogenic diet in Energy Metabolism, sponsored by University of Pisa. Completed at 1 site in Italy. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-04.

Sponsored by University of Pisa · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Jun 2022, registered Jan 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Energy Metabolism
03

In context

Lead sponsor

University of Pisa is the lead sponsor of 111 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • overweight and obesity

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    very low ketogenic diet

    patients with overweight and obesity in treatment for weight loss

    Dietary Supplement: very low ketogenic diet

Interventions

  • Dietary supplementvery low ketogenic diet

    1 month of active phase of very low ketogenic diet

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month

07

Study locations

1 site
  • University Hospital of Pisa, Endocrinology Unit
    Pisa, 56124, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06252077
Lead sponsor
University of Pisa
Responsible party
Alessio Basolo (Researcher, PhD, MD, University of Pisa) — Principal investigator
First posted
Feb 9, 2024
Start date
Jun 16, 2022
Primary completion
Jan 16, 2024
Completion
Mar 16, 2025
Last update
Jun 4, 2025

Study contacts

Ferruccio Santini, MD
principal investigator · University of Pisa

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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