NCT06252077

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

January 23, 2024

Last Update Submit

May 28, 2025

Conditions

Energy Metabolism

Outcome Measures

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.

    1 month

Study Arms (1)

very low ketogenic diet

EXPERIMENTAL

patients with overweight and obesity in treatment for weight loss

Dietary Supplement: very low ketogenic diet

Interventions

very low ketogenic dietDIETARY_SUPPLEMENT

1 month of active phase of very low ketogenic diet

very low ketogenic diet

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • overweight and obesity

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Pisa, Endocrinology Unit

Pisa, 56124, Italy

Location

Study Officials

  • Ferruccio Santini, MD

    University of Pisa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: body weight loss
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher, PhD, MD

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 9, 2024

Study Start

June 16, 2022

Primary Completion

January 16, 2024

Study Completion

March 16, 2025

Last Updated

June 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)