Energy Metabolism Clinical Trial
Official title:
Effect of Very Low Ketogenic Diet on Energy Metabolism in Women With Obesity
NCT number | NCT06252077 |
Other study ID # | EECR |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 16, 2022 |
Est. completion date | June 16, 2024 |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | June 16, 2024 |
Est. primary completion date | January 16, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | University Hospital of Pisa, Endocrinology Unit | Pisa |
Lead Sponsor | Collaborator |
---|---|
University of Pisa |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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