Ketogenic Diets for Weight Loss Maintenance: Impact on Energy Expenditure and Appetite in Individuals With Obesity
NCT ID: NCT06736028
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-08-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ketogenic Diet
Participants randomized to the ketogenic diet will follow a diet with 5% energy from carbohydrates, 70% from fat, and 25% from protein for 6 weeks. The first 2 of the 6 weeks weeks will be a gradual refeeding, with participants slowly withdrawing from the meal replacements used during the 4-week weight loss phase, while introducing more food.
Diet Therapy
Participants will be provided food to meet the ketogenic diet prescription for the 6-week weight maintenance phase.
Calorie Restriction
Participants will follow a commercial low-energy diet and be provided with meal replacements for 4 weeks aiming to achieve a minimum of 5% weight loss.
Behavioral Support
Participants will meet weekly with a registered dietitian, for a 20-minute consultation throughout the entire study period (10 weeks) to increase engagement and improve adherence and retention.
Low-Fat Diet
Participants randomized to the low-fat diet will follow a diet with 50% energy from carbohydrates, 25% energy from fat, and 25% energy from protein for 6 weeks. The first 2 of the 6 weeks weeks will be a gradual refeeding, with participants slowly withdrawing from the meal replacements used during the 4-week weight loss phase, while introducing more food.
Calorie Restriction
Participants will follow a commercial low-energy diet and be provided with meal replacements for 4 weeks aiming to achieve a minimum of 5% weight loss.
Behavioral Support
Participants will meet weekly with a registered dietitian, for a 20-minute consultation throughout the entire study period (10 weeks) to increase engagement and improve adherence and retention.
Diet Therapy
Participants will have food provided to meet the standard low-fat diet prescription for the 6-week weight maintenance phase.
Interventions
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Diet Therapy
Participants will be provided food to meet the ketogenic diet prescription for the 6-week weight maintenance phase.
Calorie Restriction
Participants will follow a commercial low-energy diet and be provided with meal replacements for 4 weeks aiming to achieve a minimum of 5% weight loss.
Behavioral Support
Participants will meet weekly with a registered dietitian, for a 20-minute consultation throughout the entire study period (10 weeks) to increase engagement and improve adherence and retention.
Diet Therapy
Participants will have food provided to meet the standard low-fat diet prescription for the 6-week weight maintenance phase.
Eligibility Criteria
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Inclusion Criteria
* Both men and women
* Age between 18-65 years
* Sedentary to moderately active (\<2 h/wk of moderate, structured, intentional, exercise)
Exclusion Criteria
* Daily use of tobacco (\>1 pk/wk)
* Change in weight greater than 5 lb in the previous 3 months
* Cognitive impairment
* Previous bariatric surgery
* History of eating disorder
* Presence of any condition (e.g. DM2, PCOS, inflammatory disease, untreated thyroid disease, fluid overload states such as chronic kidney disease, congestive heart failure, or cirrhosis)
* Use of any medication (e.g., glucocorticoid, GLP-1 analogues, hormone replacement therapy) deemed to interfere with study outcomes.
* Pre-menopausal women will need to have a regular menstrual cycle (28+/-2 days) or be on hormonal contraceptives
* Fasting glucose plasma concentration \>125 mg/dl and/or HbA1c \> 6.4%
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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Catia Martins
Associate Professor
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Catia Martins, PhD
Role: primary
Other Identifiers
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IRB-300012956
Identifier Type: -
Identifier Source: org_study_id