Ketogenic Diets for Weight Loss Maintenance: Impact on Energy Expenditure and Appetite in Individuals With Obesity
Purpose
The goal of this clinical trial is to investigate whether a Ketogenic Diet (KD) can increase Total Energy Expenditure (TEE), while benefiting appetite, during weight loss maintenance in reduced-obese individuals.
Condition
- Obesity
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- BMI 30-45 kg/m2 - Both men and women - Age between 18-65 years - Sedentary to moderately active (<2 h/wk of moderate, structured, intentional, exercise)
Exclusion Criteria
- Pregnancy or lactation - 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%
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Active Comparator 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. |
|
Recruiting Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
Birmingham, Alabama 35294
More Details
- Status
- Recruiting
- Sponsor
- University of Alabama at Birmingham
Detailed Description
The total duration of the intervention will be 10 weeks. Participants will first undergo 4 weeks of a low-energy diet (LED), aiming to induce a minimum of 5% weight loss (weight loss phase). Those who achieve at least a 5% weight loss will then be randomized (1:1) to a 6-week weight loss maintenance (WLM) diet, either a KD or an isocaloric low-fat diet, with the first 2 weeks being a gradual refeeding.