NCT06736028NARecruiting
Ketogenic Diets for Weight Loss Maintenance: Impact on Energy Expenditure and Appetite in Individuals With Obesity
University of Alabama at Birmingham
Start Date
8/1/2025
Completion Date
3/30/2027
Summary
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.
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.
Eligibility Criteria
Age Range: 18 years to 65 years
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%
Interventions
BEHAVIORAL
Diet Therapy
BEHAVIORAL
Calorie Restriction
BEHAVIORAL
Behavioral Support
BEHAVIORAL
Diet Therapy
Conditions
Obesity
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States