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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

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Conditions

Obesity

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States