NCT06736028

Ketogenic Diets for Weight Loss Maintenance: Impact on Energy Expenditure and Appetite in Individuals With Obesity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Diet Therapy	Participants will be provided food to meet the ketogenic diet prescription for the 6-week weight maintenance phase.
BEHAVIORAL	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	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.
BEHAVIORAL	Diet Therapy	Participants will have food provided to meet the standard low-fat diet prescription for the 6-week weight maintenance phase.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-12-31
• Completion: 2027-03-30
• First posted: 2024-12-16
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States