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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06736028
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Diet Therapy — BEHAVIORAL
    Participants will be provided food to meet the ketogenic diet prescription for the 6-week weight maintenance phase.
  • Calorie Restriction — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    Participants will have food provided to meet the standard low-fat diet prescription for the 6-week weight maintenance phase.

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Mar 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change from baseline total energy expenditure [ Time Frame: Baseline, week 6, week 10 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Catia Martins, PhD
[email protected]
2059347922

Find similar trials in Birmingham, AL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Alabama at Birmingham· Birmingham, AL

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