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

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Obesity

Treatments: Behavioral: Calorie Restriction; Behavioral: Behavioral Support; Behavioral: Diet Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06736028

IRB-300012956

P30DK079626 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Ketogenic Diet

Experimental group

Description:

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.

Treatment:

Behavioral: Diet Therapy

Behavioral: Behavioral Support

Behavioral: Calorie Restriction

Behavioral: Diet Therapy

Low-Fat Diet

Active Comparator group

Description:

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.

Treatment:

Behavioral: Diet Therapy

Behavioral: Behavioral Support

Behavioral: Calorie Restriction

Behavioral: Diet Therapy