Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06736028

Recruiting nowNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry criteria

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%

Treatments and study arms

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.

Primary outcomes

Change from baseline total energy expenditureBaseline, week 6, week 10

Total Energy Expenditure (TEE) refers to the total amount of energy (calories) your body uses in a day. Twenty-four-hour EE and RQ will be measured inside the whole room indirect calorimeter (chamber) following standard procedures

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Alabama at Birmingham🇺🇸 Birmingham, Alabama, United States

Open map

Catia Martins, PhDContact

Email · Call 2059347922