Ketogenic Diet Study for Keeping Weight Off in Adults With Obesity
Tests whether a ketogenic diet affects energy use and appetite in adults with obesity.
Key facts
- Who runs it
- University of Alabama at Birmingham
- Where
- Birmingham, United StatesSee the site
- Trial code
- Registry title
- Ketogenic Diets for Weight Loss Maintenance: Impact on Energy Expenditure and Appetite in Individuals With Obesity
- Status
- Recruiting
- People taking part
- 20 people, planned
- Started
- 1 Aug 2025
- Expected to end
- 30 Mar 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Diet Therapy
- Calorie Restriction
- Behavioral Support
- Record updated
- 7 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with obesity who do little or moderate exercise. It studies whether a ketogenic diet changes energy use and appetite while keeping off lost weight.
- Age
- 18 to 65 years
- Sex
- Men and women can join
- Disease stage
- Obesity with a BMI of 30-45 kg/m2
- Earlier treatment
- Weight must not have changed by more than 5 lb (2 kg) in the previous 3 months. People with previous bariatric surgery cannot join.
- Biomarker or test result
- Fasting glucose must not be above 125 mg/dl (6.9 mmol/L) and HbA1c must not be above 6.4% (46 mmol/mol).
Main reasons for not taking part
- Pregnancy or breastfeeding
- Previous bariatric surgery
- History of eating disorder
- Conditions such as DM2, PCOS, inflammatory disease, untreated thyroid disease, chronic kidney disease, congestive heart failure or cirrhosis
- Use of medicines that may interfere with study results, such as glucocorticoids or GLP-1 analogues
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Change in weight greater than 5 lb in the previous 3 months
- Previous bariatric surgery
- Use of any medication (e.g., glucocorticoid, GLP-1 analogues, hormone replacement therapy) deemed to interfere with study outcomes
- Cognitive impairment
- 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)
- Fasting glucose plasma concentration >125 mg/dl and/or HbA1c > 6.4%
- Pregnancy or lactation
- Daily use of tobacco (>1 pk/wk)
- Pre-menopausal women will need to have a regular menstrual cycle (28+/-2 days) or be on hormonal contraceptives
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in United States
- University of Alabama at BirminghamBirmingham, United StatesContact: Catia Martins, PhDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Ketogenic DietTreatment being tested
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: Diet Therapy, Calorie Restriction, and Behavioral Support
- Low-Fat DietExisting treatment, for comparison
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: Calorie Restriction, Behavioral Support, and Diet Therapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Ketogenic Diets for Weight Loss Maintenance: Impact on Energy Expenditure and Appetite in Individuals With Obesity
- Plain-language title
- Ketogenic Diet Study for Keeping Weight Off in Adults With ObesityGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06736028, who can take part
- Record updated
- 7 April 2026