Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Ketogenic versus low-fat diets to help keep weight off and change energy use and appetite

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

Run by University of Alabama at Birmingham · NCT06736028 · Data updated 2026-11-12

This tests whether a ketogenic diet versus an isocaloric low-fat diet helps people with obesity keep weight off by increasing daily energy use and reducing appetite.

More Obesity trials

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment20 (estimated)
SponsorUniversity of Alabama at Birmingham
Academic / other
Locations1 site (Birmingham, Alabama)
StatusRecruiting
StartedAugust 1, 2025
Main results expectedDecember 31, 2026
Study endsMarch 30, 2027
Registry record updatedApril 7, 2026
Trial IDNCT06736028 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–65 with BMI 30–45 who can lose at least 5% body weight during a 4-week low-energy diet, are not pregnant or lactating, and do not have medical conditions or medications that affect metabolism.

Probably not a fit

People with diabetes, prior bariatric surgery, untreated thyroid disease, certain inflammatory or organ diseases, pregnant or breastfeeding people, or those taking weight-affecting medications are excluded and would not be expected to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with obesity first complete a 4-week low-energy diet aiming for at least 5% weight loss. Those who achieve the target are randomized 1:1 to six weeks of weight-loss maintenance on either a ketogenic diet or an isocaloric low-fat diet, with the first two weeks as gradual refeeding. Total energy expenditure and measures of appetite are collected during the maintenance phase to determine metabolic and hunger effects of the diets. The intervention duration is 10 weeks and includes behavioral support and calorie guidance.

Why it matters

Potential benefit: If successful, the approach could help people maintain weight loss by increasing daily energy expenditure and reducing appetite, making long-term weight control easier.

How similar studies have gone: Some prior trials show ketogenic diets produce faster early weight loss and can reduce appetite, but clear evidence that ketogenic diets increase total energy expenditure during weight-loss maintenance is limited.

Who can join: the full rules

Show full inclusion / exclusion 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%

Where it's running

  • University of Alabama at Birmingham
    Birmingham, Alabama, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.