Clinical trial NCT06736028: Ketogenic Diets for Weight Loss Maintenance: Impact on Energy Expenditure and Appetite in Individuals With Obesity
Official title: Ketogenic Diets for Weight Loss Maintenance: Impact on Energy Expenditure and Appetite in Individuals With Obesity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Ketogenic Diet
Weight loss
Weight loss maintenance
Appetite
Energy expenditure
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-12-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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). This will then be followed by a 2-week refeeding and weight stabilization phase and those achieving a weight loss of at least 5% of baseline weight by the end of week 6, will then be randomized (1:1) to undergo a 4-week weight loss maintenance (WLM) phase with either a KD or an isocaloric low-fat diet.

Eligibility 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%

Primary outcomes:
measure: Change from baseline total energy expenditure
timeFrame: Baseline, week 6, week 10
Secondary outcomes:
measure: Change in appetite ratings
timeFrame: Baseline, week 6, week 10
measure: Change in total body composition
timeFrame: Baseline, week 4, week 6, week 10
measure: Change in total body composition
timeFrame: Baseline, week 4, week 6, week10
measure: Change in fasting insulin
timeFrame: Baseline, week 6, week 10
measure: Change in fasting cholecystokinin
timeFrame: Baseline, week 6, week 10
measure: Change in fasting ghrelin
timeFrame: Baseline, week 6, week 10
measure: Change in fasting glucagon-like peptide-1
timeFrame: Baseline, week 6, week 10
measure: Change in fasting peptide yy
timeFrame: Baseline, week 6, week 10
measure: Change in total body weight
timeFrame: Baseline, week 4, week 6, week 10
measure: Change in mechanical efficiency
timeFrame: Baseline, week 6, week 10
measure: Change in resting energy expenditure
timeFrame: Baseline, week 6, week 10
measure: Change in postprandial insulin
timeFrame: Baseline, week 6, week 10
measure: Change in postprandial cholecystokinin
timeFrame: Baseline, week 6, week 10
measure: Change in postprandial ghrelin
timeFrame: Baseline, week 6, week 10
measure: Change in postprandial glucagon-like peptide-1
timeFrame: Baseline, week 6, week 10
measure: Change in postprandial peptide yy
timeFrame: Baseline, week 6, week 10
Other outcomes:
measure: Blood work: beta hydroxybutyrate
timeFrame: Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
measure: Urine sample: acetoacetate
timeFrame: Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
measure: Change in glucose
timeFrame: Baseline, week 6, week 10
measure: Change in total cholesterol
timeFrame: Baseline, week 6, week 10
measure: Change in high-density lipoprotein cholesterol
timeFrame: Baseline, week 6, week 10
measure: Change in triglycerides
timeFrame: Baseline, week 6, week 10
measure: Change in free fatty acids
timeFrame: Baseline, week 6, week 10
measure: Change in average appetite
timeFrame: Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: