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Recruiting NCT06736028

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

No phase Interventional Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diet Therapy, Calorie Restriction, Behavioral Support, Diet Therapy.
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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). 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.

Interventions

  • Behavioral Diet Therapy
    Participants will be provided food to meet the ketogenic diet prescription for the 6-week weight maintenance phase.
  • Behavioral Calorie Restriction
    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 Behavioral Support
    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.
  • Behavioral Diet Therapy
    Participants will have food provided to meet the standard low-fat diet prescription for the 6-week weight maintenance phase.

Primary outcome measures

  • Change from baseline total energy expenditure [Time frame: Baseline, week 6, week 10]
Secondary outcome measures (12)
  • Change in appetite ratings [Time frame: Baseline, week 6, week 10]
  • Change in total body composition [Time frame: Baseline, week 4, week 6, week 10]
  • Change in total body composition [Time frame: Baseline, week 4, week 6, week10]
  • Change in fasting insulin [Time frame: Baseline, week 6, week 10]
  • Change in fasting cholecystokinin [Time frame: Baseline, week 6, week 10]
  • Change in fasting ghrelin [Time frame: Baseline, week 6, week 10]
  • Change in fasting glucagon-like peptide-1 [Time frame: Baseline, week 6, week 10]
  • Change in fasting peptide YY (PYY) [Time frame: Baseline, week 6, week 10]
  • Change in total body weight [Time frame: Baseline, week 4, week 6, week 10]
  • Change in mechanical efficiency [Time frame: Baseline, week 6, week 10]
  • Change in resting energy expenditure [Time frame: Baseline, week 6, week 10]
  • Change in postprandial insulin [Time frame: Baseline, week 6, week 10]

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%

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Alabama at Birmingham — Birmingham

Identifiers

NCT: NCT06736028 · IRB-300012956 · P30DK079626

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗