Ketogenic Diets for Weight Loss Maintenance: Impact on Energy Expenditure and Appetite in Individuals With Obesity
KETOWEI
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Aug 2025
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2024
CompletedFirst Posted
Study publicly available on registry
December 16, 2024
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
December 18, 2025
December 1, 2025
11 months
December 10, 2024
December 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline total energy expenditure
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
Baseline, week 6, week 10
Secondary Outcomes (16)
Change in appetite ratings
Baseline, week 6, week 10
Change in total body composition
Baseline, week 4, week 6, week 10
Change in total body composition
Baseline, week 4, week 6, week10
Change in fasting insulin
Baseline, week 6, week 10
Change in fasting cholecystokinin
Baseline, week 6, week 10
- +11 more secondary outcomes
Other Outcomes (8)
Blood work: beta hydroxybutyrate
Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
Urine sample: acetoacetate
Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
Change in glucose
Baseline, week 6, week 10
- +5 more other outcomes
Study Arms (2)
Ketogenic Diet
EXPERIMENTALParticipants 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.
Low-Fat Diet
ACTIVE COMPARATORParticipants 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.
Interventions
Participants will be provided food to meet the ketogenic diet prescription for the 6-week weight maintenance phase.
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 10, 2024
First Posted
December 16, 2024
Study Start
August 1, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The data will be shared with others by the time the related study is published and will stay available for at least 10 years.
- Access Criteria
- All datasets that can be shared will be deposited in the NIH-supported Vivli repository which specializes in clinical trial data. Given the sensitive nature of the dataset, de-identified human subjects' data will be made available in Vivli, which restricts access to the data to qualified investigators with an appropriate research question who sign a data use agreement.
This project will produce demographic information, anthropometric and body composition data, energy expenditure, fat oxidation, plasma concentrations of several gastrointestinal hormones involved in appetite regulation, insulin, glucose, blood lipids, and subjective appetite feelings. Data will be obtained from bioimpedance analysis and dual-energy x-ray absorptiometry (DEXA) for body compsoiiton; ELISA, RIA and other laboratorial methods used for the quantification of hormones and metabolites, and questionnaires and visual analogue scales. Data will be collected from 20 research participants. We estimate to be generating gigabyte (.csv) amounts of data. The methodology, statistical analysis plan, and a data dictionary will also be shared. Based on ethical considerations, scientific data will be de-identified and shared at the participant level. Data will be made available in .csv format and will not require the use of specialized tools to be accessed or manipulated.