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The purpose of this study is to investigate the effect of engaging in time restricted eating schedule on body weight, blood glucose, and ketones (breath acetone) in individuals with obesity.
There are significant metabolic and weight reduction benefits associated with time restricted feeding/eating. Time restricted eating splits the day into a period of regeneration (non-eating or natural fasting) and a period of nourishing. Providing the body a period of regeneration allows the body to go into ketosis, or the elevation in circulating ketone bodies, a byproduct of fat metabolism. Breath acetone concentration is a good predictor of ketosis and loss of body fat. In healthy individuals, low concentrations of breath acetone are 1 to 2 ppm. Engaging in weight loss via nutritional ketosis (engaging in high-fat, low-carbohydrate diets, caloric restriction diets, or fasting) increases fat utilization, resulting in increased formation of ketone bodies and breath acetone concentrations ranging from 4 to 30 ppm. In individuals with obesity, nutritional ketosis facilitates weight loss and improves insulin sensitivity, lipid profile, and reduces inflammatory markers.
This study will investigate the effect of participating in two different time restricted eating schedules for 8 weeks on body weight, blood glucose, and ketones.
After being informed about the study and potential risks, all eligible participants giving written informed consent will be randomized to a different time restricted eating schedule (ie, one group fasts for a longer period of time). In both of these groups, fasting will begin each evening and end the following morning.
This is a remote study. All procedures will be conducted at home.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comparator | Active Comparator | Time restricted eating |
|
| Intervention | Experimental | Time restricted eating |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14:10 Regimen | Behavioral | 14 hours of fasting, followed by a 10-h diet regimen that includes a fasting snack at 12 hours from the start of the fasting period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Change from baseline body weight in the intervention group | Week 4 |
| Change in ketone levels (breath acetone) | Change from baseline in breath acetone in the intervention group | Week 8 |
| Change in blood glucose | Change from baseline in blood glucose in the intervention group | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Change from baseline body weight in the intervention group | Week 8 |
| Difference in weight loss between groups | Difference in the change from baseline in body weight between the intervention and control groups |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between weight loss and change in ketone levels (breath acetone) | Correlation between the change from baseline in breath acetone and the change from baseline in body weight | Week 8 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Peeke, MD | Jenny Craig, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jenny Craig | Carlsbad | California | 92008 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40500316 | Derived | Rebello CJ, Zhang D, Anderson JC, Bowman RF, Peeke PM, Greenway FL. Randomized controlled trial of time-restricted eating: secondary analyses of breath acetone. Int J Obes (Lond). 2025 Jul;49(7):1416-1418. doi: 10.1038/s41366-025-01818-1. Epub 2025 Jun 11. |
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Anonymized dataset of selected variables that underlie results in a publication. Some data may not be amenable to complete anonymization and will not be shared to ensure appropriate confidentiality of participant's data.
beginning 6 months after publication
Upon appropriate data request by other scientists
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| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| D001835 | Body Weight |
| D015431 | Weight Loss |
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| 12:12 Regimen | Behavioral | 12 hours of fasting, followed by a 12-h diet regimen |
|
| Weeks 4 and 8 |
| Time to first meal | Change from baseline in the length of time from consumption of the fasting snack until initiation of the first meal in the intervention group | Weeks 4 and 8 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |