N/A
N=88
Prolonged Daily Fasting as a Viable Alternative to Caloric Restriction in At-Risk Obese Humans
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04259632 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Change in Weight — -3; -3.5; -1.3 Kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Time Restricted Eating (TRE) (Behavioral); Caloric Restriction (CR) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight |
-3; -3.5; -1.3 | — |
| SECONDARY Change in Whole Body Percent Fat |
— | — |
| SECONDARY Change in Visceral Fat |
— | — |
| SECONDARY Change in Lean Mass |
— | — |
| SECONDARY Change in Fat Mass |
— | — |
| SECONDARY Change in Caloric Intake |
— | — |
| SECONDARY Change in Metabolic Flexibility |
— | — |
Summary
Purpose: Obesity is reaching epidemic proportions, affecting 36% of the adult population in the United States. There is intense interest in dietary management to treat obesity and its associated complications. The first line of obesity treatment is caloric restriction (CR), although recidivism is common. For moderate CR, attrition rates of 20% are often reported, therefore weight loss options beyond CR are urgently needed.
Eligibility Criteria
Inclusion Criteria
- BMI ≥30 and ≤ 55 kg/m^2
- Own a smartphone compatible with the myCircadianClock (mCC) phone application
- Self-reported habitual wakening between 5-9 am
- Self reported sleep duration of 6-9 hours
- Weight must be stable [+/- 5 pounds] for at least 3 months prior to the study
- Eating window (time between 1st food intake and last food take) ≥14 hours using mCC
- Insulin resistance based on HOMA-IR≥ 2.5 from screening visit results
- Able to understand English
Exclusion Criteria
- Use of beta-blockers or medications known to affect weight, such as thiazolidinedione (TZD), insulin, glucagon-like peptide (GLP)-1 agonists, phentermine, or sibutamine
- Shift work (i.e. working from 11pm to 7am)
- Clinically significant medical issues (diabetes, cardiovascular disease, uncontrolled pulmonary disease)
- A history of abnormal laboratory results, such as hematologic (platelets 2X nl), renal (Cr > 1.5)
- MRI contraindication (metal in body, claustrophobia)
- Eating window 6 hours apart on a given day for at least 50% of days)
- Pregnancy
- Illiteracy
- Concern for active eating disorder per screening questionnaire
- Self-reported eating disorder or history of eating disorder
Data sourced from ClinicalTrials.gov (NCT04259632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.