NCT04259632Completed
Prolonged Daily Fasting as a Viable Alternative to Caloric Restriction in At-Risk Obese Humans
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 115 (actual)
- First submitted
- 4 Feb 2020
- Start date
- 15 Oct 2020
- Primary completion date
- 12 Oct 2023
- Lead sponsor
- University of Minnesota
- Diseases
- Obesity
- NCT number
- NCT04259632
What you commit to
- Study type: Interventional
- Participants enrolled: 115
- From 15 Oct 2020 to the primary completion date, 12 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of beta-blockers or medications known to affect weight, such as thiazolidinedione (TZD), insulin, glucagon-like peptide (GLP)-1 agonists, phentermine, or sibutamine
Other illness
- Clinically significant medical issues (diabetes, cardiovascular disease, uncontrolled pulmonary disease)
- Concern for active eating disorder per screening questionnaire
- Self-reported eating disorder or history of eating disorder
Lab values
- A history of abnormal laboratory results, such as hematologic (platelets \< 100), hepatic (LFTs \> 2X nl), renal (Cr \> 1.5)
Other
- Shift work (i.e. working from 11pm to 7am)
- MRI contraindication (metal in body, claustrophobia)
- Eating window \< 12 hours per day
- Unable to consistently document food intake using the mCC app (need at least 2 eating occasions\> 6 hours apart on a given day for at least 50% of days)
- Pregnancy
- Illiteracy
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
Related publications
- Post-intervention sustainability of time-restricted eating versus caloric restriction: a secondary analysis.Int J Obes (Lond) · 2026 · PMID 41315749
This page is information, not medical advice. Discuss any trial with your doctor.