Prolonged Daily Fasting as a Viable Alternative to Caloric Restriction in At-Risk Obese Humans

Completed · Not applicable

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT04259632

Run by

University of Minnesota

People needed

115

Starts

2020-10-15

Expected to finish

2025-12-31

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 < 100), hepatic (LFTs > 2X nl), renal (Cr > 1.5)
• 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
• Concern for active eating disorder per screening questionnaire
• Self-reported eating disorder or history of eating disorder

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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