← Back to Search

Prolonged Daily Fasting for Obesity

N/A
Waitlist Available
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks
Awards & highlights

Study Summary

This trial is testing a new weight loss drug that may help people who are obese lose weight and keep it off.

Who is the study for?
This trial is for adults with obesity (BMI between 30 and 55) who have had a stable weight for the past three months, use a smartphone, wake up early, get average sleep, and have an eating window of over 14 hours. It's not for shift workers, pregnant individuals, those with certain medical conditions or abnormal lab results, history of eating disorders or using specific medications.Check my eligibility
What is being tested?
The study is testing if prolonged daily fasting can be as effective as traditional calorie cutting in helping obese people manage their weight. Participants will either follow Time Restricted Eating (TRE) where they eat during limited hours or Caloric Restriction (CR), reducing overall food intake.See study design
What are the potential side effects?
Potential side effects may include hunger pangs, mood changes like irritability due to hunger or change in diet pattern. Long-term effects are unknown but could involve nutritional deficiencies if not properly managed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Weight
Secondary outcome measures
Change in Caloric Intake
Change in Fat Mass
Change in Lean Mass
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Time Restricted Eating (TRE)Experimental Treatment1 Intervention
For the TRE group, we will restrict the eating window to 8 hours, where they will eat ad libitum. This is the same interval established by Dr. Panda and by our preliminary data. This interval will be entered into the mCC app and participants will be asked to adhere to this eating window during the intervention. All eating occasions will be logged using the mCC app. Only water and medications will be allowed outside of the eating window.
Group II: Caloric Restriction (CR)Active Control1 Intervention
Participants randomized to CR will meet with the study dietitian prior to the intervention and be counseled on options to reduce their caloric intake by 15%, while maintaining their eating window. The 15% reduction was selected as our preliminary data and recent literature suggest that TRE with ad libitum intake reduces caloric intake by ~270 to 300 cal/day. The 15% CR is similar to the 11.9% CR achieved by the CALERIE-2 study, which is a 2 year study of CR.26 All eating occasions will be logged using the mCC app. The weekly dietitian review of the mCC information will include maintenance of the eating window and examination of dietary intake to determine compliance with the 15% CR.
Group III: Unrestricted Eating (non-TRE)Active Control1 Intervention
For the unrestricted eating (non-TRE) group, participants will eat ad libitum per their usual habits. They will receive initial counseling about mCC logging. All eating occasions will be logged using the mCC app.

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,379 Previous Clinical Trials
1,588,406 Total Patients Enrolled
69 Trials studying Obesity
20,659 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,151 Total Patients Enrolled
446 Trials studying Obesity
588,848 Patients Enrolled for Obesity

Media Library

Caloric Restriction Clinical Trial Eligibility Overview. Trial Name: NCT04259632 — N/A
Obesity Research Study Groups: Time Restricted Eating (TRE), Caloric Restriction (CR), Unrestricted Eating (non-TRE)
Obesity Clinical Trial 2023: Caloric Restriction Highlights & Side Effects. Trial Name: NCT04259632 — N/A
Caloric Restriction 2023 Treatment Timeline for Medical Study. Trial Name: NCT04259632 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are included in this medical experiment?

"Yes, the information hosted at clinicaltrials.gov shows that this investigation is actively seeking participants. This trial was first posted on October 15th 2020 and most recently updated August 8th 2022; it needs 90 individuals from a single site to complete its objectives."

Answered by AI

Are any openings available for participation in the trial?

"Affirmative. According to clinicaltrials.gov, this medical experiment was initially posted on October 15th 2020 and is now seeking participants. At the moment 90 candidates are needed from a single trial site."

Answered by AI

What are the criteria for admission into this research project?

"This medical trial requires 90 volunteers of ages 18-65 with obesity, who meet the criteria for BMI (30-55 kg/m^2), habitual wakening times between 5am and 9am, sleep duration 6-9 hours, insulin resistance HOMA-IR≥ 2.5 from screening visit results, English comprehension capacity, ownership of a smartphone compatible with myCircadianClock application and an eating window ≥14 hours recorded by mCC app as well as weight stability over 3 months prior to study initiation."

Answered by AI

Are elderly participants welcome to join this trial?

"This trial adheres to stringent age restrictions, not permitting any participants who are under 18 years old or over 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Prolonged Daily Fasting as a Viable Alternative to Caloric Restriction in At-Risk Obese Humans
2020. "Prolonged Daily Fasting as a Viable Alternative to Caloric Restriction in At-Risk Obese Humans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04259632.
~27 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top