Early vs. Late Time Restricted Eating vs. Daily Caloric Restriction

NCT05870982 | Active Not Recruiting

• 2 other identifiers: 22-1829R01DK132372
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about time restricted eating as a weight loss intervention in adults with obesity. The main questions it aims to answer are:

1. 1.How does the timing of the eating window (early vs late time restricted eating) affect weight loss and changes in metabolic risk factors?
2. 2.How does time restricted eating compare to standard of care (daily caloric restriction) for weight loss and changes in metabolic risk factors?
3. 3.They will be asked to follow the assigned dietary strategy for 1 year and will receive a group-based program for instruction and support.
4. 4.They will be asked at several times during the year to have their weight and body composition measured, provide blood samples, track their food, and wear monitors for physical activity and sleep.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Body weight (kg)

  Body weight will be measured using a digital scale at baseline, weeks 14, 26 and 52. The primary outcome will be change in weight from baseline to 26 weeks.

  0 to 52 weeks

Secondary Outcomes (12)

• Fat mass

  0 to 52 weeks

• Lean mass

  0-52 weeks

• Blood pressure

  0-52 weeks

• HbA1c

  0-52 weeks

• Insulin sensitivity

  0-52 weeks

Study Arms (3)

Early time restricted eating

EXPERIMENTAL

Participants will asked to follow early time restricted eating

Behavioral: Early TRE

Late time restricted eating

EXPERIMENTAL

Participants will be asked to follow late time restricted eating

Behavioral: Late TRE

Daily caloric restriction

ACTIVE COMPARATOR

Participants will be instructed to follow daily caloric restriction

Behavioral: DCR

Interventions

Early TRE BEHAVIORAL

Participants will be instructed to eat only during an 8-hour window starting 1-2 hours after waking.

Early time restricted eating

Late TRE BEHAVIORAL

Participants will be instructed to eat only during an 8-hour window starting 5-6 hours after waking.

Late time restricted eating

DCR BEHAVIORAL

Participants will be instructed to reduce caloric intake by 25%.

Daily caloric restriction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males and females with a BMI of 27-45 kg/m2
• Age, 18-65 years old
• Passing medical and physical screening, and analysis of blood and urine screening samples
• Individuals who are not currently following an intermittent fasting or TRE dietary regimen (i.e., eating across less than a 10-hour period during the day).
• Own a smartphone
• Live or work within 45 minutes of the Anschutz Health \& Wellness Center (exceptions may be made at the discretion of the Study PI on a case-by-case basis for highly motivated subjects)
• No plans to relocate within the next 12 months

You may not qualify if:

• Have a primary care physician (or are willing to establish care with a primary care physician prior to study enrollment) to address medical issues which may arise during screening or study procedures/interventions.
• Pregnancy or lactation for women (women who are \>6 months postpartum with no plans of becoming pregnant in the next year and who are not currently lactating can be included; oral contraceptives will be allowed if medication has been consistent for the prior 6 months)
• Weight loss \>5kg in past 3 months for any reason except post-partum weight loss, weight gain \>5kg in past 3 months requires assessment by PI to determine reason for weight gain and if it is appropriate for the subject to participate in the study
• Weight loss of \>50 lbs in past 3 years for any reason except post-partum weight loss
• Presence or history of any metabolic or chronic health problems which would affect appetite, food intake, energy metabolism, or ability to optimally participate in the exercise component including: CVD, peripheral vascular disease, cerebrovascular disease, significant cardiac arrhythmias or cardiac valve disease, diabetes, uncontrolled hyper- or hypothyroidism, uncontrolled hypertension, cancer (within the last 5 years, except skin cancer or other cancers considered cured with excellent prognosis), HIV infection, seizure disorders, significant gastrointestinal disorders (described below), significant pulmonary disorders (described below), significant renal, musculoskeletal, neurologic, hematologic, or psychiatric disease.
• Significant gastrointestinal disorders including: chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, Ulcerative Colitis, chronic diarrhea, or active gallbladder disease.
• Significant pulmonary disorders including: chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, or uncontrolled asthma.
• Symptoms suggestive of CVD: chest pain, shortness of breath at rest or with mild exertion, syncope.
• Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician
• Having abnormal blood chemistry (eGFR\<45mL/min, AST or ALT \>3 times the upper limit of normal) or as deemed significant by the study physician
• LDL cholesterol \>200 mg/dL
• Triglycerides \> 500 mg/dL
• Being considered unsafe to participate as determined by the study physician
• Previous obesity treatment with surgery or weight loss device, except: (1) liposuction and/or abdominoplasty if performed \> 1 year before screening, (2) lap banding if the band has been removed \> 1 year before screening, (3) intragastric balloon if the balloon has been removed \> 1 year before screening (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \> 1 year before screening or 5) AspireAssist or other endoscopically placed weight loss device if the device has been removed \> 1 year before screening.
• Being a smoker or having been a smoker in the 3 months prior to their screening visit

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Colorado Anschutz Health and Wellness Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, parallel-arm clinical trial

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 23, 2023
• Study Start: July 11, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)