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Comparison of Weight Loss Induced by Intermittent Fasting Versus Daily Caloric Restriction in Individuals with Obesity: A 1-Year Randomized Trial

Study category: Diabetes & Hormone Disorders

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Description

This study plans to learn more about the best eating patterns for weight loss. Specifically, this study is being done to try to determine if intermittent fasting is as effective for weight loss as daily calorie restriction. In this study, we will be evaluating how your body weight, body composition, laboratory values, energy expenditure, and eating and exercise behaviors change during a 12-month weight loss program. We will also evaluate how your biology, life experiences, thought processes, behaviors, and environment predict how much weight you lose and how well you follow the diet and exercise recommendations in the study.

Details
Age

Adult

Eligibility

Female or Male Age 18-65 years Body Mass Index 27-46 kg/m2 Sedentary: defined as <150 minutes per week of voluntary exercise at moderate intensity or greater and < 60 min per day of total habitual physical activity (i.e. work related, transportation related) at moderate intensity or greater, over the past 3 months. No self-report of acute or chronic disease No plans to relocate within the next 12 months No plans for extended travel (> 2 weeks) within the next 12 months No nicotine use For Females: -Not currently pregnant or lactating -Not pregnant within the past 6 months -Not planning to become pregnant in the next 12 months

Detailed Eligibility: Inclusion Criteria: Female or Male; Age 18-65 years; BMI 27-46 kg/m2; Sedentary: <150 minutes per week of voluntary exercise at moderate intensity or greater and < 60 min per day of total habitual physical activity at moderate intensity or greater, over the past 3 months; No self-report of acute or chronic disease; No plans to relocate within the next 12 months; No plans for extended travel (> 2 weeks) within the next 12 months; No nicotine use; Live or work within 30 minutes of the AHWC; Capable and willing to give informed consent, understand exclusion criteria, and accept the randomized group assignment; Have a PCP (or are willing to establish care with a primary care physician prior to study enrollment); For Females: Not pregnant or lactating, not pregnant within the past 6 months, not planning to become pregnant in the next 12 months. Exclusion Criteria Diastolic blood pressure > 100 mm HG or systolic blood pressure > 160 mm HG; Resting heart rate >100; Diabetes; Undiagnosed hypo- or hyper-thyroidism or history of uncontrolled thyroid disorder; Hematocrit, white blood cell count or platelets significantly outside the normal reference range; Triglycerides > 400 mg/d; LDL cholesterol > 190 mg/dL; Abnormal resting electrocardiogram; 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, significant GI disorders, significant pulmonary disorders, significant renal, musculoskeletal, neurologic, hematologic, or psychiatric disease; Significant GI disorders; Significant pulmonary disorders including: 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; Regular use of prescription or over-the-counter medications known to significantly impact appetite, weight, or energy metabolism; Regular use of systemic steroids (other than Oral Contraceptive Pills); Regular use of obesity pharmacotherapeutic agents within the last 6 months; 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; Current alcohol or substance abuse; Nicotine use (past 6 months); History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder; Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode; History of other significant psychiatric illness which in the opinion of the Study MD would interfere with ability to adhere to dietary or exercise interventions; Currently participating in or planning to participate in any formal weight loss or physical activity programs or clinical trials; Participation in a weight loss program using the Colorado Weigh curriculum within the past 3 years; Currently following an IMF weight loss diet plan; Weight loss >5kg in past 3 months for any reason except post-partum weight loss, weight gain >5kg in past 3 months

Type of Study

Outcomes Research

Locations

Anschutz Health and Wellness
UCD Anschutz Health & Wellness Center
University of Colorado Hospital

Principal Investigator
Vicki Catenacci,  MD

Vicki Catenacci, MD

Study ID

Protocol Number: 17-0369

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