The Effects of Continuous vs. Intermittent Caloric Restriction on Fat Los

Study Overview
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Brief Summary
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The purpose of this research study examines fat mass loss using a continuous calorie reduction protocol versus continuous caloric restriction interspersed with diet refeeds and diet breaks over 12 weeks.

Detailed Description
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In order to lose weight, an individual must sustain an energy deficit (whereby caloric intake is significantly lower than expenditure) over time. However, a rich base of evidence suggests that weight loss often results in a decreased metabolic rate. This decrease, likely the result of a number of physiological and behavioral mechanisms, makes the continuation of weight loss more difficult as well as increases the likelihood of weight regain, or the rebound effect (1, 2). One proposed method of promoting the retention of a higher metabolic rate through a period of caloric restriction, and therefore preventing the regain of excess weight after energy restriction is discontinued, is the use of intermittent rather than continuous caloric restriction. Intermittent energy restriction (IER) involves undulating one's energy intake throughout a dieting period as opposed to sustaining a continuous energy deficit. Research in overweight and obese individuals has shown that periods of moderate caloric restriction interspersed with periods of consuming a diet in balance with one's daily energy needs (caloric maintenance) is at least comparable to continuous energy restriction in terms of weight and fat loss outcomes (3) and may even bestow unique benefits by promoting greater retention of fat-free mass and a higher metabolic rate (4). However, to date, no published research has examined continuous caloric restriction compared to Intermittent energy restriction (diet breaks and diet refeeds) in females only with Obesity.

Official Title
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The Effects of Continuous vs. Intermittent Caloric Restriction on Fat Loss: A Randomized Controlled Trial

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Continuous Caloric Restriction versus Intermittent Caloric Restriction on Fat Loss


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 18-65 years of age, 2) Females only, 3) All ethnicities 4). Must reside in Horry County, South Carolina, 5) have a BMI of > 30-45 kg/m2 6) weight stable for the last 3 months 7). Exercise less than 150 minutes of physical activity per week) 8. Have access to an Apple® iPhone or Android® smart phone. Exclusion Criteria: Adults who are physically active greater than 150 minutes per week, participants who were unwilling or unable to attend testing sessions between 6 am and 12 pm, participants planning to take holidays and/or work-related travel during the study period (challenges adherence to the diet, and interferes with testing session scheduling, participants who have lost greater than 10 pounds in the last 3 months, participants has stated an immunodeficiency disorder, kidney disease, heart attack within the last 3 months, has known dementia, brain cancer, current eating disorders, history of significant neurological or psychiatric disorder or any other psychological condition impacting their decision making, currently taking dietary supplements that could profoundly modify metabolism or body weight, has undergone major surgery, less than 4 weeks prior to enrollment in the study, undergone bariatric surgery <12 months prior to starting the study, or diagnosis of type 1 diabetes. Although not anticipated for this study population, women cannot be or suspect they may be pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: All participants were randomized in a balanced fashion and stratified by body fat percentage into either one of the two intervention groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Caloric Restriction (CCR) group:<br>Participants in this group will be placed on a diet that is prescribed a 25% reduction from maintenance calories (calories to maintain current body weight) with a dietary protein intake of 1.2 g of protein/kg body mass and remaining calories split evenly between fat and carbohydrate. In this group they will adhere to a 25% caloric reduction daily for 12 weeks. | Behavioral: Continuous Caloric Restriction versus Intermittent Caloric Restriction on Fat Loss<br>* This intervention seeks to investigate two different caloric restriction protocol on fat mass.<br>|
| Experimental: Intermittent Caloric Restriction (ICR) group:<br>Participants in this group will be placed on a diet that is prescribed a 25% reduction from maintenance calories (calories to maintain current body weight) with a dietary protein intake of 1.2 g of protein/kg body mass and remaining calories split evenly between fat and carbohydrate. Participants will adhere to a 25% caloric deficit daily and on every 7th day they will eat their maintenance calories known as a diet refeed and then on the 3rd week they will take a diet break of eating their Maintenance calories for 7 days. | Behavioral: Continuous Caloric Restriction versus Intermittent Caloric Restriction on Fat Loss<br>* This intervention seeks to investigate two different caloric restriction protocol on fat mass.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat Loss | Investigators examined body composition fat loss between groups baseline (week 0) and post intervention (week 12). | Change in fat mass between baseline (week 0) and post intervention (week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Weight Loss | Investigators examined % body weight loss between groups baseline (week 0) and post intervention (week 12). | Change in % weightloss between baseline (week 0) and post intervention (week 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Loss, Telehealth, health Coaching, Diet Breaks