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

Sponsor
Coastal Carolina University (Other)
Overall Status
Completed
CT.gov ID
NCT06079658
Collaborator
(none)
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Continuous Caloric Restriction versus Intermittent Caloric Restriction on Fat Loss
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
All participants were randomized in a balanced fashion and stratified by body fat percentage into either one of the two intervention groups.All participants were randomized in a balanced fashion and stratified by body fat percentage into either one of the two intervention groups.
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Effects of Continuous vs. Intermittent Caloric Restriction on Fat Loss: A Randomized Controlled Trial
Actual Study Start Date :
Oct 1, 2022
Actual Primary Completion Date :
Aug 15, 2023
Actual Study Completion Date :
Aug 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Continuous Caloric Restriction (CCR) group:

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
This intervention seeks to investigate two different caloric restriction protocol on fat mass.

Experimental: Intermittent Caloric Restriction (ICR) group:

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
This intervention seeks to investigate two different caloric restriction protocol on fat mass.

Outcome Measures

Primary Outcome Measures

  1. Fat Loss [Change in fat mass between baseline (week 0) and post intervention (week 12)]

    Investigators examined body composition fat loss between groups baseline (week 0) and post intervention (week 12).

Secondary Outcome Measures

  1. % Weight Loss [Change in % weightloss between baseline (week 0) and post intervention (week 12)]

    Investigators examined % body weight loss between groups baseline (week 0) and post intervention (week 12).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Williams Brice Building Conway South Carolina United States 29526

Sponsors and Collaborators

  • Coastal Carolina University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kelly Johnson, Assistant Professor Exercise Science, Coastal Carolina University
ClinicalTrials.gov Identifier:
NCT06079658
Other Study ID Numbers:
  • 2023.06
First Posted:
Oct 12, 2023
Last Update Posted:
Oct 12, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kelly Johnson, Assistant Professor Exercise Science, Coastal Carolina University

Study Results

No Results Posted as of Oct 12, 2023