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

NCT06079658 | Completed

• 1 other identifier: 2023.06
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Weight Loss, Telehealth, health Coaching, Diet Breaks

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• % Weight Loss

  Change in % weightloss between baseline (week 0) and post intervention (week 12)

Study Arms (2)

Continuous Caloric Restriction (CCR) group:

EXPERIMENTAL

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

Intermittent Caloric Restriction (ICR) group:

EXPERIMENTAL

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

Interventions

Continuous Caloric Restriction versus Intermittent Caloric Restriction on Fat Loss BEHAVIORAL

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

Continuous Caloric Restriction (CCR) group:; Intermittent Caloric Restriction (ICR) group:

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coastal Carolina University: lead

Study Sites (1)

Williams Brice Building

Conway, South Carolina, 29526, United States

Location

Related Publications (4)

• Trexler ET, Smith-Ryan AE, Norton LE. Metabolic adaptation to weight loss: implications for the athlete. J Int Soc Sports Nutr. 2014 Feb 27;11(1):7. doi: 10.1186/1550-2783-11-7.

  PMID: 24571926 RESULT

• Fothergill E, Guo J, Howard L, Kerns JC, Knuth ND, Brychta R, Chen KY, Skarulis MC, Walter M, Walter PJ, Hall KD. Persistent metabolic adaptation 6 years after "The Biggest Loser" competition. Obesity (Silver Spring). 2016 Aug;24(8):1612-9. doi: 10.1002/oby.21538. Epub 2016 May 2.

  PMID: 27136388 RESULT

• Arguin H, Dionne IJ, Senechal M, Bouchard DR, Carpentier AC, Ardilouze JL, Tremblay A, Leblanc C, Brochu M. Short- and long-term effects of continuous versus intermittent restrictive diet approaches on body composition and the metabolic profile in overweight and obese postmenopausal women: a pilot study. Menopause. 2012 Aug;19(8):870-6. doi: 10.1097/gme.0b013e318250a287.

  PMID: 22735163 RESULT

• Byrne NM, Sainsbury A, King NA, Hills AP, Wood RE. Intermittent energy restriction improves weight loss efficiency in obese men: the MATADOR study. Int J Obes (Lond). 2018 Feb;42(2):129-138. doi: 10.1038/ijo.2017.206. Epub 2017 Aug 17.

  PMID: 28925405 RESULT

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Exercise Science

Model Details: All participants were randomized in a balanced fashion and stratified by body fat percentage into either one of the two intervention groups.

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: October 1, 2022
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)