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ObesityNCT06079658

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

A study testing Continuous Caloric Restriction versus Intermittent Caloric Restriction on Fat Loss in people with Obesity, run by Coastal Carolina University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Continuous Caloric Restriction versus Intermittent Caloric Restriction on Fat Loss
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
1 Oct 2022to 15 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Williams Brice Building

    Conway, South Carolina, 29526

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Obesity
Being tested
Continuous Caloric Restriction versus Intermittent Caloric Restriction on Fat Loss
Keywords
Weight Loss, Telehealth, health Coaching, Diet Breaks
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Caloric Restriction versus Intermittent Caloric Restriction on Fat LossBehavioural

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

Study groups in NCT06079658
Study groupRoleWhat they receive
Continuous Caloric Restriction (CCR) group:ExperimentalParticipants 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.
Receives: Behavioral: Continuous Caloric Restriction versus Intermittent Caloric Restriction on Fat Loss
Intermittent Caloric Restriction (ICR) group:ExperimentalParticipants 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.
Receives: Behavioral: Continuous Caloric Restriction versus Intermittent Caloric Restriction on Fat Loss

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fat Loss

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

    Measured: Change in fat mass between baseline (week 0) and post intervention (week 12)

Secondary outcomes (1)

  1. % Weight Loss

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2023
  2. Study start1 Oct 2022
  3. Primary completion15 Aug 2023
  4. Study completion15 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
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 blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06079658
Sponsor's protocol ID
2023.06
Status last verified
Oct 2023
First submitted
6 Oct 2023
Last updated
12 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24571926

  • 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.

    PubMed 27136388

  • 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.

    PubMed 22735163

  • 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.

    PubMed 28925405

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Caloric Restriction versus Intermittent Caloric Restriction on Fat Loss in people with Obesity, run by Coastal Carolina University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fat Loss (time frame: Change in fat mass between baseline (week 0) and post intervention (week 12)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06079658, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.

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