ObesityBREAKNCT05184361
Effects of Intermittent Versus Continuous Energy Restriction on Metabolic Adaptation in Women With Obesity
A study testing Intermittent energy restriction (IER) and Continuous energy restriction (CER) in people with Obesity and Weight Loss, run by Universidade do Porto at 1 site in Portugal.
Trial summary
One of the major challenges for treating obesity is to maintain a weight reduced state on the long term due to the high rate of weight regain. Therefore, the aim of this study is to evaluate the effects of an intermittent versus a continuous energy restriction in body composition (body weight, fat mass and fat-free… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Intermittent energy restriction (IER) and Continuous energy restriction (CER)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 sitePortugal
- Study dates
- 13 Jan 2022to 30 Jun 2024
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women
- BMI ranging between 30 and 39.9 kg/m2
- Age between 20-45 years
- Weight stable in the last 6 months (less than 5% weigh variation)
- Inactive (less then 150 min/week of moderate physical activity or 75 min/week of vigorous physical activity
- Living in Lisbon Metropolitan Area and being able to drive to Faculty of Human Kinetics and Germano de Sousa Laboratory (Algés)
- Available to be randomized to any of the trial groups (CER or IER)
- Willing to commit with the assigned group protocol, including the nutritional intervention and lifestyle recommendations, as well as being available for participation in all evaluation moments.
Who cannot join
- Previous or present health disorders: cancer, autoimmune, cardiac, psychiatric, kidney and liver disease (except liver steatosis), diabetes, chronic intestinal inflammatory disease, or other medical conditions known to affect energy balance homeostasis
- Menopause
- Hormonal or thyroid disorder
- Medications that promote weight gain or alter energy balance, including corticosteroids, antidepressants, anxiolytics, mood-stabilizing, and antipsychotics
- Medications or dietary supplements for weight-loss in the past 3 months
- Pregnant for the past 6 months or breastfeeding
Show all 10Show fewer
- Planning to get pregnant in the next 2 years or getting pregnant during the study
- Current consumption of more than 14 alcoholic drinks per week or other substance abuse, and/or current acute treatment or rehabilitation program for alcohol/substance abuse
- Surgery or in hospital admission for the last month
- Positive for Covid-19 in the past 3 months or testing positive during the intervention phase of the study
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculdade de Motricidade Humana da Universidade de Lisboa
Cruz Quebrada, Lisbon District, 1495-751
About this study
One of the major challenges for treating obesity is to maintain a weight reduced state on the long term due to the high rate of weight regain. Therefore, the aim of this study is to evaluate the effects of an intermittent versus a continuous energy restriction in body composition (body weight, fat mass and fat-free mass) and metabolic adaptation, in women with obesity.
Read the detailed description
Literature is full of lifestyle interventions aimed for weight loss (WL) in several populations. However, one of the major challenges for treating obesity is WL maintenance on the long term due to the high rate of weight regain.
The reduction of the resting metabolic rate (RMR) is one of the identified aspects regarding compensatory metabolic alterations. After a WL intervention, decreases in RMR are mainly explained by the loss of fat-mass (FM) and fat-free mass (FFM). However, some authors showed that these reductions tend to be higher than predicted (explained by FM and FFM loss), a phenomenon called "metabolic adaptation" (MA). MA has been studied as a possible barrier to WL, WL maintenance and may contribute to weight regain. However, its relevance on long-term WM has been recently questioned. It is known that in order to lose weight, a negative energy balance (EB) must be achieved, meaning when EE surpasses the energy intake (EI). However, this negative EB may be achieved through several strategies, by changing the EI (energy restriction (ER)) and/or EE (increasing physical activity).
Regarding EI strategies, continuous energy restriction (CER) is the most common nutritional strategy for WL, consisting in a daily energy restriction according to one's specific needs. However, some concern has been pointed out regarding this widely used strategy, once it evolves several behavioural, metabolic and endocrine responses that may contribute to therapeutic adherence, undermining WL and its maintenance. On the other hand, intermittent energy restriction (IER) has been recently suggested as an alternative to CER. IER consists in interspersing periods of ER with periods of neutral EB, called "refeed" or "diet breaks" during the WL phase. Energy restriction is followed by several adaptive responses, namely endocrine, including thyroid, appetite regulation and steroid hormones, influencing the energy expenditure (EE), body composition and satiety. Therefore, understanding how hormones may influence RMR and as a consequence, AT, it´s crucial to a better understanding.
According to the literature, compensatory metabolic responses following ER and WL can be reversed following a 7-to-14-day period of energy balance post-weight loss. Therefore, considering that the length of the nutritional intervention for WL may benefit a reduction, we consider relevant to study other ER designs/patterns, namely 2 weeks in ER interspersed with 1 week in EB, comparing to a CER. Taking into account this therapeutic as a potential opportunity for the obesity's treatment, this paper describes the protocol for a randomized controlled trial (RCT), which targets to evaluate the effects of an IER (alternating 2 weeks of ER with 1 in neutral EB), comparing to a CER. This trial aims: a) to compare the effects of a IER vs CER strategy on body composition variables (body weight, fat mass and fat-free mass) and in metabolic adaptation and, b) to understand if participants will be able to maintain a reduced weight state after 12 months (successful weight-loss maintenance), in both groups.
- Conditions
- Obesity, Weight Loss
- Being tested
- Intermittent energy restriction (IER), Continuous energy restriction (CER)
- Keywords
- Adaptive Thermogenesis, Metabolic Slowing
- 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.
Intermittent energy restriction (IER)Behavioural
Both groups will be accompanied by a registered dietitian in order to provide an individual and personalized diet plan that will suppress the respective daily requirements for each phase. Macronutrient distribution will be the following: 35% protein, 35% carbohydrate and 30% fat.
Daily energy requirements (DER) will be calculated by multiplying measured RMR (through indirect calorimetry) by physical activity level (PAL), assessed by accelerometry.
In order to achieve a neutral EB, 100% of their daily energy requirements (DER) will be prescribed for each participant. For both groups, an energy restriction of 33% of one's DER will be created. The IER group will alternate between 2-weeks in energy restriction (67% DER) and 1-week in neutral EB (100% DER), in a total of 23-weeks.
The IER group will alternate between 2-weeks in energy restriction (67% DER) and 1-week in neutral EB (100% DER), in a total of 23-weeks.
Continuous energy restriction (CER)Behavioural
A dietary plan comprising 67% of DER will be prescribed to the CER group. Participants will be asked to follow this plan in a total of 16-weeks, without interruptions.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent energy restriction (IER) | Experimental | Initially participants will undergo 2-weeks of neutral energy balance (EB). After this, the IER will consist of: 2-weeks of energy restriction interspersed with 1-week in neutral EB (total of 23-week period).
At the end, 8-weeks in neutral EB will be required. Receives: Behavioral: Intermittent energy restriction (IER) |
| Continuous energy restriction (CER) | Active comparator | Similarly to IER, CER participants will undergo 2-weeks of neutral EB. After this, the CER will consist of: 16-weeks of continuous energy restriction. At the end, 8-weeks in neutral EB will be required. Receives: Behavioral: Continuous energy restriction (CER) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass
To estimate total fat mass (FM), dual energy X-ray absorptiometry (Hologic Explorer-W, Waltham, USA) will be used. A whole-body scan will be performed and the attenuation of X-rays pulsed between 70 and 140 kV synchronously with the line frequency for each pixel of the scanned image will be measured.
Measured: 24 months
Adaptive thermogenesis (AT)
AT will be assessed as: AT (kcal/d) = (pREE at the end of the intervention - mREE at the end of the intervention) - (pREE baseline - mREE baseline)
Measured: 24 months
Secondary outcomes (13)
Weight
Weight will be determined using a digital scale, with 0,1 kg interval (Seca, Hamburg, Germany).
Measured: 24 months
Height
Height will be determined using a stadiometer Seca 704 s, with 0,1 cm intervals (Seca, Hamburg, Germany)
Measured: Baseline
Body mass index (BMI)
BMI will be calculated using the formula [weight (kg)/height2(m2)]
Measured: 24 months
Fat-free mass (FFM)
To estimate fat-free mass (FFM), dual energy X-ray absorptiometry (Hologic Explorer-W, Waltham, USA) will be used. A whole-body scan will be performed and the attenuation of X-rays pulsed between 70 and 140 kV synchronously with the line frequency for each pixel of the scanned image will be measured.
Measured: 24 months
Resting energy expenditure (REE)
REE will be determined using indirect calorimetry COSMED Fitmate device (Cosmed, Rome, Italy) will be used to measure breath-by-breath oxygen consumption (V̇O2 ) and carbon dioxide production (V̇CO2) using a facial mask.
Measured: 24 months
Energy balance (EB)
The EB will be calculated as: EB (kcal/d) = 1.0 * (ΔFMM/Δt) + 9.5 * (ΔFM/Δt). ΔFM and ΔFFM represent the change in grams of FM and FFM from the beginning to end of the intervention and Δt is the time length of the intervention in days.
Measured: 24 months
Free-living physical activity
The amount of activity assessed by the Actigraph accelerometer will be expressed as minutes per day spent in different intensities. The cutoff values used to define the intensity of PA and therefore to quantify the mean time in each intensity (sedentary, light, moderate or vigorous) will be: sedentary: < 100 counts·min-1; light: 100-2019 counts·min-1; moderate: 2020-5998 counts·min-1 (corresponding to 3-5.9 METs); vigorous: ≥ 5999 counts·min-1 (corresponding to ≥6 METs). A valid day will be defined as having 600 or more minutes (≥10h) of monitor wear during waking hours.
Measured: 24 months
Total daily energy expenditure (TDEE)
TDEE will be assessed by the Actigraph accelerometer using the Crouter et al equations.
Measured: 24 months
Physical activity energy expenditure (PAEE)
PAEE will be calculated as total energy expenditure (TEE) minus (0.1*TEE + REE), assuming the thermic effect of food represents 10% of TEE, and REE represents Resting energy expenditure.
Measured: 24 months
Blood thyroid levels
Free T3 and free T4 will be run by immunoassay with chemiluminescent detection (Advia Centaur, Siemens).
Measured: 24 months
Blood insulin levels
Blood insulin levels assessment will be performed in an automated analyser with chemiluminescent detection [Advia Centaur, Siemens].
Measured: 24 months
Blood leptin levels
Serum levels of leptin will be measured by enzyme immunoassay [ELISA].
Measured: 24 months
Blood cortisol levels
Blood levels of cortisol will be determined by immunoassay with chemiluminescence detection [Advia Centaur, Siemens].
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start13 Jan 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lisbon
- Responsible party
- Sponsor
- Investigators
- Vítor H Teixeira, PhD, Principal investigator, Faculty of Nutrition and Food Sciences, University of PortoAnaliza M Silva, PhD, Principal investigator, Faculty of Human Kinetics, University of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184361
- Sponsor's protocol ID
- BREAKSTUDY2021
- Acronym
- BREAK
- Status last verified
- Jan 2025
- First submitted
- 17 Dec 2021
- Last updated
- 22 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cortez FM, Nunes CL, Sardinha LB, Silva AM, Teixeira VH. The BREAK study protocol: Effects of intermittent energy restriction on adaptive thermogenesis during weight loss and its maintenance. PLoS One. 2023 Nov 13;18(11):e0294131. doi: 10.1371/journal.pone.0294131. eCollection 2023.
PubMed 37956119
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intermittent Versus Continuous Energy Restriction on Metabolic Adaptation in Women With Obesity
- ClinicalTrials.gov ID
- NCT05184361
- Acronym / sponsor ID
- BREAK / BREAKSTUDY2021
- Conditions
- Obesity, Weight Loss
- Keywords
- Adaptive Thermogenesis, Metabolic Slowing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- University of Lisbon
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the major challenges for treating obesity is to maintain a weight reduced state on the long term due to the high rate of weight regain. Therefore, the aim of this study is to evaluate the effects of an intermittent versus a continuous energy restriction in body composition (body weight, fat mass and fat-free mass) and metabolic adaptation, in women with obesity.
Detailed description
Literature is full of lifestyle interventions aimed for weight loss (WL) in several populations. However, one of the major challenges for treating obesity is WL maintenance on the long term due to the high rate of weight regain.
The reduction of the resting metabolic rate (RMR) is one of the identified aspects regarding compensatory metabolic alterations. After a WL intervention, decreases in RMR are mainly explained by the loss of fat-mass (FM) and fat-free mass (FFM). However, some authors showed that these reductions tend to be higher than predicted (explained by FM and FFM loss), a phenomenon called "metabolic adaptation" (MA). MA has been studied as a possible barrier to WL, WL maintenance and may contribute to weight regain. However, its relevance on long-term WM has been recently questioned. It is known that in order to lose weight, a negative energy balance (EB) must be achieved, meaning when EE surpasses the energy intake (EI). However, this negative EB may be achieved through several strategies, by changing the EI (energy restriction (ER)) and/or EE (increasing physical activity).
Regarding EI strategies, continuous energy restriction (CER) is the most common nutritional strategy for WL, consisting in a daily energy restriction according to one's specific needs. However, some concern has been pointed out regarding this widely used strategy, once it evolves several behavioural, metabolic and endocrine responses that may contribute to therapeutic adherence, undermining WL and its maintenance. On the other hand, intermittent energy restriction (IER) has been recently suggested as an alternative to CER. IER consists in interspersing periods of ER with periods of neutral EB, called "refeed" or "diet breaks" during the WL phase. Energy restriction is followed by several adaptive responses, namely endocrine, including thyroid, appetite regulation and steroid hormones, influencing the energy expenditure (EE), body composition and satiety. Therefore, understanding how hormones may influence RMR and as a consequence, AT, it´s crucial to a better understanding.
According to the literature, compensatory metabolic responses following ER and WL can be reversed following a 7-to-14-day period of energy balance post-weight loss. Therefore, considering that the length of the nutritional intervention for WL may benefit a reduction, we consider relevant to study other ER designs/patterns, namely 2 weeks in ER interspersed with 1 week in EB, comparing to a CER. Taking into account this therapeutic as a potential opportunity for the obesity's treatment, this paper describes the protocol for a randomized controlled trial (RCT), which targets to evaluate the effects of an IER (alternating 2 weeks of ER with 1 in neutral EB), comparing to a CER. This trial aims: a) to compare the effects of a IER vs CER strategy on body composition variables (body weight, fat mass and fat-free mass) and in metabolic adaptation and, b) to understand if participants will be able to maintain a reduced weight state after 12 months (successful weight-loss maintenance), in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent energy restriction (IER) | Experimental | Behavioral: Intermittent energy restriction (IER)Initially participants will undergo 2-weeks of neutral energy balance (EB). After this, the IER will consist of: 2-weeks of energy restriction interspersed with 1-week in neutral EB (total of 23-week period). At the end, 8-weeks in neutral EB will be required. |
| Continuous energy restriction (CER) | Active comparator | Behavioral: Continuous energy restriction (CER)Similarly to IER, CER participants will undergo 2-weeks of neutral EB. After this, the CER will consist of: 16-weeks of continuous energy restriction. At the end, 8-weeks in neutral EB will be required. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women
- BMI ranging between 30 and 39.9 kg/m2
- Age between 20-45 years
- Weight stable in the last 6 months (less than 5% weigh variation)
- Inactive (less then 150 min/week of moderate physical activity or 75 min/week of vigorous physical activity
Key exclusion criteria (10 listed)
- Previous or present health disorders: cancer, autoimmune, cardiac, psychiatric, kidney and liver disease (except liver steatosis), diabetes, chronic intestinal inflammatory disease, or other medical conditions known to affect energy balance homeostasis
- Menopause
- Hormonal or thyroid disorder
- Medications that promote weight gain or alter energy balance, including corticosteroids, antidepressants, anxiolytics, mood-stabilizing, and antipsychotics
- Medications or dietary supplements for weight-loss in the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent energy restriction (IER)Both groups will be accompanied by a registered dietitian in order to provide an individual and personalized diet plan that will suppress the respective daily requirements for each phase. Macronutrient distribution will be the following: 35% protein, 35% carbohydrate and 30% fat. Daily energy requirements (DER) will be calculated by multiplying measured RMR (through indirect calorimetry) by physical activity level (PAL), assessed by accelerometry. In order to achieve a neutral EB, 100% of their daily energy requirements (DER) will be prescribed for each participant. For both groups, an energy restriction of 33% of one's DER will be created. The IER group will alternate between 2-weeks in energy restriction (67% DER) and 1-week in neutral EB (100% DER), in a total of 23-weeks. The IER group will alternate between 2-weeks in energy restriction (67% DER) and 1-week in neutral EB (100% DER), in a total of 23-weeks. | Behavioural | Intermittent energy restriction (IER) |
| Continuous energy restriction (CER)A dietary plan comprising 67% of DER will be prescribed to the CER group. Participants will be asked to follow this plan in a total of 16-weeks, without interruptions. | Behavioural | Continuous energy restriction (CER) |
Primary outcome
Fat mass
Time frame: 24 months
To estimate total fat mass (FM), dual energy X-ray absorptiometry (Hologic Explorer-W, Waltham, USA) will be used. A whole-body scan will be performed and the attenuation of X-rays pulsed between 70 and 140 kV synchronously with the line frequency for each pixel of the scanned image will be measured.
Adaptive thermogenesis (AT)
Time frame: 24 months
AT will be assessed as: AT (kcal/d) = (pREE at the end of the intervention - mREE at the end of the intervention) - (pREE baseline - mREE baseline)
13 secondary outcomes
Weight
Time frame: 24 months
Height
Time frame: Baseline
Body mass index (BMI)
Time frame: 24 months
Fat-free mass (FFM)
Time frame: 24 months
Resting energy expenditure (REE)
Time frame: 24 months
Energy balance (EB)
Time frame: 24 months
Free-living physical activity
Time frame: 24 months
Total daily energy expenditure (TDEE)
Time frame: 24 months
Physical activity energy expenditure (PAEE)
Time frame: 24 months
Blood thyroid levels
Time frame: 24 months
Blood insulin levels
Time frame: 24 months
Blood leptin levels
Time frame: 24 months
Blood cortisol levels
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Derived from this study: PubMed 37956119Cortez FM, Nunes CL, Sardinha LB, Silva AM, Teixeira VH. The BREAK study protocol: Effects of intermittent energy restriction on adaptive thermogenesis during weight loss and its maintenance. PLoS One. 2023 Nov 13;18(11):e0294131. doi: 10.1371/journal.pone.0294131. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vítor H Teixeira, PhD principal investigator
Faculty of Nutrition and Food Sciences, University of Porto
Analiza M Silva, PhD principal investigator
Faculty of Human Kinetics, University of Lisbon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent energy restriction (IER) and Continuous energy restriction (CER) in people with Obesity and Weight Loss, run by Universidade do Porto at 1 site in Portugal.
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 8 inclusion and 10 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 22 Jul 2026. 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 Portugal. 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 mass (time frame: 24 months). The study lists 2 primary outcomes in all. 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 NCT05184361, which also lists 1 linked publication.
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 22 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.