NCT05184361

Brief 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 mass) and metabolic adaptation, in women with obesity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

January 13, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

2.4 years

First QC Date

December 17, 2021

Last Update Submit

December 27, 2023

Conditions

ObesityWeight Loss

Keywords

Adaptive ThermogenesisMetabolic Slowing

Outcome Measures

Primary Outcomes (2)

  • 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.

    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)

    24 months

Secondary Outcomes (13)

  • Weight

    24 months

  • Height

    Baseline

  • Body mass index (BMI)

    24 months

  • Fat-free mass (FFM)

    24 months

  • Resting energy expenditure (REE)

    24 months

  • +8 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Continuous energy restriction (CER)

Interventions

Intermittent energy restriction (IER)BEHAVIORAL

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.

Intermittent energy restriction (IER)
Continuous energy restriction (CER)BEHAVIORAL

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.

Continuous energy restriction (CER)

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Motricidade Humana da Universidade de Lisboa

Cruz Quebrada, Lisbon District, 1495-751, Portugal

Location

Related Publications (1)

  • 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.

    PMID: 37956119DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Vítor H Teixeira, PhD

    Faculty of Nutrition and Food Sciences, University of Porto

    PRINCIPAL INVESTIGATOR

  • Analiza M Silva, PhD

    Faculty of Human Kinetics, University of Lisbon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2021

First Posted

January 11, 2022

Study Start

January 13, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

January 3, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)