Effects of Intermittent Versus Continuous Energy Restriction on Metabolic Adaptation in Women With Obesity

NCT05184361 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2024-01-03

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • University of Lisbon

    collaborator OTHER
  • Universidade do Porto

    lead OTHER

Principal Investigators

  • Vítor H Teixeira, PhD · Faculty of Nutrition and Food Sciences, University of Porto

  • Analiza M Silva, PhD · Faculty of Human Kinetics, University of Lisbon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-13
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Portugal

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05184361 on ClinicalTrials.gov