Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Weight Loss Composition and Metabolic Adaptation During Hypocaloric Dieting

31 de maio de 2026 atualizado por: Gepner Yftach, Tel Aviv University

The Relationship Between Weight Loss Composition, Body Composition Changes, and Metabolic Adaptation During a Hypocaloric Dietary Intervention

Weight loss induced by hypocaloric dietary interventions is commonly accompanied by reductions in resting metabolic rate (RMR), a phenomenon often described as metabolic adaptation. The magnitude of this decline varies substantially between individuals and may depend not only on the amount of weight lost but also on the composition of weight loss, particularly the relative contributions of fat mass and fat-free mass.

This prospective interventional study will investigate whether changes in body composition during a hypocaloric dietary intervention are associated with changes in RMR and metabolic adaptation. Approximately 150 adults with overweight or obesity will participate in a structured dietary program designed to induce moderate energy restriction. Body composition and resting metabolic rate will be assessed before and after the intervention to evaluate associations between fat mass loss, fat-free mass loss, and metabolic responses to weight reduction.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Weight loss achieved through caloric restriction is consistently associated with reductions in resting metabolic rate (RMR). In many individuals, the decrease in energy expenditure exceeds what would be predicted from the loss of body mass or body composition alone, a phenomenon commonly described as metabolic adaptation or adaptive thermogenesis. This response has been proposed as one potential contributor to the difficulty many individuals experience in maintaining weight loss over time.

Fat-free mass is the primary determinant of resting energy expenditure because it includes metabolically active tissues such as skeletal muscle and organs. Consequently, the relative proportion of fat mass and fat-free mass lost during weight reduction may influence the magnitude of RMR decline. Dietary strategies that promote preservation of fat-free mass, such as adequate protein intake and engagement in physical activity, may attenuate metabolic slowing during weight loss. However, substantial inter-individual variability in metabolic responses to weight loss has been reported, and the role of weight-loss composition in shaping these responses remains incompletely understood.

The present study aims to examine the relationship between changes in body composition and changes in resting metabolic rate during a structured hypocaloric dietary intervention in adults with overweight or obesity. Participants will follow individualized dietary plans designed to produce a moderate energy deficit. Body composition will be assessed using dual-energy X-ray absorptiometry (DXA), and resting metabolic rate will be measured using indirect calorimetry at baseline and following completion of the intervention. Anthropometric measures and physical activity patterns will also be recorded.

By evaluating the relative contributions of fat mass loss and fat-free mass loss to changes in energy expenditure, this study aims to improve understanding of the physiological responses to weight reduction. The findings may help inform weight-loss strategies designed to minimize unfavorable metabolic adaptations and support more sustainable long-term weight management.

Tipo de estudo

Intervencional

Inscrição (Estimado)

150

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria

  • Adults aged 18 years and older.
  • Individuals living with overweight or obesity.
  • Willingness and ability to comply with dietary recommendations and study procedures.
  • Provision of written informed consent.

Exclusion Criteria

  • Diagnosed metabolic or endocrine disorders known to affect energy expenditure.
  • Use of medications known to substantially affect metabolism or body composition.
  • Pregnancy or breastfeeding.
  • Any medical condition that, in the opinion of the investigators, precludes safe participation.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Hypocaloric Dietary Intervention
Participants will follow individualized hypocaloric dietary plans designed to produce a moderate daily energy deficit based on measured resting metabolic rate. The intervention focuses on dietary energy restriction while supporting preservation of fat-free mass through adequate protein intake. Body composition and resting metabolic rate will be assessed before and after the intervention to evaluate metabolic responses to weight loss.
Participants will follow individualized dietary plans designed to produce an energy deficit of approximately 500-600 kcal/day relative to measured resting metabolic rate. Protein intake will be prescribed at approximately 1.5 g/kg body weight per day to support preservation of fat-free mass. Dietary plans will be adjusted as needed during the intervention period, and participants will attend regular follow-up visits to monitor progress and adherence.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Resting Metabolic Rate
Prazo: Baseline to end of dietary intervention (up to 12 months)
Change in resting metabolic rate (RMR) measured by indirect calorimetry between baseline and post-intervention assessment.
Baseline to end of dietary intervention (up to 12 months)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Fat Mass
Prazo: Baseline to end of dietary intervention (up to 12 months)
Change in total body fat mass measured using dual-energy X-ray absorptiometry (DXA).
Baseline to end of dietary intervention (up to 12 months)
Change in Fat-Free Mass
Prazo: Baseline to end of dietary intervention (up to 12 months)
Change in total body fat-free mass measured using dual-energy X-ray absorptiometry (DXA).
Baseline to end of dietary intervention (up to 12 months)
Change in Body Weight
Prazo: Baseline to end of dietary intervention (up to 12 months)
Change in body weight measured using a calibrated digital scale.
Baseline to end of dietary intervention (up to 12 months)
Change in Abdominal Circumference
Prazo: Baseline to end of dietary intervention (up to 12 months)
Change in abdominal circumference measured using a standardized anthropometric tape at the midpoint between the lowest rib and iliac crest.
Baseline to end of dietary intervention (up to 12 months)
Intervention Duration
Prazo: Baseline to end of intervention (up to 12 months)
Total duration of participation in the hypocaloric dietary intervention, recorded in weeks from baseline to intervention completion.
Baseline to end of intervention (up to 12 months)
Physical Activity Modality
Prazo: Baseline to end of dietary intervention (up to 12 months)
Self-reported type of physical activity performed during the intervention, categorized as aerobic, resistance, combined, or none.
Baseline to end of dietary intervention (up to 12 months)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Yftach Gepner, PhD, Tel Aviv University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2027

Conclusão do estudo (Estimado)

1 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

31 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

31 de maio de 2026

Primeira postagem (Real)

4 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever