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Weight Loss Composition and Metabolic Adaptation During Hypocaloric Dieting

31 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

150

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Resting Metabolic Rate
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Fat Mass
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 décembre 2027

Achèvement de l'étude (Estimé)

1 décembre 2027

Dates d'inscription aux études

Première soumission

31 mai 2026

Première soumission répondant aux critères de contrôle qualité

31 mai 2026

Première publication (Réel)

4 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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