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NCT Number: NCT07627256

Weight Loss Composition and Metabolic Adaptation During Hypocaloric Dieting

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypocaloric diet

Behavioral

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.

Primary outcomes

  1. Change in Resting Metabolic Rate

    Time frame: 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.

Secondary outcomes

  1. Change in Fat Mass

    Time frame: Baseline to end of dietary intervention (up to 12 months)

    Change in total body fat mass measured using dual-energy X-ray absorptiometry (DXA).

  2. Change in Fat-Free Mass

    Time frame: 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).

  3. Change in Body Weight

    Time frame: Baseline to end of dietary intervention (up to 12 months)

    Change in body weight measured using a calibrated digital scale.

  4. Change in Abdominal Circumference

    Time frame: 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.

  5. Intervention Duration

    Time frame: 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.

  6. Physical Activity Modality

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lien Bruck

CONTACT

[email protected]

+972 587487431

Yftach Prof. Gepner, PhD

CONTACT

[email protected]

+972 50-682-8501

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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