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Weight Loss Composition and Metabolic Adaptation During Hypocaloric Dieting

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07627256
Enrollment
150
Registered
2026-06-04
Start date
2026-06-01
Completion date
2027-12-01
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Weight loss, Metabolic adaptation, Resting metabolic rate, Body composition, Fat-free mass, Energy expenditure, Hypocaloric diet

Brief summary

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.

Detailed description

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.

Interventions

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.

Sponsors

Tel Aviv University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants will follow individualized hypocaloric dietary plans designed to induce a moderate energy deficit based on measured resting metabolic rate. The study evaluates within-participant changes in body composition and resting metabolic rate during the intervention. All participants receive the same dietary approach, and changes from baseline to post-intervention are assessed.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Resting Metabolic RateBaseline 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

MeasureTime frameDescription
Change in Fat MassBaseline to end of dietary intervention (up to 12 months)Change in total body fat mass measured using dual-energy X-ray absorptiometry (DXA).
Change in Fat-Free MassBaseline to end of dietary intervention (up to 12 months)Change in total body fat-free mass measured using dual-energy X-ray absorptiometry (DXA).
Change in Body WeightBaseline to end of dietary intervention (up to 12 months)Change in body weight measured using a calibrated digital scale.
Change in Abdominal CircumferenceBaseline 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.
Intervention DurationBaseline 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.
Physical Activity ModalityBaseline 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.

Contacts

CONTACTYftach Prof. Gepner, PhD
gepner@tauex.tau.ac.il+972 50-682-8501
CONTACTLien Bruck
lienbruck@tauex.tau.ac.il+972 587487431
PRINCIPAL_INVESTIGATORYftach Gepner, PhD

Tel Aviv University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026