An interventional study of Hypocaloric Diet in Obesity, sponsored by Tel Aviv University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Tel Aviv University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria
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.
Behavioral: Hypocaloric Diet
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.
Change in Resting Metabolic Rate
Change in resting metabolic rate (RMR) measured by indirect calorimetry between baseline and post-intervention assessment.
Time frame: Baseline to end of dietary intervention (up to 12 months)
Change in Fat Mass
Change in total body fat mass measured using dual-energy X-ray absorptiometry (DXA).
Time frame: Baseline to end of dietary intervention (up to 12 months)
Change in Fat-Free Mass
Change in total body fat-free mass measured using dual-energy X-ray absorptiometry (DXA).
Time frame: Baseline to end of dietary intervention (up to 12 months)
Change in Body Weight
Change in body weight measured using a calibrated digital scale.
Time frame: Baseline to end of dietary intervention (up to 12 months)
Change in Abdominal Circumference
Change in abdominal circumference measured using a standardized anthropometric tape at the midpoint between the lowest rib and iliac crest.
Time frame: Baseline to end of dietary intervention (up to 12 months)
Intervention Duration
Total duration of participation in the hypocaloric dietary intervention, recorded in weeks from baseline to intervention completion.
Time frame: Baseline to end of intervention (up to 12 months)
Physical Activity Modality
Self-reported type of physical activity performed during the intervention, categorized as aerobic, resistance, combined, or none.
Time frame: Baseline to end of dietary intervention (up to 12 months)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tel Aviv University