Weight Loss Composition and Metabolic Adaptation During Hypocaloric Dieting
ConditionObesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTel Aviv University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Hypocaloric Diet
BehavioralParticipants 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Hypocaloric Dietary InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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