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Development of a Genetic Score as a Response Modifier for Changes in Weight, Body Composition, and Biochemical Parameters in Obese Adults Undergoing a Low-Energy High-Protein Diet Intervention

NCT07760870

Not Yet RecruitingNA

Sponsor: Gadjah Mada University

Conditions: Obesity

Interventions: Low-Energy High-Protein Diet

Countries: Indonesia

The goal of this clinical trial is to evaluate whether a genetic score (Gens-HiPro) acts as a response modifier for weight loss, body composition changes, and biochemical parameters in obese adults undergoing a low-energy high-protein diet intervention. The main questions it aims to answer is: Does the genetic score (Gens-HiPro) modify responses to changes in weight, body composition, and biochemical parameters following a 12-week low-energy high-protein diet? Participants will: * Undergo initial screening to determine eligibility based on inclusion and exclusion criteria * Complete baseline data measurement, including demographic data, anthropometric measurements (weight, BMI, body composition), biochemical blood analysis (total cholesterol, triglycerides, HDL, LDL, CRP), dietary assessment. * Attend a small-group educational session on general guidelines, portion control, plate model ("Isi Piringku"), and food weighing techniques for a low-energy high-protein diet. * Receive a 60-90 minute nutritional counseling session led by a dietitian at the start of intervention * Follow the prescribed 12-week low-energy high-protein diet, supported by an active messaging channel on weekdays for daily dietary consultations * Participate in at least three in-person monitoring and evaluation visits scheduled every 3-4 weeks (at weeks 4, 8, and 12 or weeks 4, 7, 10 and 12) * Complete post-intervention evaluations at the end of week 12, repeating all baseline anthropometric, biochemical, and dietary assessments.

Eligibility overview

Sex: ALL

Age: 18 Years to 40 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Adult males or females aged 18 - 40 years.
* Classified as obese with a Body Mass Index (BMI) of 27 - 35 kg/m² and a waist circumference of ≥90 cm for men and ≥80 cm for women.
* Willing to adhere to the prescribed low-energy high-protein diet.
* Willing to undergo anthropometric measurements, body composition analysis, lipid profile testing, and genetic variation screening.
* Signed the written informed consent form.

Exclusion Criteria:

* Having chronic diseases that affect metabolism or body weight.
* Diagnosed with chronic kidney disease (CKD).
* Currently pregnant, lactating, or planning a pregnancy during the study period.
* Currently participating in an intensive weight loss program or receiving pharmacological therapy for weight loss within the last 3 months.

Locations (1)

Banyumas, Central Java, Indonesia