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

ConditionObesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorGadjah Mada University

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Low-Energy High-Protein Diet

Treatment groups

29 Participants
are divided into 1 treatment group

Sponsors and collaborators

Gadjah Mada University

Lead sponsor

Universitas Jenderal Soedirman

Collaborator

Faculty of Medicine, Gadjah Mada University

Collaborator