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

Summary

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.

Conditions

• Obesity

Interventions

BEHAVIORAL

Low-Energy High-Protein Diet

This intervention consists of a 12-week low-energy high-protein diet program delivered through structured behavioral and nutritional counseling. Nutrition care process: individual nutritional counseling, one-on-one counseling session conducted by a registered dietitian. The dietary regimen is prescribed with an energy deficit of 500-750 kcal/day, ensuring a minimum daily energy intake of 1.200 kcal/day for women and 1.500 kcal/day for men. Macronutrient distribution is targeted at 1.2-1.6 g/kg adjusted body weight for protein, 20-30% of total energy for fat, and 45-55% of total energy for carbohydrates. Genetic profiling using the Gens-HiPro score is conducted to evaluate its role as a modifier of outcome responses in weight loss, body composition, and biochemical parameters.

Sponsors & Collaborators

• Universitas Jenderal Soedirman

  collaborator OTHER

• Faculty of Medicine, Gadjah Mada University

  collaborator UNKNOWN

• Gadjah Mada University

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2026-12-31

Completion

2027-01-31

Countries

• Indonesia

Study Locations