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 Recruiting

• 3 other identifiers: 092/KEPK/PE/VII/2026202406210804017548/UN1/FKKMK.3/S3KK.3/PJ/2026
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

obesity; nutrigenetics; genetic variation; low-energy high-protein diet; genetic score; gens-hipro

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight

  Body weight refers to the total body mass of the subject, measured using a weighing scale in kilograms (kg). The change in body weight is calculated as the difference between the body weight value at the baseline of the intervention (Week 0) and the end of the intervention (Week 12). (Scale: Ratio)

  12 weeks

Secondary Outcomes (5)

• Change in Body Mass Index (BMI)

  12 weeks

• Change in Fat Mass

  12 weeks

• Change in Muscle Mass

  12 weeks

• Change in Visceral Fat

  12 weeks

• Change in Waist Circumference

  12 weeks

Other Outcomes (5)

• Change in Fasting Serum Triglycerides

  12 weeks

• Change in Fasting Serum High-Density Lipoprotein (HDL) Cholesterol

  12 weeks

• Change in Fasting Serum Low-Density Lipoprotein (LDL) Cholesterol

  12 weeks

Study Arms (1)

low-energy high-protein diet intervention

EXPERIMENTAL

Participants in this single-arm study will undergo a 12-week low-energy high-protein diet intervention (personalized nutritional counseling by a dietitian).

Behavioral: Low-Energy High-Protein Diet

Interventions

Low-Energy High-Protein Diet BEHAVIORAL

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.

low-energy high-protein diet intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gadjah Mada University: lead
• Universitas Jenderal Soedirman: collaborator
• Faculty of Medicine, Gadjah Mada University: collaborator

Study Sites (1)

Integrated Health Science Building, Faculty of Health Sciences

Banyumas, Central Java, 53122, Indonesia

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yovita Puri Subardjo, S.Gz., Dietisien, MPH

CONTACT

+628174100488; yovitapurisubardjo@mail.ugm.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: S.Gz., Dietisien, MPH

Model Details: single-arm, one-group pre-post interventional study

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)