NCT07760870Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 29 (estimated)
- First submitted
- 7 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Gadjah Mada University
- Diseases
- Obesity
- NCT number
- NCT07760870
What you commit to
- Study type: Interventional
- Planned participants: 29
- From 1 Sept 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently participating in an intensive weight loss program or receiving pharmacological therapy for weight loss within the last 3 months.
Other illness
- Having chronic diseases that affect metabolism or body weight.
- Diagnosed with chronic kidney disease (CKD).
Other
- Currently pregnant, lactating, or planning a pregnancy during the study period.
Who the study is looking for
- 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.
Age in the registry: 18 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Integrated Health Science Building, Faculty of Health Sciences Coordinator of this site? Confirm its status | Banyumas | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.