ObesityGens-HiProNCT07760870
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
A study testing Low-Energy High-Protein Diet in people with Obesity, run by Gadjah Mada University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Obesity
- What is being tested?
- Low-Energy High-Protein Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Integrated Health Science Building, Faculty of Health Sciences
Banyumas, Central Java, 53122
Adendita Azmi Afiattami, S.Gz, +6285117481147, adendita.azmi@unsoed.ac.id
About this study
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:
Read more
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.
Read the detailed description
Subjects will be stratified or analyzed based on their genetic profile using the Gens-HiPro score to evaluate gene-diet interactions on weight loss outcomes. Gens-HiPro Genetic Score: A genetic risk score calculated as the sum of the products of each selected single nucleotide variant's (SNV) allele score and its respective effect size (mean difference [MD] in weight loss between allele groups). The selected genetic variants were screened and identified through a systematic review and meta-analysis, including: APOA1 rs670, CB2R/CNR2 rs3123554, FTO rs1421085, FTO rs9939609, MC4R rs17782313, and MTNR1B rs10830963. An allele score of 0 is assigned if a specific genetic variant falls into the genotype group with a smaller mean difference in weight loss. An allele score of 1 is assigned if the variant falls into the genotype group with a larger mean difference. The effect size represents the mean difference in weight loss, calculated by subtracting the mean weight loss of the genotype group with the smaller MD from the mean weight loss of the genotype group with the larger MD.
- Conditions
- Obesity
- Being tested
- Low-Energy High-Protein Diet
- Keywords
- obesity, nutrigenetics, genetic variation, low-energy high-protein diet, genetic score, gens-hipro
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Energy High-Protein DietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Low-Energy High-Protein Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (5)
Change in Body Mass Index (BMI)
Body Mass Index is the ratio of the subject's body weight in kilograms divided by the square of their height in meters (kg/m²). The change in BMI is calculated as the difference between the BMI value at the baseline of the intervention (Week 0) and the end of the intervention (Week 12). (Scale: Ratio)
Measured: 12 weeks
Change in Fat Mass
Fat mass is the total amount of fat present in the subject's body, measured using Bioelectrical Impedance Analysis (BIA). The change in fat mass is calculated as the difference between the fat mass value in kg at the baseline of the intervention (Week 0) and the end of the intervention (Week 12). (Scale: Ratio)
Measured: 12 weeks
Change in Muscle Mass
Muscle mass refers to the total amount of muscle (skeletal muscle mass) in the subject's body, measured using Bioelectrical Impedance Analysis (BIA). The change in muscle mass is calculated as the difference between the muscle mass value in kg at the baseline of the intervention (Week 0) and the end of the intervention (Week 12). (Scale: Ratio)
Measured: 12 weeks
Change in Visceral Fat
isceral fat is the fat stored within the abdominal cavity that surrounds the subject's internal organs, measured using Bioelectrical Impedance Analysis (BIA). The change in visceral fat mass is calculated as the difference between the visceral fat mass value at the baseline of the intervention (Week 0) and the end of the intervention (Week 12). (Scale: Ratio)
Measured: 12 weeks
Change in Waist Circumference
Waist circumference is a simple physical measurement taken using a measuring tape (metline) around the abdomen to estimate central obesity, reported in centimeters (cm). The change in waist circumference is calculated as the difference between the waist circumference value at the baseline of the intervention (Week 0) and the end of the intervention (Week 12). (Scale: Ratio)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-arm, one-group pre-post interventional study
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Jenderal Soedirman, Faculty of Medicine, Gadjah Mada University
- Responsible party
- Principal investigator, Yovita Puri Subardjo, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760870
- Sponsor's protocol ID
- 092/KEPK/PE/VII/2026
- Other IDs
- 202406210804017, 092/KEPK/PE/VII/2026, 548/UN1/FKKMK.3/S3KK.3/PJ/2026
- Acronym
- Gens-HiPro
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient privacy and confidentiality, in accordance with the informed consent signed by the participants and the restrictions set by the Institutional Review Board (IRB) / Ethics Committee.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07760870
- Acronym / sponsor ID
- Gens-HiPro / 092/KEPK/PE/VII/2026
- Conditions
- Obesity
- Keywords
- obesity, nutrigenetics, genetic variation, low-energy high-protein diet, genetic score, gens-hipro
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Collaborators
- Universitas Jenderal Soedirman, Faculty of Medicine, Gadjah Mada University
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects will be stratified or analyzed based on their genetic profile using the Gens-HiPro score to evaluate gene-diet interactions on weight loss outcomes. Gens-HiPro Genetic Score: A genetic risk score calculated as the sum of the products of each selected single nucleotide variant's (SNV) allele score and its respective effect size (mean difference [MD] in weight loss between allele groups). The selected genetic variants were screened and identified through a systematic review and meta-analysis, including: APOA1 rs670, CB2R/CNR2 rs3123554, FTO rs1421085, FTO rs9939609, MC4R rs17782313, and MTNR1B rs10830963. An allele score of 0 is assigned if a specific genetic variant falls into the genotype group with a smaller mean difference in weight loss. An allele score of 1 is assigned if the variant falls into the genotype group with a larger mean difference. The effect size represents the mean difference in weight loss, calculated by subtracting the mean weight loss of the genotype group with the smaller MD from the mean weight loss of the genotype group with the larger MD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-arm, one-group pre-post interventional study
| Arm | Type | Receives |
|---|---|---|
| low-energy high-protein diet intervention | Experimental | Behavioral: Low-Energy High-Protein DietParticipants in this single-arm study will undergo a 12-week low-energy high-protein diet intervention (personalized nutritional counseling by a dietitian). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Energy High-Protein DietThis 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. | Behavioural | low-energy high-protein diet intervention |
Primary outcome
Change in Body Weight
Time frame: 12 weeks
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)
5 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: 12 weeks
Change in Fat Mass
Time frame: 12 weeks
Change in Muscle Mass
Time frame: 12 weeks
Change in Visceral Fat
Time frame: 12 weeks
Change in Waist Circumference
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient privacy and confidentiality, in accordance with the informed consent signed by the participants and the restrictions set by the Institutional Review Board (IRB) / Ethics Committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Energy High-Protein Diet in people with Obesity, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yovita Puri Subardjo, S.Gz., Dietisien, MPH (+628174100488, yovitapurisubardjo@mail.ugm.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.