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 (Gens-HiPro)
11 augustus 2026 bijgewerkt door: Yovita Puri Subardjo, Gadjah Mada University
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
29
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Yovita Puri Subardjo, S.Gz., Dietisien, MPH
- Telefoonnummer: +628174100488
- E-mail: yovitapurisubardjo@mail.ugm.ac.id
Studie Locaties
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Central Java
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Banyumas, Central Java, Indonesië, 53122
- Integrated Health Science Building, Faculty of Health Sciences
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Contact:
- Adendita Azmi Afiattami, S.Gz
- Telefoonnummer: +6285117481147
- E-mail: adendita.azmi@unsoed.ac.id
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: low-energy high-protein diet intervention
Participants in this single-arm study will undergo a 12-week low-energy high-protein diet intervention (personalized nutritional counseling by a dietitian).
|
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Body Weight
Tijdsspanne: 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)
|
12 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Body Mass Index (BMI)
Tijdsspanne: 12 weeks
|
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)
|
12 weeks
|
|
Change in Fat Mass
Tijdsspanne: 12 weeks
|
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)
|
12 weeks
|
|
Change in Muscle Mass
Tijdsspanne: 12 weeks
|
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)
|
12 weeks
|
|
Change in Visceral Fat
Tijdsspanne: 12 weeks
|
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)
|
12 weeks
|
|
Change in Waist Circumference
Tijdsspanne: 12 weeks
|
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)
|
12 weeks
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Fasting Serum Triglycerides
Tijdsspanne: 12 weeks
|
Triglycerides refer to triacylglycerol molecules, measured via biochemical analysis of blood after a minimum 8-hour fast and reported in mg/dL.
The change in triglyceride values is calculated as the difference between the triglyceride value at the baseline of the intervention (Week 0) and the end of the intervention (Week 12).
(Scale: Ratio)
|
12 weeks
|
|
Change in Fasting Serum High-Density Lipoprotein (HDL) Cholesterol
Tijdsspanne: 12 weeks
|
HDL refers to small plasma lipoprotein particles, measured via biochemical analysis of blood after a minimum 8-hour fast and reported in mg/dL.
The change in HDL values is calculated as the difference between the HDL value at the baseline of the intervention (Week 0) and the end of the intervention (Week 12).
(Scale: Ratio)
|
12 weeks
|
|
Change in Fasting Serum Low-Density Lipoprotein (LDL) Cholesterol
Tijdsspanne: 12 weeks
|
LDL refers to low-density plasma lipoprotein particles, measured via biochemical analysis of blood after a minimum 8-hour fast and reported in mg/dL.
The change in LDL values is calculated as the difference between the LDL value at the baseline of the intervention (Week 0) and the end of the intervention (Week 12).
(Note: Fixed a typo in your original text which stated "nilai HDL pada awal intervensi").
(Scale: Ratio)
|
12 weeks
|
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Change in Fasting Serum Total Cholesterol
Tijdsspanne: 12 weeks
|
Total cholesterol is the concentration of all cholesterol contained within the lipoproteins circulating in the blood, measured enzymatically in serum/plasma and reported in mg/dL.
The change in total cholesterol values is calculated as the difference between the total cholesterol value at the baseline of the intervention (Week 0) and the end of the intervention (Week 12).
(Scale: Ratio)
|
12 weeks
|
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Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Tijdsspanne: 12 weeks
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CRP is the measured concentration of an acute-phase protein produced by the liver in response to inflammatory cytokines, measured using a standard hs-CRP assay and reported in mg/dL.
The change in CRP values is calculated as the difference between the CRP value at the baseline of the intervention (Week 0) and the end of the intervention (Week 12).
(Scale: Ratio)
|
12 weeks
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 september 2026
Primaire voltooiing (Geschat)
31 december 2026
Studie voltooiing (Geschat)
31 januari 2027
Studieregistratiedata
Eerst ingediend
7 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
7 augustus 2026
Eerst geplaatst (Werkelijk)
12 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
11 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 092/KEPK/PE/VII/2026 (Andere identificatie: Health Research Ethics Committee, Faculty of Medicine, Universitas Jenderal Soedirman)
- 202406210804017 (Ander subsidie-/financieringsnummer: Indonesia Endowment Fund for Education Agency (LPDP RI))
- 548/UN1/FKKMK.3/S3KK.3/PJ/2026 (Andere identificatie: Doctoral Program in Medical and Health Sciences, Faculty of Medicine, Public Health, and Nursing UGM)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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