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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 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

29

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Indonésie
    • Central Java
      • Banyumas, Central Java, Indonésie, 53122
        • Integrated Health Science Building, Faculty of Health Sciences
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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).
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Body Weight
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Body Mass Index (BMI)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Change in Fasting Serum Triglycerides
Délai: 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
Délai: 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
Délai: 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
Change in Fasting Serum Total Cholesterol
Délai: 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
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Délai: 12 weeks
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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Gadjah Mada University

Collaborateurs

Universitas Jenderal Soedirman
Faculty of Medicine, Gadjah Mada University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

31 décembre 2026

Achèvement de l'étude (Estimé)

31 janvier 2027

Dates d'inscription aux études

Première soumission

7 août 2026

Première soumission répondant aux critères de contrôle qualité

7 août 2026

Première publication (Réel)

12 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 092/KEPK/PE/VII/2026 (Autre identifiant: Health Research Ethics Committee, Faculty of Medicine, Universitas Jenderal Soedirman)
  • 202406210804017 (Autre subvention/numéro de financement: Indonesia Endowment Fund for Education Agency (LPDP RI))
  • 548/UN1/FKKMK.3/S3KK.3/PJ/2026 (Autre identifiant: Doctoral Program in Medical and Health Sciences, Faculty of Medicine, Public Health, and Nursing UGM)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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