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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)

2026年8月11日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

29

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 印度尼西亚
    • Central Java
      • Banyumas、Central Java、印度尼西亚、53122
        • Integrated Health Science Building, Faculty of Health Sciences
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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).
行为的：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Body Weight
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Change in Body Mass Index (BMI)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Change in Fasting Serum Triglycerides
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Gadjah Mada University

合作者

Universitas Jenderal Soedirman
Faculty of Medicine, Gadjah Mada University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年1月31日

研究注册日期

首次提交

2026年8月7日

首先提交符合 QC 标准的

2026年8月7日

首次发布 (实际的)

2026年8月12日

研究记录更新

最后更新发布 (实际的)

2026年8月13日

上次提交的符合 QC 标准的更新

2026年8月11日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 092/KEPK/PE/VII/2026 (其他标识符：Health Research Ethics Committee, Faculty of Medicine, Universitas Jenderal Soedirman)
  • 202406210804017 (其他赠款/资助编号：Indonesia Endowment Fund for Education Agency (LPDP RI))
  • 548/UN1/FKKMK.3/S3KK.3/PJ/2026 (其他标识符：Doctoral Program in Medical and Health Sciences, Faculty of Medicine, Public Health, and Nursing UGM)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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