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.
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.
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.
Single group
Low-Energy High-Protein Diet
BehavioralThis 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.
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)
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)
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)
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)
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)
Change in Fasting Serum Triglycerides
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)
Change in Fasting Serum High-Density Lipoprotein (HDL) Cholesterol
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)
Change in Fasting Serum Low-Density Lipoprotein (LDL) Cholesterol
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)
Change in Fasting Serum Total Cholesterol
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)
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Gadjah Mada University
Lead sponsor
Universitas Jenderal Soedirman
Collaborator
Faculty of Medicine, Gadjah Mada University
Collaborator
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