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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Change in Body Weight
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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).
Intervention: Low-Energy High-Protein Diet (Behavioral)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Change in Body Mass Index (BMI)(12 weeks)
- Change in Fat Mass(12 weeks)
- Change in Muscle Mass(12 weeks)
- Change in Visceral Fat(12 weeks)
- Change in Waist Circumference(12 weeks)
Investigators
Yovita Puri Subardjo
PhD student and as a Dietisien
Gadjah Mada University