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 sierpnia 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
29
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Yovita Puri Subardjo, S.Gz., Dietisien, MPH
- Numer telefonu: +628174100488
- E-mail: yovitapurisubardjo@mail.ugm.ac.id
Lokalizacje studiów
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Central Java
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Banyumas, Central Java, Indonezja, 53122
- Integrated Health Science Building, Faculty of Health Sciences
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Kontakt:
- Adendita Azmi Afiattami, S.Gz
- Numer telefonu: +6285117481147
- E-mail: adendita.azmi@unsoed.ac.id
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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).
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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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Body Weight
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Body Mass Index (BMI)
Ramy czasowe: 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
Ramy czasowe: 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
|
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Change in Muscle Mass
Ramy czasowe: 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
|
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Change in Visceral Fat
Ramy czasowe: 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
|
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Change in Waist Circumference
Ramy czasowe: 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)
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12 weeks
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Fasting Serum Triglycerides
Ramy czasowe: 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)
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12 weeks
|
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Change in Fasting Serum High-Density Lipoprotein (HDL) Cholesterol
Ramy czasowe: 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)
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12 weeks
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Change in Fasting Serum Low-Density Lipoprotein (LDL) Cholesterol
Ramy czasowe: 12 weeks
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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)
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12 weeks
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Change in Fasting Serum Total Cholesterol
Ramy czasowe: 12 weeks
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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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12 weeks
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Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Ramy czasowe: 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)
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12 weeks
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Współpracownicy i badacze
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Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 września 2026
Zakończenie podstawowe (Szacowany)
31 grudnia 2026
Ukończenie studiów (Szacowany)
31 stycznia 2027
Daty rejestracji na studia
Pierwszy przesłany
7 sierpnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
7 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
12 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
13 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
11 sierpnia 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 092/KEPK/PE/VII/2026 (Inny identyfikator: Health Research Ethics Committee, Faculty of Medicine, Universitas Jenderal Soedirman)
- 202406210804017 (Inny numer grantu/finansowania: Indonesia Endowment Fund for Education Agency (LPDP RI))
- 548/UN1/FKKMK.3/S3KK.3/PJ/2026 (Inny identyfikator: Doctoral Program in Medical and Health Sciences, Faculty of Medicine, Public Health, and Nursing UGM)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu 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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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