Clinical trial NCT06442202: Balanced Nutritional Diet Intervention Among Obese Women
Official title: Balanced Nutritional Diet Intervention on Body Composition Among Different FTO RS9939609 Gene in Obese Young Women In Bandung, Indonesia: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese Women
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Food intake along with the gene are important factors that influence human nutrition status and health. Indonesia has a balanced nutrition diet guide for ideal food consumption. The FTO rs9939609 gene is known to be related to obesity. This study aimed to examine the effect of a balanced nutritional diet intervention on body composition among different single nucleotide polymorphisms (SNP) of the FTO rs9939609 gene in obese young women in Bandung City, West Java, Indonesia.

Detailed description: A Balanced Nutrition Diet is a group of food menus that contain carbohydrates, fats, proteins, vitamins and minerals which are prepared based on the principles of diversity, balanced, regular and safe proportions in types and quantities that suit the body's needs adapted from the My Meal Dish Content/"Isi Piringku"; and "Tumpeng Gizi Seimbang" rule based on the Balanced Nutrition Guidelines of the Republic of Indonesia Minister of Health Regulation No. 41 year 2014. Although a balanced nutritional diet has not been widely used as a dietary intervention for obese people compared to the Mediterranean diet, there is research that shows that providing a low-calorie balanced nutritional diet based on traditional Indonesian food for 8 weeks can reduce body weight and body mass index, waist circumference, and body fat percentage of the research subjects were statistically significant.

Apart from eating habits, genetic factors also play an important role in the development of obesity. One of the most important genes associated with obesity is the FTO (fat mass and obesity-related) gene located on chromosome 16. Several polymorphisms in the FTO gene are known to be associated with increased body mass index (BMI) and other anthropometric values, severe obesity conditions, and risk of diabetes mellitus, although there are differences in different ethnicities. Several studies have also examined the association of the FTO gene with several parameters related to cardiovascular risk. The FTO rs9939609 gene polymorphism is one of the genes commonly studied in relation to obesity. The rs9939609 FTO gene consists of TT, TA, and AA genotypes. Allele A is a group of mutant genotypes or is called a risk allele (TA and AA) while TT is a group of wild genotypes or is considered a non-risk allele.

Evidence suggests that compared with TT wild type, the risk allele A FTO rs9939609 gene showed significantly higher body weight, body mass index, waist circumference, hip circumference, and waist-to-hip ratio. The waist-hip circumference ratio is a stronger indicator of cardiovascular disease than body mass index. The A allele carriers of the FTO rs9939609 polymorphism had a higher fat percentage. Until now, no one has ever linked the FTO gene polymorphism and the Balanced Nutrition Diet intervention, which is a reference in Indonesia, as well as its effect on the body composition of obese young women, especially in Sundanese ethnicity. This study aimed to examine the effect of a balanced nutritional diet intervention on body composition among 2 types of the FTO rs9939609 gene in obese young women in Bandung City, Indonesia.

Eligibility criteria: Inclusion Criteria:

* Obese women (fat percentage\>35%) who had light to moderate physical activity based on PAL or who rarely exercised
* Sundanese ethnicity
* Aged 18-25 years
* Normal fasting blood glucose levels
* Willing to participate and sign an informed consent

Exclusion Criteria:

* Being pregnant and breastfeeding
* Had a history of chronic disease
* Regularly consuming antioxidant supplements and/or phytopharmaceuticals
* Currently participating in other research

Primary outcomes:
measure: Change of Body Compostition
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bogor
country: Indonesia
facility: Prodi Gizi IPB
Study officials:
affiliation: Institut Pertanian Bogor
name: Prodi Gizi
role: PRINCIPAL_INVESTIGATOR
References: