Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06442202 |
| Other study ID # |
IPB-202405.01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 8, 2023 |
| Est. completion date |
January 15, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
Universitas Padjadjaran |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
