Preference of Protein Intake and FTO rs1558902 Gene Polymorphism Among Women Obese

Obesity Adult Onset Clinical Trial

Official title:

Department of Nutrition Science, Medical Faculty, Universitas Diponegoro Semarang, Indonesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04740528
• Other study ID #: FTO
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2021
• Source: Universitas Diponegoro
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The concept personalized gene-based nutrition combines genetic information with specific dietary intake that is crucial in managing obesity. Obesity experienced by adult women is generally caused by inapproriate diet and sedentary lifestyle. Variations in the fat mass and obesity-related gene (FTO) has been linked with susceptibility to obesity, but diet seems to change the relationship. A single nucleotide polymorphism (SNP) in the fat mass and obesity-associated gene (FTO) is a potent predictor of human obesity. Higher protein diets were more appropriate than standard protein diets, and frequently recommended as a weight loss plan as it prevents the loss of lean tissue mass. Nevertheless, high intakes of proteins may adversely affect metabolic functions. Multi studies have explored associated FTO polymorphisms with obesity in different populations. However, the contribution of the FTO common variants to obesity is controversial in Asian people, some studies showed rs1558902 was statistically associated with BMI, but other results reported FTO gene is not statistically associated with obesity. Given the diversity of Asian populations, the investigators generated a hypothesis whether relations between preference protein intake and FTO rs1558902 gene polymorphism exist in selected Indonesian obesity women

Description:

The sample size was calculated based on the difference in the proportion of variation of the gene FTO rs1558902 allele A between obese participants, which previous study estimated to be approximately 6% for populations from Malaysia. Using a power of 80% and a level of significance of 5%, the investigators required 100 obese participants. BMI and body fat which were assessed by SECA body analyzer (SECA 201). Blood samples were collected after a 12-h minimum fast by Prodia Laboratory for DNA isolation and biochemical analysis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 30, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 45 Years

Eligibility

Inclusion Criteria:

• Body Mass index > 25 kg/m2
• waist circumference > 80 cm

Exclusion Criteria:

• chronic disease
• have pregnancy
• consume diet supplement, drugs

Related Conditions & MeSH terms

• Obesity Adult Onset

Intervention

Diagnostic Test:
• fto gene testing
Blood samples were collected after a 12-h fasting by Prodia Laboratory for DNA isolation and biochemical analysis

Locations

Country	Name	City	State
Indonesia	Etika Ratna Noer	Semarang	Central Java

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Diponegoro

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fto gene rs 1558902	Genomic DNA was extracted from 300 ml of buffy coat using spin colomn method. rs 1558902 were genotyped using TaqMan probes C__30090620_10	day 1
Primary	interleukin-6	plasma IL-6 was determined by enzyme-linked immunosorbent method (EliKine™ Human IL-6 ELISA Kit)	day 1