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OpenTrials
Completed

NCT Number: NCT04740528

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

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

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Key information

Conditions

Age range

35 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Etika Ratna Noer

Semarang, Central Java, 50275, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

fto gene testing

Diagnostic Test

Blood samples were collected after a 12-h fasting by Prodia Laboratory for DNA isolation and biochemical analysis

Primary outcomes

  1. fto gene rs 1558902

    Time frame: day 1

    Genomic DNA was extracted from 300 ml of buffy coat using spin colomn method. rs 1558902 were genotyped using TaqMan probes C__30090620_10

  2. interleukin-6

    Time frame: day 1

    plasma IL-6 was determined by enzyme-linked immunosorbent method (EliKine™ Human IL-6 ELISA Kit)

Sponsors and collaborators

Lead sponsor

Universitas Diponegoro

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2021
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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