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

February 25, 2021 updated by: Etika Ratna Noer, Universitas Diponegoro

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Central Java
      • Semarang, Central Java, Indonesia, 50275
        • Etika Ratna Noer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

healthy woman obese and pre menopause

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 1
interleukin-6
Time Frame: day 1
plasma IL-6 was determined by enzyme-linked immunosorbent method (EliKine™ Human IL-6 ELISA Kit)
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Diponegoro

Investigators

  • Principal Investigator: Etika Noer, PhD, Diponegoro University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2020

Primary Completion (ACTUAL)

October 1, 2020

Study Completion (ACTUAL)

November 30, 2020

Study Registration Dates

First Submitted

February 1, 2021

First Submitted That Met QC Criteria

February 1, 2021

First Posted (ACTUAL)

February 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 2, 2021

Last Update Submitted That Met QC Criteria

February 25, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FTO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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