NCT04740528

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

February 1, 2021

Last Update Submit

February 25, 2021

Conditions

Keywords

woman Obesefto-genrs1558902protein intake

Outcome Measures

Primary Outcomes (2)

  • 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

  • interleukin-6

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

    day 1

Interventions

fto gene testingDIAGNOSTIC_TEST

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

Eligibility Criteria

Age35 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

healthy woman obese and pre menopause

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etika Ratna Noer

Semarang, Central Java, 50275, Indonesia

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood specimen intravenous 5ml

Study Officials

  • Etika Noer, PhD

    Diponegoro University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Nutrition, Medical Faculty

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 5, 2021

Study Start

August 1, 2020

Primary Completion

October 1, 2020

Study Completion

November 30, 2020

Last Updated

March 2, 2021

Record last verified: 2021-02

Locations