NCT05664321

Brief Summary

People who are overweight are getting more and more common in every region of the world. However, despite significant progress being made in the treatment options available for overweight, the worldwide incidence of overweight has not gone down, and the challenge of overweight has become a worrisome phenomenon of our times. Additionally, the process that underlie this illness and the etiological variables are not fully comprehended. As a result, it is absolutely necessary to determine the factors that contribute to obesity and define the responsibilities that each play. Researchers have devoted a significant portion of the better part of the last decade to studying the microbiota of the gut to determine whether or not it may play a factor in the development of obesity. Across spite of this, there is a paucity of accessible epidemiological data in Saudi Arabia. In addition, the relationship between the composition of the "gut microbiota" and obesity indices in youthful women of reproductive age is little understood. In view of this, we decided to conduct a case study utilizing whole-genome shotgun sequencing to compare the gut microbiota of obese women from Saudi Arabia with that of healthy control participants. Our findings shed light on the significance of the gut microbiota in obesity and provide useful insight into the creation of a method for the therapy of obesity by means of microbiota transfer of fecal, antibiotics, probiotics, and prebiotics. In addition, these data reveal prospective targets for guiding the selection of probiotic strains for the needed gut microbiota regulation in the obesity therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 14, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 23, 2022

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

1.2 years

First QC Date

December 14, 2022

Last Update Submit

December 22, 2022

Conditions

Keywords

gut microbiotadietinflammatory markers

Outcome Measures

Primary Outcomes (1)

  • Correlations between gut flora by type of meat intake in total participants

    cross-sectional analysis

    Baseline

Study Arms (2)

Normal weight

Body mass index (BMI) between 18.50 and 24.99 kilograms per square meter

Other: Observational, case-control study

Obese

Body mass index (BMI) of more than 30 kilograms per square meter

Other: Observational, case-control study

Interventions

obese \[(BMI ≥30 kg/m2), (n=44)\], and non-obese \[(BMI= 18.50-24.99 kg/m2), (n=48)\].

Also known as: Obese and normal weight
Normal weightObese

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

92 Saudi female students aged (18 to 25 years), classified into; obese \[(BMI ≥30 kg/m2), (n=44)\], and non-obese \[(BMI= 18.50-24.99 kg/m2), (n=48)\].

You may qualify if:

  • Females
  • to 25 years of age
  • Normal weight: body mass index (BMI): 18.00-24.99 kg/m2
  • Obese: BMI ≥ 30 kg/m2

You may not qualify if:

  • Less than 18 years old or above 25 years
  • Overweight (BMI); 25.0-29.9 kg/m2)
  • Pregnant
  • Following specific diets (e.g., calorie-restricted diets)
  • Reported the presence of gastrointestinal diseases in the past eight weeks
  • Endocrine or oncological disease history, psychiatric disorders, anorexia, other medical conditions
  • Usage of multi-vitamins or vitamin B12 and antibiotics in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghadeer Aljuraiban

Riyadh, 12444, Saudi Arabia

Location

Biospecimen

Retention: SAMPLES WITH DNA

the DNA was extracted from 0.25 g frozen stool aliquots by the QIAGEN PowerFecal DNA Kit (Catalogue: 12830-50). The purity of the isolated DNA (260/280 ratio) and concentration was measured utilizing a NanoDrop spectrophotometer (Thermo Fisher Scientific, Waltham, MA, USA).

MeSH Terms

Conditions

ObesityMetabolic Syndrome

Interventions

Case-Control StudiesAdiposity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthBody Fat DistributionBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisBody CompositionBiochemical PhenomenaChemical PhenomenaMetabolismPhysiological Phenomena

Study Officials

  • Ghadeer Aljuraiban, PhD

    KSU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 14, 2022

First Posted

December 23, 2022

Study Start

January 1, 2019

Primary Completion

March 1, 2020

Study Completion

December 1, 2021

Last Updated

December 23, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Collaborations are welcomed upon contacting the corresponding author

Locations