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Chronobiological Determinants of Gut Microbiome

NCT ID: NCT07303036

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-20

Study Completion Date

2019-06-21

Brief Summary

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The aim of this study is to examine how the number of daily eating occasions and the timing of energy intake influence gut microbiome composition in both morbidly obese and non-obese individuals. The analysis is based on baseline data from a case-control study involving 11 non-obese and 23 morbidly obese adults. Participants were excluded if they were younger than 19 or older than 65 years, had an acute or chronic inflammatory condition, had been diagnosed with an infectious disease, cancer, or alcohol dependence, or had used antibiotics within the three months prior to screening.

Detailed Description

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This study aimed to investigate how the number of daily eating occasions and the timing of energy intake influence gut microbiome composition in morbidly obese and non-obese adults. This case-control study examined the gut microbiota of 23 morbidly obese individuals (BMI \> 40 kg/m²) and 11 non-obese individuals (BMI \< 30 kg/m²).

Dietary intake was assessed using 24-hour dietary recall records. From these data, the number of meals, total daily energy intake, and the proportion of energy consumed within specific time intervals (06:00-13:00, 13:00-20:00, and 20:00-06:00) were calculated. Energy intake occurring after 20:00 was defined as nighttime eating.

Participant eligibility required individuals to be between 19 and 65 years of age, free from acute or chronic inflammatory diseases, and without diagnoses of infectious diseases, cancer, or alcohol addiction. Additionally, participants were excluded if they had taken antibiotics within the three months preceding the screening.

Conditions

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Morbid Obesity

Keywords

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morbid obesity chrononutrition dietary intake

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Morbidly obese

People who are classified as morbidly obese (BMI\>40 kg/m2)

No interventions assigned to this group

Non-obese

People who are classified as non-obese (BMI\<30 kg/m2)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Adults aged 19 to 65 years Morbid obesity (case group) Non-obese status, including lean or pre-obese (control group) Willingness to participate in the study Ability to provide informed consent

Exclusion Criteria

Age \< 26 years or \> 60 years Presence of acute or chronic inflammatory diseases Diagnosis of infectious diseases History of cancer Alcohol addiction Use of antibiotics within 3 months prior to screening
Minimum Eligible Age

26 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Aslihan Ozdemir

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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GO 23/450

Identifier Type: -

Identifier Source: org_study_id