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Chronobiological Determinants of Gut Microbiome (ChronoNutr)

H

Hacettepe University

Status

Completed

Conditions

Morbid Obesity

Study type

Observational

Funder types

Other

Identifiers

NCT07303036
GO 23/450

Details and patient eligibility

About

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.

Full description

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.

Enrollment

34 patients

Sex

All

Ages

26 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

34 participants in 2 patient groups

Morbidly obese
Description:
People who are classified as morbidly obese (BMI\>40 kg/m2)
Non-obese
Description:
People who are classified as non-obese (BMI\<30 kg/m2)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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