Chronobiological Determinants of Gut Microbiome

NCT07303036 | Completed

• 1 other identifier: GO 23/450
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Morbid Obesity

Keywords

morbid obesity; chrononutrition; dietary intake

Outcome Measures

Primary Outcomes (4)

• Gut microbial profiles of participants

  Gut microbial profiles of participants at phylum and sub-phylum levels

  Baseline

• Meal frequency of participants

  Number of meals consumed per day

  Baseline

• Total daily energy intake

  Total daily energy intake assessed from dietary data (kcal/day)

  Baseline

• Distribution of energy intake by time of day

  Percentage of total daily energy intake consumed during predefined time periods of the day (e.g., morning, afternoon, evening, night)

  Baseline

Study Arms (2)

Morbidly obese

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

Non-obese

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

Eligibility Criteria

• Age: 26 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Study Population: Participants were recruited into three groups: Case group: 23 morbidly obese participants Control group: 11 non-obese participants, including lean (n=5) and pre-obese (n=6)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 24, 2025
• Study Start: October 20, 2016
• Primary Completion: January 1, 2018
• Study Completion: June 21, 2019
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)