MedDataX Logo

Interaction of Sleep, Diurnal Eating Pattern, Gut Microbiota, and Obesity

NCT ID: NCT04850391

Last Updated: 2025-12-29

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2024-10-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goals of the proposed study are 1) to provide scientific basis for the relationship between subjective sleep quality, diurnal eating pattern, gut microbiome, and obesity, 2) to develop and test a pragmatic, cost-effective new tool to advance lifestyle changes using E-health approach, and 3) to compare differences in subjective sleep quality, diurnal eating pattern and gut microbiome at baseline 4) to compare changes induced by the E-health intervention among the three study groups and participants with different work schedules.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The data are fragmented and studies are focusing on interactions of sleep and obesity, eating pattern and obesity, or gut microbiota and obesity, but not the cross-talk of all these factors in the same individual or population. Therefore, we need a multifactorial approach to get a more deep insight on the obesity and weight regulation. Further, novel cost-effective tools to advance lifestyle changes are needed. Emerging evidence suggests that novel countermeasures, such as modulation of the timing of food intake, may be effective strategies in weight control and prevention of obesity. The goals of the proposed study are 1) to provide scientific basis for the relationship between subjective sleep quality, diurnal eating pattern, gut microbiome, and obesity, 2) to develop and test a pragmatic, cost-effective new tool to advance lifestyle changes using E-health approach, and 3) to compare differences in subjective sleep quality, diurnal eating pattern and gut microbiome at baseline 4) to compare changes induced by the E-health intervention among the three study groups and participants with different work schedules.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Obesity & Overweight

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

obesity eating window time-restricted eating sleep glucose balance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lean-overweight

BMI 18.5 - 30 kg/m2

Group Type ACTIVE_COMPARATOR

Mobile app

Intervention Type OTHER

To compare changes induced by the movile app intervention among the three study groups

Obese

BMI \> 30 kg/m2

Group Type ACTIVE_COMPARATOR

Mobile app

Intervention Type OTHER

To compare changes induced by the movile app intervention among the three study groups

Obese OSA

OSAS patients with BMI \> 30 kg/m2

Group Type ACTIVE_COMPARATOR

Mobile app

Intervention Type OTHER

To compare changes induced by the movile app intervention among the three study groups

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mobile app

To compare changes induced by the movile app intervention among the three study groups

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Community dwelling 18 - 65 year old adults
* BMI 18.5 - 30 kg/m2 (n = 40, M:F = 1:1)
* BMI \> 30 kg/m2 (n = 40, M:F = 1:1)
* OSAS patients with BMI \> 30 kg/m2 using nasal continuous positive airway pressure (CPAP) treatment on an average \> 4 h/d (n = 40, M:F = 1:1).

Exclusion Criteria

* Antimicrobial treatment within 3 months prior the baseline visit
* Inflammatory bowel diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Helsinki

OTHER

Sponsor Role collaborator

University of Turku

OTHER

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tarja Saaresranta

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tarja Saaresranta, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Turku University Hospital

Turku, , Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ObeApp

Identifier Type: -

Identifier Source: org_study_id