Interaction of Sleep, Diurnal Eating Pattern, Gut Microbi... | NCT04850391

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

NCT04850391

Sponsor

Turku University Hospital

Status

Completed

Last Update Posted

Dec 29, 2025Actual

Enrollment

133Actual

Phase

Not Applicable

Conditions

Obesity
Obesity & Overweight

Interventions

Mobile app

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2021Actual

Primary Completion Date

Oct 21, 2024Actual

Completion Date

Oct 21, 2024Actual

First Submitted Date

Apr 9, 2021

First Submission Date that Met QC Criteria

Apr 14, 2021

First Posted Date

Apr 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2025

Last Update Posted Date

Dec 29, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tarja Saaresranta, Principal Investigator, Turku University HospitalPrincipal Investigator

Lead Sponsor

Turku University HospitalOTHER_GOV

Collaborators

Name	Class
University of Helsinki	OTHER
University of Turku	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

133Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lean-overweight	Active Comparator	BMI 18.5 - 30 kg/m2	Other: Mobile app
Obese	Active Comparator	BMI > 30 kg/m2	Other: Mobile app
Obese OSA	Active Comparator	OSAS patients with BMI > 30 kg/m2	Other: Mobile app

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mobile app	Other	To compare changes induced by the movile app intervention among the three study groups	Lean-overweight Obese Obese OSA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight	Changes in weight	2 years
Waist/Hip ratio	Changes in Waist/Hip ratio	2 years
Change in Blood Pressure	Change in Blood Pressure	2 years
GHbA1c	Change in GHbA1c	2 years
Gut microbiota	Changes in gut microbiota (species, proportions of different species)	2 years
Timing of eating	Change in timing of eating	2 years
Subjective sleep quality (Pittsburg Sleep Quality Index)	Changes in subjective sleep quality	2 years
Excessive daytime sleepiness (Epworth Sleepiness Scale)	Change in excessive daytime sleepiness	2 years
Mood (DEPS questionnaire)	Changes in mood	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tarja Saaresranta, MD, PhD	Turku University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Turku University Hospital		Turku		20521	Finland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D050177	Overweight
D000093763	Intermittent Fasting

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided