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

Obesity Clinical Trial

— ObeApp  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04850391
• Other study ID #: ObeApp
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 2025

Study information

• Verified date: June 2022
• Source: Turku University Hospital
• Contact: Tarja Saaresranta, MD, PhD
• Phone: +35823130000
• Email: tasaare[@]utu.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Mobile app
To compare changes induced by the movile app intervention among the three study groups

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

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