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

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Other: Mobile app

• Registration Number: NCT04850391
• Lead Sponsor: Turku University Hospital

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.

Study Timeline

• Study First Submitted: 2021-04-09
• Study First Submitted QC: 2021-04-14
• Study First Posted: 2021-04-20
• Study Start: 2021-10-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-16
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obese OSA	Mobile app	OSAS patients with BMI \> 30 kg/m2
Lean-overweight	Mobile app	BMI 18.5 - 30 kg/m2
Obese	Mobile app	BMI \> 30 kg/m2

Primary Outcome Measures

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

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland