Clinical trial NCT04850391: Interaction of Sleep, Diurnal Eating Pattern, Gut Microbiota, and Obesity
Official title: Interaction of Sleep, Diurnal Eating Pattern, Gut Microbiota, and Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2021-04-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Weight
timeFrame: 2 years
measure: Waist/Hip ratio
timeFrame: 2 years
measure: Change in Blood Pressure
timeFrame: 2 years
measure: GHbA1c
timeFrame: 2 years
measure: Gut microbiota
timeFrame: 2 years
measure: Timing of eating
timeFrame: 2 years
measure: Subjective sleep quality (Pittsburg Sleep Quality Index)
timeFrame: 2 years
measure: Excessive daytime sleepiness (Epworth Sleepiness Scale)
timeFrame: 2 years
measure: Mood (DEPS questionnaire)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Tarja Saaresranta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: