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Completed

NCT Number: NCT04850391

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

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Key information

Conditions

Obesity Behavior Body Weight Fasting Feeding Behavior Intermittent Fasting Nutrition Disorders Nutritional and Metabolic Diseases Obesity & Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turku University Hospital

Turku, 20521, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile app

Other

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

Primary outcomes

  1. Weight

    Time frame: 2 years

    Changes in weight

  2. Waist/Hip ratio

    Time frame: 2 years

    Changes in Waist/Hip ratio

  3. Change in Blood Pressure

    Time frame: 2 years

    Change in Blood Pressure

  4. GHbA1c

    Time frame: 2 years

    Change in GHbA1c

  5. Gut microbiota

    Time frame: 2 years

    Changes in gut microbiota (species, proportions of different species)

  6. Timing of eating

    Time frame: 2 years

    Change in timing of eating

  7. Subjective sleep quality (Pittsburg Sleep Quality Index)

    Time frame: 2 years

    Changes in subjective sleep quality

  8. Excessive daytime sleepiness (Epworth Sleepiness Scale)

    Time frame: 2 years

    Change in excessive daytime sleepiness

  9. Mood (DEPS questionnaire)

    Time frame: 2 years

    Changes in mood

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • University of Helsinki
  • University of Turku

Registry information

Acronym: ObeApp

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 20, 2021
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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