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

NCT04850391 | Completed

• 1 other identifier: ObeApp
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Obesity & Overweight

Keywords

obesity; eating window; time-restricted eating; sleep; glucose balance

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (3)

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

Mobile app OTHER

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

Lean-overweight; Obese; Obese OSA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Antimicrobial treatment within 3 months prior the baseline visit
• Inflammatory bowel diseases

Sponsors & Collaborators

• Turku University Hospital: lead
• University of Helsinki: collaborator
• University of Turku: collaborator

Study Sites (1)

Turku University Hospital

Turku, 20521, Finland

Location

MeSH Terms

Conditions

Obesity; Overweight; Intermittent Fasting

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Study Officials

• Tarja Saaresranta, MD, PhD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 20, 2021
• Study Start: October 1, 2021
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

FI (1)