Clinical trial NCT05505305: Time-restricted Eating and Interval Training With Digital Follow-up
Official title: Effects of Time-restricted Eating and Interval Training With Digital Follow-up: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: time-restricted eating
high-intensity interval training
exercise
diet
body composition
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the effects of seven weeks of time-restricted eating combined with high-intensity interval training compared with a control group on body composition in adults with overweight/obesity. Participants in the intervention group will complete the intervention remotely and will receive weekly follow-up through online platforms (telephone, video call). Before and after the intervention, the investigators will measure the participants' body composition, physical fitness, fasting blood glucose and insulin, blood lipids, and blood pressure. Physical activity, diet, sleep quality, appetite, and adherence to the intervention will also be measured. Secondary sub-analyses of sex differences in the responses to the intervention will be performed.


Eligibility criteria: Inclusion Criteria:

* Body mass index ≥ 27 kg/m²
* Able to walk or ride a bike \> 60 min

Exclusion Criteria:

* On-going pregnancy
* Lactation within 24 weeks of study commencement
* High-intensity exercise ≥ 1/week
* Habitual eating window ≤12 hours/day
* Taking hypertension, glucose-, or lipid-lowering drugs
* Body mass variation ≥ 4 kg three months prior to study commencement
* Known diabetes mellitus (type 1 or 2) or cardiovascular disease
* Working night shifts

Primary outcomes:
measure: Total fat mass
timeFrame: From baseline to after 7 weeks of intervention
Secondary outcomes:
measure: Blood glucose
timeFrame: From baseline to after 7 weeks of intervention
measure: Insulin
timeFrame: From baseline to after 7 weeks of intervention
measure: Average glucose levels
timeFrame: From baseline to after 7 weeks of intervention
measure: Blood Cholesterol
timeFrame: From baseline to after 7 weeks of intervention
measure: HDL-cholesterol in blood
timeFrame: From baseline to after 7 weeks of intervention
measure: LDL-cholesterol in blood
timeFrame: From baseline to after 7 weeks of intervention
measure: Triglycerides in blood
timeFrame: From baseline to after 7 weeks of intervention
measure: Insulin sensitivity
timeFrame: From baseline to after 7 weeks of intervention
measure: Cardiorespiratory fitness
timeFrame: From baseline to after 7 weeks of intervention
measure: Body mass
timeFrame: From baseline to after 7 weeks of intervention
measure: Body fat-free mass
timeFrame: From baseline to after 7 weeks of intervention
measure: Visceral fat area
timeFrame: From baseline to after 7 weeks of intervention
measure: Systolic blood pressure
timeFrame: From baseline to after 7 weeks of intervention
measure: Diastolic blood pressure
timeFrame: From baseline to after 7 weeks of intervention
measure: Resting heart rate
timeFrame: From baseline to after 7 weeks of intervention
measure: Physical activity level
timeFrame: From baseline to after 7 weeks of intervention
measure: Self-reported physical activity
timeFrame: 7 days at baseline, 7 days at start of intervention, 7 days at end of intervention.
measure: Diet intake
timeFrame: 7 days at baseline, 7 days at start of intervention, 7 days at end of intervention.
measure: Sleep quality
timeFrame: From baseline to after 7 weeks of intervention
measure: Sleep duration
timeFrame: 7 days at baseline, 7 days at start of intervention, 7 days at end of intervention
measure: Appetite
timeFrame: 7 days at baseline, 7 days at start of intervention, 7 days at end of intervention
Other outcomes:
measure: Adherence to high-intensity interval training
timeFrame: Seven weeks
measure: Compliance to high-intensity interval training
timeFrame: Seven weeks
measure: Adherence to time-restricted eating
timeFrame: Seven weeks
measure: Compliance to time-restricted eating
timeFrame: Seven weeks
measure: Perception of intervention and digital follow-up
timeFrame: After seven weeks of intervention
measure: Sex differences
timeFrame: From baseline to after 7 weeks of intervention
Locations:
city: Trondheim
country: Norway
facility: Department of circulation and medical imaging, NTNU
Study officials:
affiliation: Norwegian University of Science and Technology, Trondheim, Norway
name: Øivind Rognmo, PhD
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology, Trondheim, Norway
name: Trine Moholdt, PhD
role: PRINCIPAL_INVESTIGATOR
References: