Time-restricted Eating and High-intensity Interval Training for Long-term Improvement in Metabolic Health
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Total fat mass
Study Overview
Brief Summary
This study will investigate the effects of 12 months periodised time-restricted eating combined with high-intensity interval training compared with a control group on fat mass in adults with overweight/obesity. Participants in the intervention group will complete the intervention remotely and will receive follow-up by telephone. Before randomisation, after 6 months and after 12 months, 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control
No intervention or follow-up. Habitual lifestyle
Time-restricted eating and high-intensity interval training
12 months of periodised time-restricted eating and high-intensity interval training with digital follow-up
Intervention: Time-restricted eating and high-intensity interval training (Behavioral)
Outcomes
Primary Outcomes
Total fat mass
Time Frame: From baseline to after 12 months
Change in total fat mass measured with bioelectrical impedance analysis
Secondary Outcomes
- Fat-free mass(From baseline to after 6 months and after 12 months)
- Diet intake(During baseline week, after 4, 13, 30, and 50 weeks.)
- Sleep quality(From baseline to after 6 months and after 12 months)
- Diastolic blood pressure(From baseline to after 6 months and after 12 months)
- Resting heart rate(From baseline to after 6 months and after 12 months)
- Physical activity levels(From baseline to after 6 months and after 12 months)
- Blood glucose(From baseline to after 6 months and after 12 months)
- Total fat mass(From baseline to after 6 months)
- Insulin(From baseline to after 6 months and after 12 months)
- Average glucose levels(From baseline to after 6 months and after 12 months)
- Blood cholesterol(From baseline to after 6 months and after 12 months)
- LDL-cholesterol(From baseline to after 6 months and after 12 months)
- HDL-cholesterol(From baseline to after 6 months and after 12 months)
- Triglycerides(From baseline to after 6 months and after 12 months)
- Cardiorespiratory fitness(From baseline to after 6 months and after 12 months)
- Insulin sensitivity(From baseline to after 6 months and after 12 months)
- Body mass(From baseline to after 6 months and after 12 months)
- Visceral fat area(From baseline to after 6 months and after 12 months)
- Systolic blood pressure(From baseline to after 6 months and after 12 months)