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Recruiting NCT07036562

Time-restricted Eating and High-intensity Interval Training for Metabolic Health in Adults With Overweight/Obesity

No phase Interventional Overweight and Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Time-restricted eating and high-intensity interval training.
Who it may be relevant to
Registry conditions: Overweight and Obesity. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Time-restricted Eating and High-intensity Interval Training for Long-term Improvement in Metabolic Health

Overview

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.

Interventions

  • Behavioral Time-restricted eating and high-intensity interval training
    1-month intense periods of maximal daily eating window of 10 hours and high-intensity interval training (three weekly, unsupervised, aerobic exercise sessions performed at \> 90 % heart rate maximum), separated by 3-month maintenance periods of time-restricted eating on 5 days per week and minimum 1 HIIT session per week. Each exercise session will last for 33-38 minutes. Participants will receive digital follow-up once weekly during intense periods, and once monthly during maintenance periods.

Primary outcome measures

  • Total fat mass [Time frame: From baseline to after 12 months]
Secondary outcome measures (12)
  • Blood glucose [Time frame: From baseline to after 6 months and after 12 months]
  • Total fat mass [Time frame: From baseline to after 6 months]
  • Insulin [Time frame: From baseline to after 6 months and after 12 months]
  • Average glucose levels [Time frame: From baseline to after 6 months and after 12 months]
  • Blood cholesterol [Time frame: From baseline to after 6 months and after 12 months]
  • LDL-cholesterol [Time frame: From baseline to after 6 months and after 12 months]
  • HDL-cholesterol [Time frame: From baseline to after 6 months and after 12 months]
  • Triglycerides [Time frame: From baseline to after 6 months and after 12 months]
  • Cardiorespiratory fitness [Time frame: From baseline to after 6 months and after 12 months]
  • Insulin sensitivity [Time frame: From baseline to after 6 months and after 12 months]
  • Body mass [Time frame: From baseline to after 6 months and after 12 months]
  • Fat-free mass [Time frame: From baseline to after 6 months and after 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Norway · 1 center
  • Department of circulation and medical imaging, NTNU — Trondheim

Identifiers

NCT: NCT07036562 · 911308

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗