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Active, not recruitingNCT07036562TREHIIT-3Updated Aug 13, 2026

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

An interventional study of Time-restricted eating and high-intensity interval training in Overweight and Obesity, sponsored by Norwegian University of Science and Technology. Active, not recruiting at 1 site in Norway. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Overweight and Obesity

Keywords

  • time-restricted eating
  • high-intensity interval training
  • exercise
  • diet
  • metabolic health
  • lifestyle intervention
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's planned enrollment of 100 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Time-restricted eating and high-intensity interval training

    12 months of periodised time-restricted eating and high-intensity interval training with digital follow-up

    Behavioral: Time-restricted eating and high-intensity interval training

  • No intervention
    Control

    No intervention or follow-up. Habitual lifestyle

Interventions

  • BehavioralTime-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. The intervention period will be 12 months in total.

06

What researchers measure

Primary outcomes

  1. Total fat mass

    Change in total fat mass measured with bioelectrical impedance analysis

    Time frame: From baseline to after 12 months

Secondary outcomes

  1. Blood glucose

    Fasting concentration of plasma glucose

    Time frame: From baseline to after 6 months and after 12 months

  2. Total fat mass

    Change in total fat mass measured with bioelectrical impedance analysis

    Time frame: From baseline to after 6 months

  3. Insulin

    Fasting concentration of plasma insulin C-peptide

    Time frame: From baseline to after 6 months and after 12 months

  4. Average glucose levels

    Glycated haemoglobin (HbA1c)

    Time frame: From baseline to after 6 months and after 12 months

  5. Blood cholesterol

    Total fasting cholesterol in blood

    Time frame: From baseline to after 6 months and after 12 months

  6. LDL-cholesterol

    Fasting low-density lipoprotein-cholesterol in blood

    Time frame: From baseline to after 6 months and after 12 months

  7. HDL-cholesterol

    Fasting high-density lipoprotein-cholesterol in blood

    Time frame: From baseline to after 6 months and after 12 months

  8. Triglycerides

    Fasting triglycerides in blood

    Time frame: From baseline to after 6 months and after 12 months

  9. Cardiorespiratory fitness

    Peak oxygen uptake at a maximum effort test, measured in mL/min/kg and L/min

    Time frame: From baseline to after 6 months and after 12 months

  10. Insulin sensitivity

    Homeostatic model assessment for insulin resistance (HOMA-IR): 1.5 + fasting plasma glucose (mmol/L) x fasting plasma insulin C-peptide (pmol/L)/2800

    Time frame: From baseline to after 6 months and after 12 months

  11. Body mass

    In kg, estimated with bioelectrical impedance analysis

    Time frame: From baseline to after 6 months and after 12 months

  12. Fat-free mass

    In kg, estimated with bioelectrical impedance analysis

    Time frame: From baseline to after 6 months and after 12 months

  13. Visceral fat area

    In cm2, estimated with bioelectrical impedance analysis

    Time frame: From baseline to after 6 months and after 12 months

  14. Systolic blood pressure

    Average of three measurements during rest in seated position, in mmHg

    Time frame: From baseline to after 6 months and after 12 months

  15. Diastolic blood pressure

    Average of three measurements during rest in seated position, in mmHg

    Time frame: From baseline to after 6 months and after 12 months

  16. Resting heart rate

    Average of three measurements during rest in sitting position, in beats/min

    Time frame: From baseline to after 6 months and after 12 months

  17. Physical activity levels

    International Physical Activity Questionnaire

    Time frame: From baseline to after 6 months and after 12 months

  18. Diet intake

    3-day diet diaries (two weekdays and one weekend day) with online diet diary.

    Time frame: During baseline week, after 4, 13, 30, and 50 weeks.

  19. Sleep quality

    The Pittsburgh Sleep Quality Index questionnaire

    Time frame: From baseline to after 6 months and after 12 months

Other outcomes

  1. Adherence to high-intensity interval training

    Number of completed exercise sessions out of those prescribed, in percentage

    Time frame: 12 months

  2. Compliance to high-intensity interval training

    Exercise intensity measured with pulse sensor. Heart rate percentage of individual heart rate maximum.

    Time frame: 12 months

  3. Adherence to time-restricted eating

    Average number of days per week a daily eating window of 10 hours or less was achieved

    Time frame: During baseline week, after 4, 13, 30, and 50 weeks.

  4. Compliance to time-restricted eating

    Average daily eating window, self-reported in hours/day

    Time frame: During baseline week, after 4, 13, 30, and 50 weeks.

  5. Perception of intervention and digital follow-up

    Qualitative interviews with selected participants to explore barriers and motivators

    Time frame: After 12 months

  6. Sex differences

    Sub-analyses of sex differences in the effectiveness of the intervention

    Time frame: From baseline to after 6 months and after 12 months

07

Study locations

1 site
  • Department of circulation and medical imaging, NTNU
    Trondheim, 7491, Norway
08

References and documents

Individual participant data

Plan to share: Yes — We will make de-identified individual participant data (IPD) collected in the study available to other researchers. We will upload a data set in an open access repository. We will only share IPD that cannot be used to identify individuals.

Supporting information: Study protocol, Sap, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07036562
Lead sponsor
Norwegian University of Science and Technology
Responsible party
Sponsor
First posted
Jun 25, 2025
Start date
Sep 11, 2025
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Aug 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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