Overweight and ObesityTREHIIT-3NCT07036562
Time-restricted Eating and High-intensity Interval Training for Metabolic Health in Adults With Overweight/Obesity
A study testing Time-restricted eating and high-intensity interval training in people with Overweight and Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Time-restricted eating and high-intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 11 Sep 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index ≥ 27 kg/m²
- Able to walk or ride a bike > 60 min
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of circulation and medical imaging, NTNU
Trondheim, 7491
About this study
Official title: Time-restricted Eating and High-intensity Interval Training for Long-term Improvement in Metabolic Health
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.
- Conditions
- Overweight and Obesity
- Being tested
- Time-restricted eating and high-intensity interval training
- Keywords
- time-restricted eating, high-intensity interval training, exercise, diet, metabolic health, lifestyle intervention
- Medical subject headings
- Overweight, Obesity, Intermittent Fasting, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted eating and high-intensity interval trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Time-restricted eating and high-intensity interval training | Experimental | 12 months of periodised time-restricted eating and high-intensity interval training with digital follow-up Receives: Behavioral: Time-restricted eating and high-intensity interval training |
| Control | No intervention | No intervention or follow-up. Habitual lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fat mass
Change in total fat mass measured with bioelectrical impedance analysis
Measured: From baseline to after 12 months
Secondary outcomes (19)
Blood glucose
Fasting concentration of plasma glucose
Measured: From baseline to after 6 months and after 12 months
Total fat mass
Change in total fat mass measured with bioelectrical impedance analysis
Measured: From baseline to after 6 months
Insulin
Fasting concentration of plasma insulin C-peptide
Measured: From baseline to after 6 months and after 12 months
Average glucose levels
Glycated haemoglobin (HbA1c)
Measured: From baseline to after 6 months and after 12 months
Blood cholesterol
Total fasting cholesterol in blood
Measured: From baseline to after 6 months and after 12 months
LDL-cholesterol
Fasting low-density lipoprotein-cholesterol in blood
Measured: From baseline to after 6 months and after 12 months
HDL-cholesterol
Fasting high-density lipoprotein-cholesterol in blood
Measured: From baseline to after 6 months and after 12 months
Triglycerides
Fasting triglycerides in blood
Measured: From baseline to after 6 months and after 12 months
Cardiorespiratory fitness
Peak oxygen uptake at a maximum effort test, measured in mL/min/kg and L/min
Measured: From baseline to after 6 months and after 12 months
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
Measured: From baseline to after 6 months and after 12 months
Body mass
In kg, estimated with bioelectrical impedance analysis
Measured: From baseline to after 6 months and after 12 months
Fat-free mass
In kg, estimated with bioelectrical impedance analysis
Measured: From baseline to after 6 months and after 12 months
Visceral fat area
In cm2, estimated with bioelectrical impedance analysis
Measured: From baseline to after 6 months and after 12 months
Systolic blood pressure
Average of three measurements during rest in seated position, in mmHg
Measured: From baseline to after 6 months and after 12 months
Diastolic blood pressure
Average of three measurements during rest in seated position, in mmHg
Measured: From baseline to after 6 months and after 12 months
Resting heart rate
Average of three measurements during rest in sitting position, in beats/min
Measured: From baseline to after 6 months and after 12 months
Physical activity levels
International Physical Activity Questionnaire
Measured: From baseline to after 6 months and after 12 months
Diet intake
3-day diet diaries (two weekdays and one weekend day) with online diet diary.
Measured: During baseline week, after 4, 13, 30, and 50 weeks.
Sleep quality
The Pittsburgh Sleep Quality Index questionnaire
Measured: From baseline to after 6 months and after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start11 Sep 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036562
- Sponsor's protocol ID
- 911308
- Acronym
- TREHIIT-3
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-restricted Eating and High-intensity Interval Training for Long-term Improvement in Metabolic Health
- ClinicalTrials.gov ID
- NCT07036562
- Acronym / sponsor ID
- TREHIIT-3 / 911308
- Conditions
- Overweight and Obesity
- Keywords
- time-restricted eating, high-intensity interval training, exercise, diet, metabolic health, lifestyle intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time-restricted eating and high-intensity interval training | Experimental | Behavioral: Time-restricted eating and high-intensity interval training12 months of periodised time-restricted eating and high-intensity interval training with digital follow-up |
| Control | No intervention | –No intervention or follow-up. Habitual lifestyle |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index ≥ 27 kg/m²
- Able to walk or ride a bike > 60 min
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-restricted eating and high-intensity interval training1-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. | Behavioural | Time-restricted eating and high-intensity interval training |
Primary outcome
Total fat mass
Time frame: From baseline to after 12 months
Change in total fat mass measured with bioelectrical impedance analysis
19 secondary outcomes
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
Visceral fat area
Time frame: From baseline to after 6 months and after 12 months
Systolic blood pressure
Time frame: From baseline to after 6 months and after 12 months
Diastolic blood pressure
Time frame: From baseline to after 6 months and after 12 months
Resting heart rate
Time frame: From baseline to after 6 months and after 12 months
Physical activity levels
Time frame: From baseline to after 6 months and after 12 months
Diet intake
Time frame: During baseline week, after 4, 13, 30, and 50 weeks.
Sleep quality
Time frame: From baseline to after 6 months and after 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: 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.
Related trials for Overweight and Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted eating and high-intensity interval training in people with Overweight and Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total fat mass (time frame: From baseline to after 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.