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Obesity; EndocrineNCT04019860

Time-restricted Eating and High Intensity Interval Training Among Women

A study testing High Intensity Interval Training and Time-Restricted Eating in people with Obesity; Endocrine, run by Norwegian University of Science and Technology at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project will determine the independent and combined effects of high intensity interval training and time-restricted eating on blood sugar regulation among women in reproductive-age who have overweight or obesity. The intervention period will be seven weeks. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Obesity; Endocrine
What is being tested?
High Intensity Interval Training and Time-Restricted Eating
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
1 siteNorway
Study dates
12 Aug 2019to 16 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

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 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • body mass index ≥ 27 kg/cm2,
  • able to walk on a treadmill or ride a bike for at least 60 min.

Who cannot join

  • Pregnancy, lactation within 24 weeks of study commencement
  • known cardiovascular disease
  • type 1 or 2 diabetes
  • currently taking hypertension or glucose- or lipid-lowering medication
  • habitual eating window < 12 hours
  • performing high intensity training more than once a week
  • body mass variations > 4 kg three months prior to study commencement
  • shift work that includes night shifts.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Department of circulation and medical imaging , NTNU

    Trondheim, 7491

Other trials in Norway

About this study

Official title: Isolated and Combined Effects of High Intensity Interval Training and Time Restricted Eating on Glycaemic Control in Reproductive-aged Women With Overweight or Obesity

This project will determine the independent and combined effects of high intensity interval training and time-restricted eating on blood sugar regulation among women in reproductive-age who have overweight or obesity. The intervention period will be seven weeks. Before and after the intervention, blood sugar regulation, body composition and physical fitness will be measured and compared between groups who are doing either high intensity interval training, time-restricted eating, both high intensity interval training and time-restricted eating, or who are in a control group. Physical activity, sleep quality, continuous glucose monitoring, adherence to the interventions and hunger/satiety will also be measured.

Read the detailed description

In a follow-up study, we will invite randomized participants to come in for new assessments of physical fitness, body composition and fasting blood samples, and they will be asked to complete questionnaires about adherence to the interventions two years after intervention-end. The first participants will come in to the laboratory for the two-year follow up in November 2021.

Being tested
High Intensity Interval Training, Time-Restricted Eating
Keywords
Exercise, Diet, Overweight, Glycaemic control, Fitness, Body composition
Medical subject headings
Obesity, Motor Activity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Intensity Interval TrainingBehavioural

    Three weekly, supervised exercise sessions with high intensity. Each session will last for 30-45 minutes. Intervention period will be seven weeks.

  • Time-Restricted EatingBehavioural

    Restricted daily window of caloric intake to maximum 10 hours. Intervention period will be seven weeks.

Study groups in NCT04019860
Study groupRoleWhat they receive
High Intensity Interval TrainingExperimentalHigh intensity interval training for seven weeks. Three weekly, supervised training sessions.
Receives: Behavioral: High Intensity Interval Training
Time-Restricted EatingExperimentalTime-restricted eating for seven weeks. Maximal daily eating window of 10 hours.
Receives: Behavioral: Time-Restricted Eating
High Intensity Interval Training & Time-Restricted EatingExperimentalNot described
Receives: Behavioral: High Intensity Interval Training; Behavioral: Time-Restricted Eating
ControlNo interventionWill be given information about the recommended level of physical activity for health benefits and a healthy diet.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycaemic control

    Total area under the plasma glucose curve over two hours after a 75 g oral glucose tolerance test

    Measured: From baseline to after 7 weeks intervention

Secondary outcomes (24)

  1. Insulin sensitivity

    Insulin sensitivity estimated by homeostatic model assessment for insulin resistance (fasting serum insulin concentration (μU/mL) x fasting plasma glucose levels (mmol/L)/22.5)

    Measured: From baseline to after 7 weeks intervention

  2. Insulin levels after ingestion of glucose

    Total area under the serum insulin two hours after a 75 g oral glucose tolerance test

    Measured: From baseline to after 7 weeks intervention

  3. Cardiorespiratory fitness

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

    Measured: From baseline to after 7 weeks intervention

  4. Body mass

    In kg

    Measured: From baseline to after 7 weeks intervention

  5. Body fat mass

    In kg

    Measured: From baseline to after 7 weeks intervention

  6. Body fat percentage

    In percent of total body mass

    Measured: From baseline to after 7 weeks intervention

  7. Fat-free body mass

    In kg

    Measured: From baseline to after 7 weeks intervention

  8. Fat-free body mass percentage

    In percent of total body mass

    Measured: From baseline to after 7 weeks intervention

  9. Systolic blood pressure

    Average of three measurements, in mmHg

    Measured: From baseline to after 7 weeks intervention

  10. Diastolic blood pressure

    Average of three measurements, in mmHg

    Measured: From baseline to after 7 weeks intervention

  11. Resting heart rate

    Average of three measurements, in beats/min

    Measured: From baseline to after 7 weeks intervention

  12. Cholesterol in blood

    Total fasting cholesterol in blood

    Measured: From baseline to after 7 weeks intervention

  13. High density lipoprotein cholesterol in blood

    Fasting high density lipoprotein cholesterol i blood

    Measured: From baseline to after 7 weeks intervention

  14. Low density lipoprotein cholesterol in blood

    Fasting low density lipoprotein cholesterol i blood

    Measured: From baseline to after 7 weeks intervention

  15. Triglycerides in blood

    Fasting low density lipoprotein cholesterol i blood

    Measured: From baseline to after 7 weeks intervention

  16. Average glucose levels

    Glycated haemoglobin (HbA1c)

    Measured: From baseline to after 7 weeks intervention

  17. Insulinemia

    Fasting insulin in blood

    Measured: From baseline to after 7 weeks intervention

  18. 24 hour glycaemic control

    Average interstitial glucose levels during 24 h, area under the curve

    Measured: From baseline to the last 14 days of the intervention period

  19. Postprandial glycaemic control

    Average interstitial glucose levels 3 hours after the first meal of the day, area under the curve

    Measured: From baseline to the last 14 days of the intervention period

  20. Nocturnal glycaemic control

    Average interstitial glucose levels from 23:00 h to 06:00 h

    Measured: From baseline to the last 14 days of the intervention period

  21. Self-reported physical activity

    International Physical Activity Questionnaire

    Measured: From baseline to after 7 weeks intervention

  22. Measured physical activity

    Measure by Sensewear activity monitor

    Measured: From baseline to the last 14 days of the intervention period

  23. Sleep

    Self-reported: Pittsburgh Sleep Quality Index

    Measured: From baseline to after 7 weeks intervention

  24. Chronotype

    Self-reported: Hornestberg Morningness Eveningness Questionnaire

    Measured: From baseline to after 7 weeks intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2019
  2. Study start12 Aug 2019
  3. Primary completion16 Mar 2021
  4. Study completion16 Mar 2021

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Four-armed randomised controlled trial
Masking
None (open label)
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04019860
Sponsor's protocol ID
2019/851
Other IDs
285171
Status last verified
Aug 2026
First submitted
9 Jul 2019
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Haganes KL, Hawley JA, Lydersen S, Moholdt T. Maintenance of time-restricted eating and high-intensity interval training in women with overweight/obesity 2 years after a randomized controlled trial. Sci Rep. 2025 Apr 25;15(1):14520. doi: 10.1038/s41598-025-95743-y.

    PubMed 40280987

  • Haganes KL, Devlin BL, Orr RK, Moholdt T. Impact of Time-Restricted Eating and High-Intensity Exercise on Nutrient Intake in Women with Overweight/Obesity: Secondary Analysis of a Randomized Controlled Trial. Nutrients. 2025 Jan 8;17(2):218. doi: 10.3390/nu17020218.

    PubMed 39861348

  • Haganes KL, Silva CP, Eyjolfsdottir SK, Steen S, Grindberg M, Lydersen S, Hawley JA, Moholdt T. Time-restricted eating and exercise training improve HbA1c and body composition in women with overweight/obesity: A randomized controlled trial. Cell Metab. 2022 Oct 4;34(10):1457-1471.e4. doi: 10.1016/j.cmet.2022.09.003.

    PubMed 36198292

  • Duc TQ, Nguyen Di K, Quy PN. Interaction between time-restricted eating and high-intensity interval training on cardiometabolic outcomes in women with overweight or obesity: a 2 x 2 factorial randomised controlled trial. Br J Nutr. 2026 Sep 25:1-10. doi: 10.1017/S0007114526108484. Online ahead of print.

    PubMed 42788200

  • Moholdt T, Silva CP, Lydersen S, Hawley JA. Isolated and combined effects of high-intensity interval training and time-restricted eating on glycaemic control in reproductive-aged women with overweight or obesity: study protocol for a four-armed randomised controlled trial. BMJ Open. 2021 Feb 5;11(2):e040020. doi: 10.1136/bmjopen-2020-040020.

    PubMed 33550228

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Interval Training and Time-Restricted Eating in people with Obesity; Endocrine, 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: finished, as of the sponsor's last update on 26 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Glycaemic control (time frame: From baseline to after 7 weeks intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04019860, which also lists 5 linked publications.

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 26 Aug 2026.

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