Time-restricted Eating and High Intensity Interval Training Among Women

August 24, 2026 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
131

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Will be given information about the recommended level of physical activity for health benefits and a healthy diet.
Experimental: High Intensity Interval Training
High intensity interval training for seven weeks. Three weekly, supervised training sessions.
Behavioral: High Intensity Interval Training
Three weekly, supervised exercise sessions with high intensity. Each session will last for 30-45 minutes. Intervention period will be seven weeks.
Experimental: Time-Restricted Eating
Time-restricted eating for seven weeks. Maximal daily eating window of 10 hours.
Behavioral: Time-Restricted Eating
Restricted daily window of caloric intake to maximum 10 hours. Intervention period will be seven weeks.
Experimental: High Intensity Interval Training & Time-Restricted Eating
Behavioral: High Intensity Interval Training
Three weekly, supervised exercise sessions with high intensity. Each session will last for 30-45 minutes. Intervention period will be seven weeks.
Behavioral: Time-Restricted Eating
Restricted daily window of caloric intake to maximum 10 hours. Intervention period will be seven weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycaemic control
Time Frame: From baseline to after 7 weeks intervention
Total area under the plasma glucose curve over two hours after a 75 g oral glucose tolerance test
From baseline to after 7 weeks intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Insulin sensitivity
Time Frame: From baseline to after 7 weeks intervention
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)
From baseline to after 7 weeks intervention
Insulin levels after ingestion of glucose
Time Frame: From baseline to after 7 weeks intervention
Total area under the serum insulin two hours after a 75 g oral glucose tolerance test
From baseline to after 7 weeks intervention
Cardiorespiratory fitness
Time Frame: From baseline to after 7 weeks intervention
Peak oxygen uptake at a maximum effort exercise test, measured in mL/min/kg and L/min
From baseline to after 7 weeks intervention
Body mass
Time Frame: From baseline to after 7 weeks intervention
In kg
From baseline to after 7 weeks intervention
Body fat mass
Time Frame: From baseline to after 7 weeks intervention
In kg
From baseline to after 7 weeks intervention
Body fat percentage
Time Frame: From baseline to after 7 weeks intervention
In percent of total body mass
From baseline to after 7 weeks intervention
Fat-free body mass
Time Frame: From baseline to after 7 weeks intervention
In kg
From baseline to after 7 weeks intervention
Fat-free body mass percentage
Time Frame: From baseline to after 7 weeks intervention
In percent of total body mass
From baseline to after 7 weeks intervention
Systolic blood pressure
Time Frame: From baseline to after 7 weeks intervention
Average of three measurements, in mmHg
From baseline to after 7 weeks intervention
Diastolic blood pressure
Time Frame: From baseline to after 7 weeks intervention
Average of three measurements, in mmHg
From baseline to after 7 weeks intervention
Resting heart rate
Time Frame: From baseline to after 7 weeks intervention
Average of three measurements, in beats/min
From baseline to after 7 weeks intervention
Cholesterol in blood
Time Frame: From baseline to after 7 weeks intervention
Total fasting cholesterol in blood
From baseline to after 7 weeks intervention
High density lipoprotein cholesterol in blood
Time Frame: From baseline to after 7 weeks intervention
Fasting high density lipoprotein cholesterol i blood
From baseline to after 7 weeks intervention
Low density lipoprotein cholesterol in blood
Time Frame: From baseline to after 7 weeks intervention
Fasting low density lipoprotein cholesterol i blood
From baseline to after 7 weeks intervention
Triglycerides in blood
Time Frame: From baseline to after 7 weeks intervention
Fasting low density lipoprotein cholesterol i blood
From baseline to after 7 weeks intervention
Average glucose levels
Time Frame: From baseline to after 7 weeks intervention
Glycated haemoglobin (HbA1c)
From baseline to after 7 weeks intervention
Insulinemia
Time Frame: From baseline to after 7 weeks intervention
Fasting insulin in blood
From baseline to after 7 weeks intervention
24 hour glycaemic control
Time Frame: From baseline to the last 14 days of the intervention period
Average interstitial glucose levels during 24 h, area under the curve
From baseline to the last 14 days of the intervention period
Postprandial glycaemic control
Time Frame: From baseline to the last 14 days of the intervention period
Average interstitial glucose levels 3 hours after the first meal of the day, area under the curve
From baseline to the last 14 days of the intervention period
Nocturnal glycaemic control
Time Frame: From baseline to the last 14 days of the intervention period
Average interstitial glucose levels from 23:00 h to 06:00 h
From baseline to the last 14 days of the intervention period
Self-reported physical activity
Time Frame: From baseline to after 7 weeks intervention
International Physical Activity Questionnaire
From baseline to after 7 weeks intervention
Measured physical activity
Time Frame: From baseline to the last 14 days of the intervention period
Measure by Sensewear activity monitor
From baseline to the last 14 days of the intervention period
Sleep
Time Frame: From baseline to after 7 weeks intervention
Self-reported: Pittsburgh Sleep Quality Index
From baseline to after 7 weeks intervention
Chronotype
Time Frame: From baseline to after 7 weeks intervention
Self-reported: Hornestberg Morningness Eveningness Questionnaire
From baseline to after 7 weeks intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence to high intensity interval training
Time Frame: Seven weeks
Number of completed exercise sessions out of those prescribed, in percentage
Seven weeks
Compliance to high intensity interval training
Time Frame: Seven weeks
Exercise intensity, heart rate in percentage of individual heart rate maximum
Seven weeks
Compliance to time-restricted eating
Time Frame: Seven weeks
Average daily eating window, in hours
Seven weeks
Adherence to time-restricted eating
Time Frame: Seven weeks
Average number of days where per week that daily eating window is 10 hours or less.
Seven weeks
Diet intake at baseline
Time Frame: 14 days at baseline (one week of habitual diet and one week after the intervention starts)
Online food diary
14 days at baseline (one week of habitual diet and one week after the intervention starts)
Diet intake
Time Frame: The last 14 days of the intervention
Online food diary
The last 14 days of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Norwegian University of Science and Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Australian Catholic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Øystein T Risa, PhD, Norwegian University of Science and Technology
  • Principal Investigator: Trine T Moholdt, PhD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 16, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019/851
  • 285171 (Other Identifier: Comittee for Medical and Health Research Ethics Mid Norway)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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