- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04019860
Time-restricted Eating and High Intensity Interval Training Among Women
September 13, 2021 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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
131
Phase
- 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
-
-
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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
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: High Intensity Interval Training
High intensity interval training for seven weeks.
Three weekly, supervised training sessions.
|
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.
|
Restricted daily window of caloric intake to maximum 10 hours.
Intervention period will be seven weeks.
|
EXPERIMENTAL: High Intensity Interval Training & Time-Restricted Eating
|
Three weekly, supervised exercise sessions with high intensity.
Each session will last for 30-45 minutes.
Intervention period will be seven weeks.
Restricted daily window of caloric intake to maximum 10 hours.
Intervention period will be seven weeks.
|
NO_INTERVENTION: Control
Will be given information about the recommended level of physical activity for health benefits and a healthy diet.
|
What is the study measuring?
Primary Outcome Measures
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
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
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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
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From baseline to the last 14 days of the intervention period
|
Self-reported physical activity
Time Frame: From baseline to after 7 weeks intervention
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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
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Measure by Sensewear activity monitor
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From baseline to the last 14 days of the intervention period
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Sleep
Time Frame: From baseline to after 7 weeks intervention
|
Self-reported: Pittsburgh Sleep Quality Index
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From baseline to after 7 weeks intervention
|
Chronotype
Time Frame: From baseline to after 7 weeks intervention
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Self-reported: Hornestberg Morningness Eveningness Questionnaire
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From baseline to after 7 weeks intervention
|
Other Outcome Measures
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.
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Seven weeks
|
Diet intake at baseline
Time Frame: 14 days at baseline (one week of habitual diet and one week after the intervention starts)
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Online food diary
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14 days at baseline (one week of habitual diet and one week after the intervention starts)
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Diet intake
Time Frame: The last 14 days of the intervention
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Online food diary
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The last 14 days of the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Øystein T Risa, 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
- 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.
- 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.
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)
August 12, 2019
Primary Completion (ACTUAL)
March 16, 2021
Study Completion (ACTUAL)
March 16, 2021
Study Registration Dates
First Submitted
July 9, 2019
First Submitted That Met QC Criteria
July 12, 2019
First Posted (ACTUAL)
July 15, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 20, 2021
Last Update Submitted That Met QC Criteria
September 13, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/851
- 285171 (OTHER: 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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