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Time-restricted Eating and High Intensity Interval Training Among Women

Not Applicable
Completed
Conditions
Obesity; Endocrine
Interventions
Behavioral: High Intensity Interval Training
Behavioral: Time-Restricted Eating
Registration Number
NCT04019860
Lead Sponsor
Norwegian University of Science and Technology
Brief 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. 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
131
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
High Intensity Interval TrainingHigh Intensity Interval TrainingHigh intensity interval training for seven weeks. Three weekly, supervised training sessions.
High Intensity Interval Training & Time-Restricted EatingHigh Intensity Interval Training-
Time-Restricted EatingTime-Restricted EatingTime-restricted eating for seven weeks. Maximal daily eating window of 10 hours.
High Intensity Interval Training & Time-Restricted EatingTime-Restricted Eating-
Primary Outcome Measures
NameTimeMethod
Glycaemic controlFrom baseline to after 7 weeks intervention

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

Secondary Outcome Measures
NameTimeMethod
Body fat massFrom baseline to after 7 weeks intervention

In kg

InsulinemiaFrom baseline to after 7 weeks intervention

Fasting insulin in blood

24 hour glycaemic controlFrom baseline to the last 14 days of the intervention period

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

Nocturnal glycaemic controlFrom baseline to the last 14 days of the intervention period

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

High density lipoprotein cholesterol in bloodFrom baseline to after 7 weeks intervention

Fasting high density lipoprotein cholesterol i blood

Low density lipoprotein cholesterol in bloodFrom baseline to after 7 weeks intervention

Fasting low density lipoprotein cholesterol i blood

Self-reported physical activityFrom baseline to after 7 weeks intervention

International Physical Activity Questionnaire

SleepFrom baseline to after 7 weeks intervention

Self-reported: Pittsburgh Sleep Quality Index

Cardiorespiratory fitnessFrom baseline to after 7 weeks intervention

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

Body massFrom baseline to after 7 weeks intervention

In kg

Fat-free body massFrom baseline to after 7 weeks intervention

In kg

Fat-free body mass percentageFrom baseline to after 7 weeks intervention

In percent of total body mass

Diastolic blood pressureFrom baseline to after 7 weeks intervention

Average of three measurements, in mmHg

Resting heart rateFrom baseline to after 7 weeks intervention

Average of three measurements, in beats/min

Average glucose levelsFrom baseline to after 7 weeks intervention

Glycated haemoglobin (HbA1c)

Insulin sensitivityFrom 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)

Insulin levels after ingestion of glucoseFrom baseline to after 7 weeks intervention

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

Body fat percentageFrom baseline to after 7 weeks intervention

In percent of total body mass

Systolic blood pressureFrom baseline to after 7 weeks intervention

Average of three measurements, in mmHg

Triglycerides in bloodFrom baseline to after 7 weeks intervention

Fasting low density lipoprotein cholesterol i blood

Postprandial glycaemic controlFrom 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

Measured physical activityFrom baseline to the last 14 days of the intervention period

Measure by Sensewear activity monitor

Cholesterol in bloodFrom baseline to after 7 weeks intervention

Total fasting cholesterol in blood

ChronotypeFrom baseline to after 7 weeks intervention

Self-reported: Hornestberg Morningness Eveningness Questionnaire

Trial Locations

Locations (1)

Department of circulation and medical imaging , NTNU

🇳🇴

Trondheim, Norway

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