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Completed

NCT Number: NCT04019860

Time-restricted Eating and High Intensity Interval Training Among Women

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.

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Key information

Conditions

Obesity; Endocrine Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of circulation and medical imaging , NTNU

Trondheim, 7491, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Intensity Interval Training

Behavioral

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

Time-restricted eating

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. Body mass

    Time frame: From baseline to after 7 weeks intervention

    In kg

  5. Body fat mass

    Time frame: From baseline to after 7 weeks intervention

    In kg

  6. Body fat percentage

    Time frame: From baseline to after 7 weeks intervention

    In percent of total body mass

  7. Fat-free body mass

    Time frame: From baseline to after 7 weeks intervention

    In kg

  8. Fat-free body mass percentage

    Time frame: From baseline to after 7 weeks intervention

    In percent of total body mass

  9. Systolic blood pressure

    Time frame: From baseline to after 7 weeks intervention

    Average of three measurements, in mmHg

  10. Diastolic blood pressure

    Time frame: From baseline to after 7 weeks intervention

    Average of three measurements, in mmHg

  11. Resting heart rate

    Time frame: From baseline to after 7 weeks intervention

    Average of three measurements, in beats/min

  12. Cholesterol in blood

    Time frame: From baseline to after 7 weeks intervention

    Total fasting cholesterol in blood

  13. High density lipoprotein cholesterol in blood

    Time frame: From baseline to after 7 weeks intervention

    Fasting high density lipoprotein cholesterol i blood

  14. Low density lipoprotein cholesterol in blood

    Time frame: From baseline to after 7 weeks intervention

    Fasting low density lipoprotein cholesterol i blood

  15. Triglycerides in blood

    Time frame: From baseline to after 7 weeks intervention

    Fasting low density lipoprotein cholesterol i blood

  16. Average glucose levels

    Time frame: From baseline to after 7 weeks intervention

    Glycated haemoglobin (HbA1c)

  17. Insulinemia

    Time frame: From baseline to after 7 weeks intervention

    Fasting insulin in blood

  18. 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

  19. 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

  20. 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

  21. Self-reported physical activity

    Time frame: From baseline to after 7 weeks intervention

    International Physical Activity Questionnaire

  22. Measured physical activity

    Time frame: From baseline to the last 14 days of the intervention period

    Measure by Sensewear activity monitor

  23. Sleep

    Time frame: From baseline to after 7 weeks intervention

    Self-reported: Pittsburgh Sleep Quality Index

  24. Chronotype

    Time frame: From baseline to after 7 weeks intervention

    Self-reported: Hornestberg Morningness Eveningness Questionnaire

Other outcomes

  1. Adherence to high intensity interval training

    Time frame: Seven weeks

    Number of completed exercise sessions out of those prescribed, in percentage

  2. Compliance to high intensity interval training

    Time frame: Seven weeks

    Exercise intensity, heart rate in percentage of individual heart rate maximum

  3. Compliance to time-restricted eating

    Time frame: Seven weeks

    Average daily eating window, in hours

  4. 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.

  5. 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

  6. Diet intake

    Time frame: The last 14 days of the intervention

    Online food diary

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Australian Catholic University

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 15, 2019
Registry last updated
Sep 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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