Clinical trial NCT04019860: Time-restricted Eating and High Intensity Interval Training Among Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity; Endocrine
Keywords: Exercise
Diet
Overweight
Glycaemic control
Fitness
Body composition
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Australian Catholic University
First posted: 2019-07-15
Enrollment: 131
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four-armed randomised controlled trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glycaemic control
timeFrame: From baseline to after 7 weeks intervention
Secondary outcomes:
measure: Insulin sensitivity
timeFrame: From baseline to after 7 weeks intervention
measure: Insulin levels after ingestion of glucose
timeFrame: From baseline to after 7 weeks intervention
measure: Cardiorespiratory fitness
timeFrame: From baseline to after 7 weeks intervention
measure: Body mass
timeFrame: From baseline to after 7 weeks intervention
measure: Body fat mass
timeFrame: From baseline to after 7 weeks intervention
measure: Body fat percentage
timeFrame: From baseline to after 7 weeks intervention
measure: Fat-free body mass
timeFrame: From baseline to after 7 weeks intervention
measure: Fat-free body mass percentage
timeFrame: From baseline to after 7 weeks intervention
measure: Systolic blood pressure
timeFrame: From baseline to after 7 weeks intervention
measure: Diastolic blood pressure
timeFrame: From baseline to after 7 weeks intervention
measure: Resting heart rate
timeFrame: From baseline to after 7 weeks intervention
measure: Cholesterol in blood
timeFrame: From baseline to after 7 weeks intervention
measure: High density lipoprotein cholesterol in blood
timeFrame: From baseline to after 7 weeks intervention
measure: Low density lipoprotein cholesterol in blood
timeFrame: From baseline to after 7 weeks intervention
measure: Triglycerides in blood
timeFrame: From baseline to after 7 weeks intervention
measure: Average glucose levels
timeFrame: From baseline to after 7 weeks intervention
measure: Insulinemia
timeFrame: From baseline to after 7 weeks intervention
measure: 24 hour glycaemic control
timeFrame: From baseline to the last 14 days of the intervention period
measure: Postprandial glycaemic control
timeFrame: From baseline to the last 14 days of the intervention period
measure: Nocturnal glycaemic control
timeFrame: From baseline to the last 14 days of the intervention period
measure: Self-reported physical activity
timeFrame: From baseline to after 7 weeks intervention
measure: Measured physical activity
timeFrame: From baseline to the last 14 days of the intervention period
measure: Sleep
timeFrame: From baseline to after 7 weeks intervention
measure: Chronotype
timeFrame: From baseline to after 7 weeks intervention
Other outcomes:
measure: Adherence to high intensity interval training
timeFrame: Seven weeks
measure: Compliance to high intensity interval training
timeFrame: Seven weeks
measure: Compliance to time-restricted eating
timeFrame: Seven weeks
measure: Adherence to time-restricted eating
timeFrame: Seven weeks
measure: Diet intake at baseline
timeFrame: 14 days at baseline (one week of habitual diet and one week after the intervention starts)
measure: Diet intake
timeFrame: The last 14 days of the intervention
Locations:
city: Trondheim
country: Norway
facility: Department of circulation and medical imaging , NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Øystein T Risa, PhD
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology
name: Trine T Moholdt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.