Time-restricted Eating and High Intensity Interval Training Among Women

Obesity; Endocrine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04019860
• Other study ID #: 2019/851
• Secondary ID: 285171
• Status: Completed
• Phase: N/A
• Start date: August 12, 2019
• Est. completion date: March 16, 2021

Study information

• Verified date: September 2021
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: March 16, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Obesity; Endocrine

Intervention

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

Locations

Country	Name	City	State
Norway	Department of circulation and medical imaging , NTNU	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Australian Catholic University

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to high intensity interval training	Number of completed exercise sessions out of those prescribed, in percentage	Seven weeks
Other	Compliance to high intensity interval training	Exercise intensity, heart rate in percentage of individual heart rate maximum	Seven weeks
Other	Compliance to time-restricted eating	Average daily eating window, in hours	Seven weeks
Other	Adherence to time-restricted eating	Average number of days where per week that daily eating window is 10 hours or less.	Seven weeks
Other	Diet intake at baseline	Online food diary	14 days at baseline (one week of habitual diet and one week after the intervention starts)
Other	Diet intake	Online food diary	The last 14 days of the intervention
Primary	Glycaemic control	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	Insulin sensitivity	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
Secondary	Insulin levels after ingestion of glucose	Total area under the serum insulin two hours after a 75 g oral glucose tolerance test	From baseline to after 7 weeks intervention
Secondary	Cardiorespiratory fitness	Peak oxygen uptake at a maximum effort exercise test, measured in mL/min/kg and L/min	From baseline to after 7 weeks intervention
Secondary	Body mass	In kg	From baseline to after 7 weeks intervention
Secondary	Body fat mass	In kg	From baseline to after 7 weeks intervention
Secondary	Body fat percentage	In percent of total body mass	From baseline to after 7 weeks intervention
Secondary	Fat-free body mass	In kg	From baseline to after 7 weeks intervention
Secondary	Fat-free body mass percentage	In percent of total body mass	From baseline to after 7 weeks intervention
Secondary	Systolic blood pressure	Average of three measurements, in mmHg	From baseline to after 7 weeks intervention
Secondary	Diastolic blood pressure	Average of three measurements, in mmHg	From baseline to after 7 weeks intervention
Secondary	Resting heart rate	Average of three measurements, in beats/min	From baseline to after 7 weeks intervention
Secondary	Cholesterol in blood	Total fasting cholesterol in blood	From baseline to after 7 weeks intervention
Secondary	High density lipoprotein cholesterol in blood	Fasting high density lipoprotein cholesterol i blood	From baseline to after 7 weeks intervention
Secondary	Low density lipoprotein cholesterol in blood	Fasting low density lipoprotein cholesterol i blood	From baseline to after 7 weeks intervention
Secondary	Triglycerides in blood	Fasting low density lipoprotein cholesterol i blood	From baseline to after 7 weeks intervention
Secondary	Average glucose levels	Glycated haemoglobin (HbA1c)	From baseline to after 7 weeks intervention
Secondary	Insulinemia	Fasting insulin in blood	From baseline to after 7 weeks intervention
Secondary	24 hour glycaemic control	Average interstitial glucose levels during 24 h, area under the curve	From baseline to the last 14 days of the intervention period
Secondary	Postprandial glycaemic control	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
Secondary	Nocturnal glycaemic control	Average interstitial glucose levels from 23:00 h to 06:00 h	From baseline to the last 14 days of the intervention period
Secondary	Self-reported physical activity	International Physical Activity Questionnaire	From baseline to after 7 weeks intervention
Secondary	Measured physical activity	Measure by Sensewear activity monitor	From baseline to the last 14 days of the intervention period
Secondary	Sleep	Self-reported: Pittsburgh Sleep Quality Index	From baseline to after 7 weeks intervention
Secondary	Chronotype	Self-reported: Hornestberg Morningness Eveningness Questionnaire	From baseline to after 7 weeks intervention