Time-restricted Eating and High Intensity Interval Training Among Women

Sponsor

Norwegian University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT04019860

Collaborator

Australian Catholic University (Other)

131

Enrollment

Location

Arms

19.1

Actual Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Endocrine	Behavioral: High Intensity Interval Training Behavioral: Time-Restricted Eating	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

131 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Four-armed randomised controlled trialFour-armed randomised controlled trial

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Aug 12, 2019

Actual Primary Completion Date :

Mar 16, 2021

Actual Study Completion Date :

Mar 16, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High Intensity Interval Training High intensity interval training for seven weeks. Three weekly, supervised training sessions.	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.
Experimental: Time-Restricted Eating Time-restricted eating for seven weeks. Maximal daily eating window of 10 hours.	Behavioral: Time-Restricted Eating Restricted daily window of caloric intake to maximum 10 hours. Intervention period will be seven weeks.
Experimental: High Intensity Interval Training & Time-Restricted Eating	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. Behavioral: Time-Restricted Eating 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.

Outcome Measures

Primary Outcome Measures

Glycaemic control [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 Outcome Measures

Insulin sensitivity [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)
Insulin levels after ingestion of glucose [From baseline to after 7 weeks intervention]
Total area under the serum insulin two hours after a 75 g oral glucose tolerance test
Cardiorespiratory fitness [From baseline to after 7 weeks intervention]
Peak oxygen uptake at a maximum effort exercise test, measured in mL/min/kg and L/min
Body mass [From baseline to after 7 weeks intervention]
In kg
Body fat mass [From baseline to after 7 weeks intervention]
In kg
Body fat percentage [From baseline to after 7 weeks intervention]
In percent of total body mass
Fat-free body mass [From baseline to after 7 weeks intervention]
In kg
Fat-free body mass percentage [From baseline to after 7 weeks intervention]
In percent of total body mass
Systolic blood pressure [From baseline to after 7 weeks intervention]
Average of three measurements, in mmHg
Diastolic blood pressure [From baseline to after 7 weeks intervention]
Average of three measurements, in mmHg
Resting heart rate [From baseline to after 7 weeks intervention]
Average of three measurements, in beats/min
Cholesterol in blood [From baseline to after 7 weeks intervention]
Total fasting cholesterol in blood
High density lipoprotein cholesterol in blood [From baseline to after 7 weeks intervention]
Fasting high density lipoprotein cholesterol i blood
Low density lipoprotein cholesterol in blood [From baseline to after 7 weeks intervention]
Fasting low density lipoprotein cholesterol i blood
Triglycerides in blood [From baseline to after 7 weeks intervention]
Fasting low density lipoprotein cholesterol i blood
Average glucose levels [From baseline to after 7 weeks intervention]
Glycated haemoglobin (HbA1c)
Insulinemia [From baseline to after 7 weeks intervention]
Fasting insulin in blood
24 hour glycaemic control [From baseline to the last 14 days of the intervention period]
Average interstitial glucose levels during 24 h, area under the curve
Postprandial glycaemic control [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
Nocturnal glycaemic control [From baseline to the last 14 days of the intervention period]
Average interstitial glucose levels from 23:00 h to 06:00 h
Self-reported physical activity [From baseline to after 7 weeks intervention]
International Physical Activity Questionnaire
Measured physical activity [From baseline to the last 14 days of the intervention period]
Measure by Sensewear activity monitor
Sleep [From baseline to after 7 weeks intervention]
Self-reported: Pittsburgh Sleep Quality Index
Chronotype [From baseline to after 7 weeks intervention]
Self-reported: Hornestberg Morningness Eveningness Questionnaire

Other Outcome Measures

Adherence to high intensity interval training [Seven weeks]
Number of completed exercise sessions out of those prescribed, in percentage
Compliance to high intensity interval training [Seven weeks]
Exercise intensity, heart rate in percentage of individual heart rate maximum
Compliance to time-restricted eating [Seven weeks]
Average daily eating window, in hours
Adherence to time-restricted eating [Seven weeks]
Average number of days where per week that daily eating window is 10 hours or less.
Diet intake at baseline [14 days at baseline (one week of habitual diet and one week after the intervention starts)]
Online food diary
Diet intake [The last 14 days of the intervention]
Online food diary

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of circulation and medical imaging , NTNU	Trondheim		Norway	7491

Sponsors and Collaborators

Norwegian University of Science and Technology
Australian Catholic University

Investigators

Study Director: Øystein T Risa, PhD, Norwegian University of Science and Technology
Principal Investigator: Trine T Moholdt, PhD, Norwegian University of Science and Technology