Time-restricted Eating and High Intensity Interval Training Among Women

Isolated and Combined Effects of High Intensity Interval Training and Time Restricted Eating on Glycaemic Control in Reproductive-aged Women With Overweight or Obesity

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Endocrine
• Intervention / Treatment: Behavioral: High Intensity Interval Training; Behavioral: Time-Restricted Eating

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 Type: Interventional
• Enrollment (Actual): 131
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway, 7491
    • Department of circulation and medical imaging , NTNU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Body mass	In kg	From baseline to after 7 weeks intervention
Body fat mass	In kg	From baseline to after 7 weeks intervention
Body fat percentage	In percent of total body mass	From baseline to after 7 weeks intervention
Fat-free body mass	In kg	From baseline to after 7 weeks intervention
Fat-free body mass percentage	In percent of total body mass	From baseline to after 7 weeks intervention
Systolic blood pressure	Average of three measurements, in mmHg	From baseline to after 7 weeks intervention
Diastolic blood pressure	Average of three measurements, in mmHg	From baseline to after 7 weeks intervention
Resting heart rate	Average of three measurements, in beats/min	From baseline to after 7 weeks intervention
Cholesterol in blood	Total fasting cholesterol in blood	From baseline to after 7 weeks intervention
High density lipoprotein cholesterol in blood	Fasting high density lipoprotein cholesterol i blood	From baseline to after 7 weeks intervention
Low density lipoprotein cholesterol in blood	Fasting low density lipoprotein cholesterol i blood	From baseline to after 7 weeks intervention
Triglycerides in blood	Fasting low density lipoprotein cholesterol i blood	From baseline to after 7 weeks intervention
Average glucose levels	Glycated haemoglobin (HbA1c)	From baseline to after 7 weeks intervention
Insulinemia	Fasting insulin in blood	From baseline to after 7 weeks intervention
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
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
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
Self-reported physical activity	International Physical Activity Questionnaire	From baseline to after 7 weeks intervention
Measured physical activity	Measure by Sensewear activity monitor	From baseline to the last 14 days of the intervention period
Sleep	Self-reported: Pittsburgh Sleep Quality Index	From baseline to after 7 weeks intervention
Chronotype	Self-reported: Hornestberg Morningness Eveningness Questionnaire	From baseline to after 7 weeks intervention

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Australian Catholic University
• Investigators: Study Director: Øystein T Risa, PhD, Norwegian University of Science and Technology

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 12, 2019
• Primary Completion (ACTUAL): March 16, 2021
• Study Completion (ACTUAL): March 16, 2021

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (ACTUAL): July 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Exercise; Overweight; Body composition; Diet; Fitness; Glycaemic control
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 2019/851; 285171 (OTHER: Comittee for Medical and Health Research Ethics Mid Norway)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No