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

Sponsors

Lead Sponsor: Norwegian University of Science and Technology

Collaborator: Australian Catholic University

Source Norwegian University of Science and Technology
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.

Overall Status Recruiting
Start Date August 12, 2019
Completion Date March 31, 2021
Primary Completion Date March 31, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Glycaemic control From baseline to after 7 weeks intervention
Secondary Outcome
Measure Time Frame
Insulin sensitivity From baseline to after 7 weeks intervention
Insulin levels after ingestion of glucose From baseline to after 7 weeks intervention
Cardiorespiratory fitness From baseline to after 7 weeks intervention
Body mass From baseline to after 7 weeks intervention
Body fat mass From baseline to after 7 weeks intervention
Body fat percentage From baseline to after 7 weeks intervention
Fat-free body mass From baseline to after 7 weeks intervention
Fat-free body mass percentage From baseline to after 7 weeks intervention
Systolic blood pressure From baseline to after 7 weeks intervention
Diastolic blood pressure From baseline to after 7 weeks intervention
Resting heart rate From baseline to after 7 weeks intervention
Cholesterol in blood From baseline to after 7 weeks intervention
High density lipoprotein cholesterol in blood From baseline to after 7 weeks intervention
Low density lipoprotein cholesterol in blood From baseline to after 7 weeks intervention
Triglycerides in blood From baseline to after 7 weeks intervention
Average glucose levels From baseline to after 7 weeks intervention
Insulinemia From baseline to after 7 weeks intervention
24 hour glycaemic control From baseline to the last 14 days of the intervention period
Postprandial glycaemic control From baseline to the last 14 days of the intervention period
Nocturnal glycaemic control From baseline to the last 14 days of the intervention period
Self-reported physical activity From baseline to after 7 weeks intervention
Measured physical activity From baseline to the last 14 days of the intervention period
Sleep From baseline to after 7 weeks intervention
Chronotype From baseline to after 7 weeks intervention
Enrollment 116
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: High Intensity Interval Training

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

Intervention Type: Behavioral

Intervention Name: Time-Restricted Eating

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

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.

Gender: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Trine T Moholdt, PhD

Phone: +4797098594

Email: [email protected]

Location
Facility: Status: Contact: Department of circulation and medical imaging , NTNU Trine Moholdt, phd 0047 97098594 [email protected]
Location Countries

Norway

Verification Date

May 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: High Intensity Interval Training

Type: Experimental

Description: High intensity interval training for seven weeks. Three weekly, supervised training sessions.

Label: Time-Restricted Eating

Type: Experimental

Description: Time-restricted eating for seven weeks. Maximal daily eating window of 10 hours.

Label: High Intensity Interval Training & Time-Restricted Eating

Type: Experimental

Label: Control

Type: No Intervention

Description: Will be given information about the recommended level of physical activity for health benefits and a healthy diet.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Four-armed randomised controlled trial

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov