Time-restricted Eating and High-intensity Interval Training for Metabolic Health in Adults With Overweight/Obesity

Not Applicable

Not yet recruiting

• Conditions: Overweight and Obesity

• Registration Number: NCT07036562
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

This study will investigate the effects of 12 months periodised time-restricted eating combined with high-intensity interval training compared with a control group on fat mass in adults with overweight/obesity. Participants in the intervention group will complete the intervention remotely and will receive follow-up by telephone. Before randomisation, after 6 months and after 12 months, the investigators will measure the participants' body composition, physical fitness, fasting blood glucose and insulin, blood lipids, and blood pressure. Physical activity, diet, sleep quality, appetite, and adherence to the intervention will also be measured. Secondary sub-analyses of sex differences in the responses to the intervention will be performed.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-17
• Study First Submitted QC: 2025-06-17
• Study First Posted: 2025-06-25
• Last Update Submitted: 2025-06-27
• Last Update Posted: 2025-07-01
• Study Start: 2025-08-01
• Primary Completion: 2027-07
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Body mass index ≥ 27 kg/m²
• Able to walk or ride a bike > 60 min

Exclusion Criteria

• On-going pregnancy
• Lactation within 24 weeks of study commencement
• High-intensity exercise ≥ 1/week
• Habitual eating window ≤12 hours/day
• Taking hypertension, glucose-, or lipid-lowering drugs
• Body mass variation ≥ 4 kg three months prior to study commencement
• Known diabetes mellitus (type 1 or 2) or cardiovascular disease
• Working night shifts

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total fat mass	From baseline to after 12 months	Change in total fat mass measured with bioelectrical impedance analysis

Secondary Outcome Measures

Name	Time	Method
Diastolic blood pressure	From baseline to after 6 months and after 12 months	Average of three measurements during rest in seated position, in mmHg
Blood glucose	From baseline to after 6 months and after 12 months	Fasting concentration of plasma glucose
Total fat mass	From baseline to after 6 months	Change in total fat mass measured with bioelectrical impedance analysis
Insulin	From baseline to after 6 months and after 12 months	Fasting concentration of plasma insulin C-peptide
Average glucose levels	From baseline to after 6 months and after 12 months	Glycated haemoglobin (HbA1c)
Blood cholesterol	From baseline to after 6 months and after 12 months	Total fasting cholesterol in blood
LDL-cholesterol	From baseline to after 6 months and after 12 months	Fasting low-density lipoprotein-cholesterol in blood
HDL-cholesterol	From baseline to after 6 months and after 12 months	Fasting high-density lipoprotein-cholesterol in blood
Triglycerides	From baseline to after 6 months and after 12 months	Fasting triglycerides in blood
Cardiorespiratory fitness	From baseline to after 6 months and after 12 months	Peak oxygen uptake at a maximum effort test, measured in mL/min/kg and L/min
Insulin sensitivity	From baseline to after 6 months and after 12 months	Homeostatic model assessment for insulin resistance (HOMA-IR): 1.5 + fasting plasma glucose (mmol/L) x fasting plasma insulin C-peptide (pmol/L)/2800
Body mass	From baseline to after 6 months and after 12 months	In kg, estimated with bioelectrical impedance analysis
Fat-free mass	From baseline to after 6 months and after 12 months	In kg, estimated with bioelectrical impedance analysis
Visceral fat area	From baseline to after 6 months and after 12 months	In cm2, estimated with bioelectrical impedance analysis
Systolic blood pressure	From baseline to after 6 months and after 12 months	Average of three measurements during rest in seated position, in mmHg
Resting heart rate	From baseline to after 6 months and after 12 months	Average of three measurements during rest in sitting position, in beats/min
Physical activity levels	From baseline to after 6 months and after 12 months	International Physical Activity Questionnaire
Diet intake	During baseline week, after 4, 13, 30, and 50 weeks.	3-day diet diaries (two weekdays and one weekend day) with online diet diary.
Sleep quality	From baseline to after 6 months and after 12 months	The Pittsburgh Sleep Quality Index questionnaire

Trial Locations

Locations (1)

Department of circulation and medical imaging, NTNU; 🇳🇴 Trondheim, Norway