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

NCT07036562 | Recruiting

• 1 other identifier: 911308
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

time-restricted eating; high-intensity interval training; exercise; diet; metabolic health; lifestyle intervention

Outcome Measures

Primary Outcomes (1)

• Total fat mass

  Change in total fat mass measured with bioelectrical impedance analysis

  From baseline to after 12 months

Secondary Outcomes (19)

• Blood glucose

  From baseline to after 6 months and after 12 months

• Total fat mass

  From baseline to after 6 months

• Insulin

  From baseline to after 6 months and after 12 months

• Average glucose levels

  From baseline to after 6 months and after 12 months

• Blood cholesterol

  From baseline to after 6 months and after 12 months

Other Outcomes (6)

• Adherence to high-intensity interval training

  12 months

• Compliance to high-intensity interval training

  12 months

• Adherence to time-restricted eating

  During baseline week, after 4, 13, 30, and 50 weeks.

Study Arms (2)

Time-restricted eating and high-intensity interval training

EXPERIMENTAL

12 months of periodised time-restricted eating and high-intensity interval training with digital follow-up

Behavioral: Time-restricted eating and high-intensity interval training

Control

NO INTERVENTION

No intervention or follow-up. Habitual lifestyle

Interventions

Time-restricted eating and high-intensity interval training BEHAVIORAL

1-month intense periods of maximal daily eating window of 10 hours and high-intensity interval training (three weekly, unsupervised, aerobic exercise sessions performed at \> 90 % heart rate maximum), separated by 3-month maintenance periods of time-restricted eating on 5 days per week and minimum 1 HIIT session per week. Each exercise session will last for 33-38 minutes. Participants will receive digital follow-up once weekly during intense periods, and once monthly during maintenance periods. The intervention period will be 12 months in total.

Time-restricted eating and high-intensity interval training

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead

Study Sites (1)

Department of circulation and medical imaging, NTNU

Trondheim, 7491, Norway

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Intermittent Fasting; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Kamilla La Haganes, PhD

CONTACT

+4747316765; kamilla.l.haganes@ntnu.no

Trine Moholdt, PhD

CONTACT

+4797098594; trine.moholdt@ntnu.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: The data will become available at the time of publication of the results from the study.
• Access Criteria: Open access

Locations

NO (1)