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Overweight and ObesityTREHIIT-DFUNCT05505305

Time-restricted Eating and Interval Training With Digital Follow-up

A study testing Time-restricted eating and high-intensity interval training in people with Overweight and Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will investigate the effects of seven weeks of time-restricted eating combined with high-intensity interval training compared with a control group on body composition in adults with overweight/obesity. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Overweight and Obesity
What is being tested?
Time-restricted eating and high-intensity interval training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteNorway
Study dates
1 Sep 2022to 13 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Department of circulation and medical imaging, NTNU

    Trondheim, 7491

Other trials in Norway

About this study

Official title: Effects of Time-restricted Eating and Interval Training With Digital Follow-up: A Randomized Controlled Trial

This study will investigate the effects of seven weeks of time-restricted eating combined with high-intensity interval training compared with a control group on body composition in adults with overweight/obesity. Participants in the intervention group will complete the intervention remotely and will receive weekly follow-up through online platforms (telephone, video call). Before and after the intervention, 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.

Being tested
Time-restricted eating and high-intensity interval training
Keywords
time-restricted eating, high-intensity interval training, exercise, diet, body composition
Medical subject headings
Overweight, Obesity, Intermittent Fasting, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Time-restricted eating and high-intensity interval trainingBehavioural

    Maximal daily eating window of 10 hours and high-intensity interval training (three weekly, unsupervised, aerobic exercise sessions performed at > 90 % heart rate maximum). Each exercise session will last for 33-38 minutes. Participants will receive digital follow-up once weekly. The intervention period will be seven weeks,

Study groups in NCT05505305
Study groupRoleWhat they receive
Time-restricted eating and high-intensity interval trainingExperimentalSeven weeks of time-restricted eating and high-intensity interval training with digital follow-up.
Receives: Behavioral: Time-restricted eating and high-intensity interval training
ControlNo interventionNo intervention nor digital follow-up for seven weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total fat mass

    Change in total fat mass measured with bioelectrical impedance analysis

    Measured: From baseline to after 7 weeks of intervention

Secondary outcomes (21)

  1. Blood glucose

    Fasting concentration of plasma glucose

    Measured: From baseline to after 7 weeks of intervention

  2. Insulin

    Fasting concentration of plasma insulin C-peptide

    Measured: From baseline to after 7 weeks of intervention

  3. Average glucose levels

    Glycated hemoglobin (HbA1c)

    Measured: From baseline to after 7 weeks of intervention

  4. Blood Cholesterol

    Total fasting cholesterol in blood

    Measured: From baseline to after 7 weeks of intervention

  5. HDL-cholesterol in blood

    Fasting high-density lipoprotein-cholesterol in blood

    Measured: From baseline to after 7 weeks of intervention

  6. LDL-cholesterol in blood

    Fasting low-density lipoprotein-cholesterol in blood

    Measured: From baseline to after 7 weeks of intervention

  7. Triglycerides in blood

    Fasting triglycerides in blood

    Measured: From baseline to after 7 weeks of intervention

  8. Insulin sensitivity

    Homeostatic model assessment for insulin resistance (HOMA-IR): 1.5 + fasting plasma glucose (mmol/L) × fasting plasma insulin C-peptide (pmol/L) / 2800

    Measured: From baseline to after 7 weeks of intervention

  9. Cardiorespiratory fitness

    Peak oxygen uptake at a maximum effort exercise test, measured in mL/min/kg and L/min

    Measured: From baseline to after 7 weeks of intervention

  10. Body mass

    In kg, estimated with bioelectrical impedance analysis

    Measured: From baseline to after 7 weeks of intervention

  11. Body fat-free mass

    In kg, estimated with bioelectrical impedance analysis

    Measured: From baseline to after 7 weeks of intervention

  12. Visceral fat area

    In cm², estimated with bioelectrical impedance analysis

    Measured: From baseline to after 7 weeks of intervention

  13. Systolic blood pressure

    Average of three measurements during rest in seated position, in mmHg

    Measured: From baseline to after 7 weeks of intervention

  14. Diastolic blood pressure

    Average of three measurements during rest in seated position, in mmHg

    Measured: From baseline to after 7 weeks of intervention

  15. Resting heart rate

    Average of three measurements during rest in sitting position, in beats/min

    Measured: From baseline to after 7 weeks of intervention

  16. Physical activity level

    International Physical Activity Questionnaire, categorical score

    Measured: From baseline to after 7 weeks of intervention

  17. Self-reported physical activity

    Self-reported duration and intensity of daily physical activity during baseline week, first week of intervention, and last week of intervention, in metabolic equivalent of task (MET)/week

    Measured: 7 days at baseline, 7 days at start of intervention, 7 days at end of intervention.

  18. Diet intake

    Online food diary during baseline week, first week of intervention, and last week of intervention, in kilojoules (kJ)/week

    Measured: 7 days at baseline, 7 days at start of intervention, 7 days at end of intervention.

  19. Sleep quality

    The Pittsburgh Sleep Quality Index questionnaire

    Measured: From baseline to after 7 weeks of intervention

  20. Sleep duration

    Self-reported hours of sleep per night during baseline week, first week of intervention, and last week of intervention, average hours/night

    Measured: 7 days at baseline, 7 days at start of intervention, 7 days at end of intervention

  21. Appetite

    Self-reported ratings of hunger/satiety on visual analogue scale upon waking and before bedtime during baseline week, first week of intervention, and last week of intervention, average hours/night

    Measured: 7 days at baseline, 7 days at start of intervention, 7 days at end of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2022
  2. Study start1 Sep 2022
  3. Primary completion13 May 2024
  4. Study completion13 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05505305
Sponsor's protocol ID
479143
Acronym
TREHIIT-DFU
Status last verified
Jun 2024
First submitted
16 Aug 2022
Last updated
21 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Time-restricted eating and high-intensity interval training in people with Overweight and Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total fat mass (time frame: From baseline to after 7 weeks of intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05505305.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.

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