Time-restricted Eating and High Intensity Interval Training Among Women

NCT ID: NCT04019860

Last Updated: 2021-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-12

Study Completion Date

2021-03-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity; Endocrine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Four-armed randomised controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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High Intensity Interval Training

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

Group Type EXPERIMENTAL

High Intensity Interval Training

Intervention Type BEHAVIORAL

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

Time-Restricted Eating

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

Group Type EXPERIMENTAL

Time-Restricted Eating

Intervention Type BEHAVIORAL

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

High Intensity Interval Training & Time-Restricted Eating

Group Type EXPERIMENTAL

High Intensity Interval Training

Intervention Type BEHAVIORAL

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

Time-Restricted Eating

Intervention Type BEHAVIORAL

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Time-Restricted Eating

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Australian Catholic University

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Øystein T Risa, PhD

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Trine T Moholdt, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

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Department of circulation and medical imaging , NTNU

Trondheim, , Norway

Site Status

Countries

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Norway

References

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Haganes KL, Devlin BL, Orr RK, Moholdt T. Impact of Time-Restricted Eating and High-Intensity Exercise on Nutrient Intake in Women with Overweight/Obesity: Secondary Analysis of a Randomized Controlled Trial. Nutrients. 2025 Jan 8;17(2):218. doi: 10.3390/nu17020218.

Reference Type DERIVED
PMID: 39861348 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36198292 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33550228 (View on PubMed)

Other Identifiers

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285171

Identifier Type: OTHER

Identifier Source: secondary_id

2019/851

Identifier Type: -

Identifier Source: org_study_id

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