NCT03864679

Brief Summary

Exercise is widely suggested as an important lifestyle change for weight loss, however, the optimal level of intensity moderate versus vigorous remains unclear. It is known that in athletes, during very high-intensity exercise, fat oxidation is decreased and energy is gained mainly from carbohydrate utilization. The aim of this study is to find an optimal workload based on fat oxidation rate during exercise in volunteers with a sedentary lifestyle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

2 months

First QC Date

June 22, 2018

Last Update Submit

March 5, 2019

Conditions

Keywords

exercisefedfastedfatcarbohydrate

Outcome Measures

Primary Outcomes (2)

  • Optimal workload

    The exercise workload (W) for optimal fat burning during exercise

    30 min accelerated load cycling exercise

  • Heart rate change

    Change in heart rate (BPM) from rest to the optimal workload

    30 min accelerated load cycling exercise and 60 min optimal intensity cycling exercise

Secondary Outcomes (1)

  • Influence of fed and fasted state

    30 min accelerated load cycling exercise

Study Arms (1)

Exercise

EXPERIMENTAL

Subjects will perform a cycling tests

Other: Exercise

Interventions

Subjects will perform a cycling test with 5 min incremental intensity exercise and 1 h cycling test exercising at a moderate-intensity (load will be selected in incremental intensity exercise).

Exercise

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Sedentary lifestyle
  • BMI 20 - 30 kg/m2
  • Be able to attend the laboratory and willing to participate in necessary protocols
  • Be willing to undertake the duration of the exercise protocol (3 x 1 hour)
  • Have the capacity and willingness to provide informed consent (oral and written)

You may not qualify if:

  • athletes
  • Individuals with chronic cardiovascular disease such as hypertension, valve disease, coronary artery disease, cardiac conduction abnormalities, etc.
  • History of pneumothorax or chronic lung disease such as asthma, COPD, bronchiectasis
  • Active Smokers
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Latvian University

Riga, LV-1004, Latvia

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor ActivityLecithin Cholesterol Acyltransferase DeficiencyPlatelet Glycoprotein IV Deficiency

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorHypoalphalipoproteinemiasHypolipoproteinemiasLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ilze Konrade

    Riga East University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2018

First Posted

March 6, 2019

Study Start

June 18, 2018

Primary Completion

August 15, 2018

Study Completion

August 30, 2018

Last Updated

March 6, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations