Investigation of Fat Oxidation During Moderate Versus Vig... | NCT03864679

Studies
Investigation of Fat Oxidation During Moderate Versus Vigorous Intensity Exercise

NCT03864679

Sponsor

Latvian Institute of Organic Synthesis

Status

Completed

Last Update Posted

Mar 6, 2019Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Healthy
Sedentary Lifestyle

Interventions

Exercise

Countries

Latvia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 18, 2018Actual

Primary Completion Date

Aug 15, 2018Actual

Completion Date

Aug 30, 2018Actual

First Submitted Date

Jun 22, 2018

First Submission Date that Met QC Criteria

Mar 5, 2019

First Posted Date

Mar 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2019

Last Update Posted Date

Mar 6, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Latvian Institute of Organic SynthesisOTHER

Collaborators

Name	Class
Riga East University Hospital	UNKNOWN
University of Latvia	OTHER
Riga Stradins University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

It is planned to recruit 12 healthy volunteers with a sedentary lifestyle in the study group. Since different regimens (fed, fasted and moderate versus vigorous) will be compared in the same subjects, no control group is necessary. 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 after the incremental intensity exercise). The expiration of carbon dioxide (CO2) and consumption of oxygen (O2) will be measured, to determine the total fatty acid and carbohydrate oxidation during cycling. Concomitantly, it is planned to measure blood lactate and glucose concentrations during exercise experiments as well as a wide range of blood biochemistry parameters before and after exercise.

The investigators expect to find optimal conditions for the sedentary population for burning of fat, which is the major source of energy during moderate-intensity exercise. Measurements of the fat and carbohydrate oxidation in healthy volunteers with a sedentary lifestyle will contribute to the understanding of exercise regimens for the most effective fat oxidation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise	Experimental	Subjects will perform a cycling tests	Other: Exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise	Other	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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Influence of fed and fasted state	The influence of fed and fasted state on maximal whole body fat oxidation rate during exercise	30 min accelerated load cycling exercise

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ilze Konrade	Riga East University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Latvian University		Riga		LV-1004	Latvia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Apr 8, 2019
Reset	Jun 28, 2019

Submission Tracking

Estimated Results First Submitted Date

Apr 8, 2019

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 8, 2019			Jun 28, 2019

Condition Browse Module

MeSH Terms

ID	Term
D057185	Sedentary Behavior
D009043	Motor Activity
D007863	Lecithin Cholesterol Acyltransferase Deficiency
C564245	Platelet Glycoprotein IV Deficiency

Ancestor Terms

ID	Term
D001519	Behavior
D052456	Hypoalphalipoproteinemias
D007009	Hypolipoproteinemias
D008052	Lipid Metabolism, Inborn Errors

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided