Spot Reduction in Male Adults

March 31, 2023 updated by: Molde University College

The Assessment of Spot Reduction in Adults Males Following Endurance Training

Spot reduction, referring to local body fat reduction, pertains to subcutaneous adipose tissue utilization from specific body parts during exercise. Its existence has been keenly debated, although generally accepted not to occur during exercise. However, it is based on not only equivocal data - commonly the training protocol typically applied is based on strength rather than endurance training. The investigators sought to test this assumption by utilizing endurance based exercise controlling for energy expenditure and using dual x-ray absorptiometric measures to assess body composition before and after training.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • males
  • ≥ 30 years old
  • classified as overweight (Body mass index ≥ 25 kg ∙ m-2)
  • not participating in regular physical training

Exclusion Criteria:

  • < 30 years old
  • Body mass index < 25 kg ∙ m-2
  • participating in regular physical training

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: abdominal aerobic endurance exercise
Subjects were combining treadmill running at 70% HRmax (27 minutes) with 4x4minutes (30-40% maximal strength, 1RM) of torso rotation and abdominal crunches (57 minutes), 4 d per wk for 10 weeks
Other: Abdominal aerobic endurance exercise
Subjects combined treadmill running at 70% HRmax (27 minutes) with 4x4minutes (30-40% maximal strength, 1RM) of torso rotation and abdominal crunches (57 minutes), 4 days per wk for 10 weeks
Active Comparator: Control group
Subjects performed only treadmill running (45 minutes) at 70% HRmax for 4 d per week for 10 weeks.
Other: Control training intervention
Subjects performed treadmill running (45 minutes) at 70% HRmax 4 days per week for 10 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Trunk fat mass change
Time Frame: Change from pre (baseline) to post test (after 10 weeks)
Fat mass located in trunk (g) measured by dual-energy x-ray absorptiometry
Change from pre (baseline) to post test (after 10 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lower extremity fat mass change
Time Frame: Change from pre (baseline) to post test (after 10 weeks)
Fat mass located in lower extremities (g) measured by dual-energy x-ray absorptiometry
Change from pre (baseline) to post test (after 10 weeks)
Upper extremity fat mass change
Time Frame: Change from pre (baseline) to post test (after 10 weeks)
Fat mass located in upper extremities (g) measured by dual-energy x-ray absorptiometry
Change from pre (baseline) to post test (after 10 weeks)
Total fat mass change
Time Frame: Change from pre (baseline) to post test (after 10 weeks)
Total fat mass (g) measured by dual-energy x-ray absorptiometry
Change from pre (baseline) to post test (after 10 weeks)
Body weight change
Time Frame: Change from pre (baseline) to post test (after 10 weeks)
Change from pre (baseline) to post test (after 10 weeks)
Body mass index change
Time Frame: Change from pre (baseline) to post test (after 10 weeks)
Change from pre (baseline) to post test (after 10 weeks)
Waist circumference (cm) change
Time Frame: Change from pre (baseline) to post test (after 10 weeks)
Change from pre (baseline) to post test (after 10 weeks)
Hip circumference (cm) change
Time Frame: Change from pre (baseline) to post test (after 10 weeks)
Change from pre (baseline) to post test (after 10 weeks)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Trunk lean mass change
Time Frame: Change from pre (baseline) to post test (after 10 weeks)
Lean mass located in trunk (g) measured by dual-energy x-ray absorptiometry
Change from pre (baseline) to post test (after 10 weeks)
Lower extremity lean mass change
Time Frame: Change from pre (baseline) to post test (after 10 weeks)
Lean mass located in lower extremities (g) measured by dual-energy x-ray absorptiometry
Change from pre (baseline) to post test (after 10 weeks)
Upper extremity lean mass change
Time Frame: Change from pre (baseline) to post test (after 10 weeks)
Lean mass located in upper extremities (g) measured by dual-energy x-ray absorptiometry
Change from pre (baseline) to post test (after 10 weeks)
Total lean mass change
Time Frame: Change from pre (baseline) to post test (after 10 weeks)
Total lean mass (g) measured by dual-energy x-ray absorptiometry
Change from pre (baseline) to post test (after 10 weeks)
Maximal oxygen uptake change
Time Frame: Change from pre (baseline) to post test (after 10 weeks)
Maximal oxygen uptake by cardiopulmonary indirect calorimetry
Change from pre (baseline) to post test (after 10 weeks)
Maximal muscle strength change
Time Frame: Change from pre (baseline) to post test (after 10 weeks)
One-repetition maximum (kg) in torso rotation and abdominal crunch
Change from pre (baseline) to post test (after 10 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Molde University College

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Norwegian University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MUCSR12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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