NCT04039685

Brief Summary

Obesity is characterized by excessive white adipose tissue (WAT) that increases risk for disease. About 700 million adults are obese worldwide, designating the need of reducing excessive WAT in humans and subsequently the risk for disease. For this reason, previous research focused on the thermogenic capacity of white adipocytes in response to chronic exercise. It is suggested that the latter occurs due to increased demand of oxidation during exercise to maintain non-esterified fatty acids flux in the circulation, thus to maintain energy supply White adipocytes express the uncoupling protein one (UCP1), which dissipates chemical energy in the mitochondria to produce heat in response to cold exposure. UCP1 was thought that exclusively appears in brown adipose tissue (BAT), which during the mitochondrial electron transport chain process, bypasses the adenosine triphosphate (ATP) synthase to produce heat, as a thermoregulatory mechanism of maintaining body temperature. Its presence in white adipocytes, indicates a thermogenic capacity of WAT, which could lead to similar health benefits as those reported for increased BAT activity; mainly reduced body mass index (BMI) and fat mass, which designate body weight loss and reduced obesity phenotype. The investigators aimed to identify whether UCP1 in human WAT is altered by chronic exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2014

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

12 months

First QC Date

July 26, 2019

Last Update Submit

July 30, 2019

Conditions

Keywords

uncoupling protein 1uncoupling protein oneresistance exerciseaerobic exercisebrowning formationwhite fat

Outcome Measures

Primary Outcomes (2)

  • UCP1 mRNA expression in white adipocytes

    UCP1 mRNA expression was measured via fat biopsy samples from the subcutaneous abdominal area at baseline, at the end of the exercise intervention (8th week) and at the end of the de-training period (16th week)

    Baseline measurements; measurements at the end of the exercise intervention (8th week); measurements at the end of the de-training period (16th week)

  • UCP1 protein concentration in white adipocytes

    UCP1 protein concentration was measured via fat biopsy samples from the subcutaneous abdominal area at baseline, at the end of the exercise intervention (8th week) and at the end of the de-training period (16th week)

    Baseline measurements; measurements at the end of the exercise intervention (8th week); measurements at the end of the de-training period (16th week)

Study Arms (4)

Aerobic exercise group

EXPERIMENTAL
Other: Effects of an eight weeks aerobic exercise followed by an eight weeks de-training period on UCP1 gene of human white adipose tissue

Resistance exercise group

EXPERIMENTAL
Other: Effects of an eight weeks resistance exercise followed by an eight weeks de-training period on UCP1 gene of human white adipose tissue

Combined (aerobic+resistance) exercise group

EXPERIMENTAL
Other: Effects of an eight weeks combined (aerobic+resistance) exercise followed by an eight weeks de-training period on UCP1 gene of human white adipose tissue

Non-exercise group

NO INTERVENTION

Interventions

The investigators evaluated the effects of an eight weeks aerobic exercise program and a following of eight weeks of a de-training period on UCP1 gene in previously non-regular exercisers healthy adult men

Aerobic exercise group

The investigators evaluated the effects of an eight weeks resistance exercise program and a following of eight weeks of a de-training period on UCP1 gene in previously non-regular exercisers healthy adult men

Resistance exercise group

The investigators evaluated the effects of an eight weeks combined (aerobic+resistance) exercise program and a following of eight weeks of a de-training period on UCP1 gene in previously non-regular exercisers healthy adult men

Combined (aerobic+resistance) exercise group

Eligibility Criteria

Age18 Years - 55 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • adult men
  • healthy
  • no chronic disease
  • no medication treatment
  • no regular exercisers

You may not qualify if:

  • women
  • non-adult men
  • chronic disease individuals
  • any medication treatment
  • acute illness
  • regular exercisers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Petros Dinas

Trikala, Thessaly, 42100, Greece

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Researcher in human physiology

Study Record Dates

First Submitted

July 26, 2019

First Posted

July 31, 2019

Study Start

June 1, 2013

Primary Completion

May 30, 2014

Study Completion

June 30, 2014

Last Updated

July 31, 2019

Record last verified: 2019-07

Locations