Low Carbohydrate and Conventional Diets Associated to Resistance Training on Muscle Fitness and Health Markers (LCD-RT)
Primary Purpose
Obesity, Overweight
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
macronutrient and energy manipulation
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring resistance exercise, body mass index, hypertrophy, endothelial function, blood lipids
Eligibility Criteria
Inclusion Criteria:
- BMI equal or over 25 kg/m2
- resistance trained at least 12 weeks
Exclusion Criteria:
- upper or lower limbs injury
- pregnancy
- diabetes
- use of ergogenics, stimulants or drugs
- history of dislipidemias
- arterial hypertension
Sites / Locations
- Laboratory Crossbridges
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Diet counseling
exercise training
Arm Description
Outcomes of the study may enhance diet counseling
Outcomes
Primary Outcome Measures
body mass
Measured always at the same time of the day on a calibrated weight scale
Secondary Outcome Measures
Muscle strength
Measured using resistance exercise machines (isotonic) in four exercise movements
Endothelial function
Measured using a two dimensional color spectral Doppler ultrasound equipped with a 14MHz linear transducer. Subject laid down comfortably in the supine position with the right arm slightly abduced. After locating the brachial artery, the transducer was placed on the anteromedial face of the right arm, perpendicular to the centerline of the arm, 5-10 cm above the antecubital fossa, over the artery.
muscle thicknesses
Measured with a ultrasoundo bidimensional in Mode B, with a 7,5MHz transducer on the anatomical sites knee extensor muscles and elbow flexors and extensors.
markers of renal function
Measured using conventional and satandardized laboratory methods with subjects fasting for 12 hours
body composition
Measured with skinfold calipers and using prediction equations to determine body fat and lean body mass.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01096836
Brief Title
Low Carbohydrate and Conventional Diets Associated to Resistance Training on Muscle Fitness and Health Markers
Acronym
LCD-RT
Official Title
Combined Effects of Resistance Training and Low Carbohydrate or Conventional Diets on Strength, Muscle Mass, Body Composition, Blood Lipids and Endothelium Function
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universidade Gama Filho
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study was to compare the effects of two different diets (low carbohydrate - LCD and conventional - CONV) on body composition, strength performance, muscle mass and biomarkers of health in overweight adults submitted to resistance training (RT). It has been hypothesized that LCD would produce higher rates of weight loss and that both diets would be useful to maintain muscle mass and strength and biomarkers of health.
Detailed Description
Overweight and obesity prevalence has increased worldwide. Current guidelines recommend health behavior modifications, including better eating habits and regular physical activity (including resistance training - RT) as a strategy to control and prevent the problem. Traditionally, diets poor in energy and fat (conventional diets - CONV) have been recommended to promote losses in body and fat masses; however, there has been recently a growing interest in the academic community to investigate the effects of low carbohydrate diet (LCD) on health outcomes, since this kind of diet appears to be more effective for reducing body mass as compared to CONV. Nevertheless, evidences are scarce regarding the effects of LCD associated to RT on body composition, strength performance, blood lipids, endothelium function and other markers of health, demanding the development of clinical trials aiming to determine the combined health effects of these interventions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
resistance exercise, body mass index, hypertrophy, endothelial function, blood lipids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diet counseling
Arm Type
Experimental
Arm Description
Outcomes of the study may enhance diet counseling
Arm Title
exercise training
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
macronutrient and energy manipulation
Primary Outcome Measure Information:
Title
body mass
Description
Measured always at the same time of the day on a calibrated weight scale
Time Frame
eight weeks
Secondary Outcome Measure Information:
Title
Muscle strength
Description
Measured using resistance exercise machines (isotonic) in four exercise movements
Time Frame
eight weeks
Title
Endothelial function
Description
Measured using a two dimensional color spectral Doppler ultrasound equipped with a 14MHz linear transducer. Subject laid down comfortably in the supine position with the right arm slightly abduced. After locating the brachial artery, the transducer was placed on the anteromedial face of the right arm, perpendicular to the centerline of the arm, 5-10 cm above the antecubital fossa, over the artery.
Time Frame
eight weeks
Title
muscle thicknesses
Description
Measured with a ultrasoundo bidimensional in Mode B, with a 7,5MHz transducer on the anatomical sites knee extensor muscles and elbow flexors and extensors.
Time Frame
eight weeks
Title
markers of renal function
Description
Measured using conventional and satandardized laboratory methods with subjects fasting for 12 hours
Time Frame
eight weeks
Title
body composition
Description
Measured with skinfold calipers and using prediction equations to determine body fat and lean body mass.
Time Frame
eight weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI equal or over 25 kg/m2
resistance trained at least 12 weeks
Exclusion Criteria:
upper or lower limbs injury
pregnancy
diabetes
use of ergogenics, stimulants or drugs
history of dislipidemias
arterial hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo Sergio C Gomes, Ph.D.
Organizational Affiliation
Universidade Gama Filho
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory Crossbridges
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20748-900
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Low Carbohydrate and Conventional Diets Associated to Resistance Training on Muscle Fitness and Health Markers
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