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Low Carbohydrate and Conventional Diets Associated to Resistance Training on Muscle Fitness and Health Markers (LCD-RT)

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ClinicalTrials.gov Identifier: NCT01096836
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : March 31, 2010
Sponsor:
Information provided by:
Universidade Gama Filho

Tracking Information
First Submitted Date  ICMJE March 17, 2010
First Posted Date  ICMJE March 31, 2010
Last Update Posted Date March 31, 2010
Study Start Date  ICMJE September 2006
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2010)
body mass [ Time Frame: eight weeks ]
Measured always at the same time of the day on a calibrated weight scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2010)
  • Muscle strength [ Time Frame: eight weeks ]
    Measured using resistance exercise machines (isotonic) in four exercise movements
  • Endothelial function [ Time Frame: eight weeks ]
    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 [ Time Frame: eight weeks ]
    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 [ Time Frame: eight weeks ]
    Measured using conventional and satandardized laboratory methods with subjects fasting for 12 hours
  • body composition [ Time Frame: eight weeks ]
    Measured with skinfold calipers and using prediction equations to determine body fat and lean body mass.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Carbohydrate and Conventional Diets Associated to Resistance Training on Muscle Fitness and Health Markers
Official Title  ICMJE Combined Effects of Resistance Training and Low Carbohydrate or Conventional Diets on Strength, Muscle Mass, Body Composition, Blood Lipids and Endothelium Function
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Overweight
Intervention  ICMJE Other: macronutrient and energy manipulation
Study Arms  ICMJE
  • Experimental: Diet counseling
    Outcomes of the study may enhance diet counseling
    Intervention: Other: macronutrient and energy manipulation
  • Experimental: exercise training
    Intervention: Other: macronutrient and energy manipulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2010)
21
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01096836
Other Study ID Numbers  ICMJE UGF-01-2010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Paulo Sergio Chagas Gomes, Ph.D., Universidade Gama Filho
Study Sponsor  ICMJE Universidade Gama Filho
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paulo Sergio C Gomes, Ph.D. Universidade Gama Filho
PRS Account Universidade Gama Filho
Verification Date November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP