- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01096836
Low Carbohydrate and Conventional Diets Associated to Resistance Training on Muscle Fitness and Health Markers (LCD-RT)
March 30, 2010 updated by: Universidade Gama Filho
Combined Effects of Resistance Training and Low Carbohydrate or Conventional Diets on Strength, Muscle Mass, Body Composition, Blood Lipids and Endothelium Function
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RJ
-
Rio de Janeiro, RJ, Brazil, 20748-900
- Laboratory Crossbridges
-
-
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
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
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: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: exercise training
|
|
Experimental: Diet counseling
Outcomes of the study may enhance diet counseling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
body mass
Time Frame: eight weeks
|
Measured always at the same time of the day on a calibrated weight scale
|
eight weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle strength
Time Frame: eight weeks
|
Measured using resistance exercise machines (isotonic) in four exercise movements
|
eight weeks
|
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.
|
eight weeks
|
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.
|
eight weeks
|
markers of renal function
Time Frame: eight weeks
|
Measured using conventional and satandardized laboratory methods with subjects fasting for 12 hours
|
eight weeks
|
body composition
Time Frame: eight weeks
|
Measured with skinfold calipers and using prediction equations to determine body fat and lean body mass.
|
eight weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paulo Sergio C Gomes, Ph.D., Universidade Gama Filho
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
September 1, 2006
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
March 17, 2010
First Submitted That Met QC Criteria
March 30, 2010
First Posted (Estimate)
March 31, 2010
Study Record Updates
Last Update Posted (Estimate)
March 31, 2010
Last Update Submitted That Met QC Criteria
March 30, 2010
Last Verified
November 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UGF-01-2010
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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