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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01096836
Other study ID # UGF-01-2010
Secondary ID
Status Completed
Phase N/A
First received March 17, 2010
Last updated March 30, 2010
Start date September 2006
Est. completion date August 2008

Study information

Verified date November 2007
Source Universidade Gama Filho
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date August 2008
Est. primary completion date January 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
macronutrient and energy manipulation


Locations

Country Name City State
Brazil Laboratory Crossbridges Rio de Janeiro RJ

Sponsors (1)

Lead Sponsor Collaborator
Universidade Gama Filho

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary body mass Measured always at the same time of the day on a calibrated weight scale eight weeks No
Secondary Muscle strength Measured using resistance exercise machines (isotonic) in four exercise movements eight weeks No
Secondary 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. eight weeks
Secondary 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. eight weeks
Secondary markers of renal function Measured using conventional and satandardized laboratory methods with subjects fasting for 12 hours eight weeks
Secondary body composition Measured with skinfold calipers and using prediction equations to determine body fat and lean body mass. eight weeks
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