NCT01096836

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 31, 2010

Completed
Last Updated

March 31, 2010

Status Verified

November 1, 2007

Enrollment Period

1.3 years

First QC Date

March 17, 2010

Last Update Submit

March 30, 2010

Conditions

ObesityOverweight

Keywords

resistance exercisebody mass indexhypertrophyendothelial functionblood lipids

Outcome Measures

Primary Outcomes (1)

  • body mass

    Measured always at the same time of the day on a calibrated weight scale

    eight weeks

Secondary Outcomes (5)

  • Muscle strength

    eight weeks

  • Endothelial function

    eight weeks

  • muscle thicknesses

    eight weeks

  • markers of renal function

    eight weeks

  • body composition

    eight weeks

Study Arms (2)

Diet counseling

EXPERIMENTAL

Outcomes of the study may enhance diet counseling

Other: macronutrient and energy manipulation

exercise training

EXPERIMENTAL
Other: macronutrient and energy manipulation

Interventions

macronutrient and energy manipulationOTHER
Diet counselingexercise training

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI equal or over 25 kg/m2
  • resistance trained at least 12 weeks

You may not qualify if:

  • upper or lower limbs injury
  • pregnancy
  • diabetes
  • use of ergogenics, stimulants or drugs
  • history of dislipidemias
  • arterial hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory Crossbridges

Rio de Janeiro, Rio de Janeiro, 20748-900, Brazil

Location

MeSH Terms

Conditions

ObesityOverweightHypertrophy

Interventions

Nutrients

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Paulo Sergio C Gomes, Ph.D.

    Universidade Gama Filho

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 17, 2010

First Posted

March 31, 2010

Study Start

September 1, 2006

Primary Completion

January 1, 2008

Study Completion

August 1, 2008

Last Updated

March 31, 2010

Record last verified: 2007-11

Locations

BR(1)