ObesityLCD-RTNCT01096836
Low Carbohydrate and Conventional Diets Associated to Resistance Training on Muscle Fitness and Health Markers
A study testing macronutrient and energy manipulation in people with Obesity and Overweight, run by Universidade Gama Filho at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- macronutrient and energy manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2006to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI equal or over 25 kg/m2
- resistance trained at least 12 weeks
Who cannot join
- upper or lower limbs injury
- pregnancy
- diabetes
- use of ergogenics, stimulants or drugs
- history of dislipidemias
- arterial hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Overweight
- Being tested
- macronutrient and energy manipulation
- Keywords
- resistance exercise, body mass index, hypertrophy, endothelial function, blood lipids
- Medical subject headings
- Obesity, Overweight, Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
macronutrient and energy manipulationOther
| Study group | Role | What they receive |
|---|---|---|
| Diet counseling | Experimental | Outcomes of the study may enhance diet counseling Receives: Other: macronutrient and energy manipulation |
| exercise training | Experimental | Not described Receives: Other: macronutrient and energy manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass
Measured always at the same time of the day on a calibrated weight scale
Measured: eight weeks
Secondary outcomes (5)
Muscle strength
Measured using resistance exercise machines (isotonic) in four exercise movements
Measured: eight weeks
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.
Measured: eight weeks
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.
Measured: eight weeks
markers of renal function
Measured using conventional and satandardized laboratory methods with subjects fasting for 12 hours
Measured: eight weeks
body composition
Measured with skinfold calipers and using prediction equations to determine body fat and lean body mass.
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startSep 2006
- Primary completionJan 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Gama Filho
- Sponsor type
- University, hospital or other
- Investigators
- Paulo Sergio C Gomes, Ph.D., Principal investigator, Universidade Gama Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096836
- Sponsor's protocol ID
- UGF-01-2010
- Acronym
- LCD-RT
- Status last verified
- Nov 2007
- First submitted
- 17 Mar 2010
- Last updated
- 31 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Resistance Training and Low Carbohydrate or Conventional Diets on Strength, Muscle Mass, Body Composition, Blood Lipids and Endothelium Function
- ClinicalTrials.gov ID
- NCT01096836
- Acronym / sponsor ID
- LCD-RT / UGF-01-2010
- Conditions
- Obesity, Overweight
- Keywords
- resistance exercise, body mass index, hypertrophy, endothelial function, blood lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Universidade Gama FilhoUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet counseling | Experimental | Other: macronutrient and energy manipulationOutcomes of the study may enhance diet counseling |
| exercise training | Experimental | Other: macronutrient and energy manipulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI equal or over 25 kg/m2
- resistance trained at least 12 weeks
Key exclusion criteria (6 listed)
- upper or lower limbs injury
- pregnancy
- diabetes
- use of ergogenics, stimulants or drugs
- history of dislipidemias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| macronutrient and energy manipulation | Other | Diet counseling, exercise training |
Primary outcome
body mass
Time frame: eight weeks
Measured always at the same time of the day on a calibrated weight scale
5 secondary outcomes
Muscle strength
Time frame: eight weeks
Endothelial function
Time frame: eight weeks
muscle thicknesses
Time frame: eight weeks
markers of renal function
Time frame: eight weeks
body composition
Time frame: eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulo Sergio C Gomes, Ph.D. principal investigator
Universidade Gama Filho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing macronutrient and energy manipulation in people with Obesity and Overweight, run by Universidade Gama Filho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body mass (time frame: eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2010.