Obstructive Sleep ApneaNCT01985035
Influence of Obstructive Sleep Apnea on Metabolism and Weight Loss in Obese Individuals
A study testing Diet in people with Obstructive Sleep Apnea and Obesity, run by Federal University of São Paulo at 2 sites in Brazil.
Trial summary
Obstructive sleep apnea (OSA) can impars body weight reduction by changes in body composition and energy expenditure. The objective of this study is to evaluate the influence of OSA in energy metabolism and body mass loss in obese subjects. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Obesity
- What is being tested?
- Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesBrazil
- Study dates
- Oct 2013to Aug 2015
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index between 30 and 40 kg/m2;
- Obstructive sleep apnea mild or severe;
- Sedentary.
Who cannot join
- Intake of any drug that interfere on metabolism such for thyroid or to lose weight;
- Be engaged in other treatment for sleep apnea or obesity;
- Present another sleep disorder;
- Being shift work;
- Present any kind of kidney disease.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Departamento de Psicobiologia - Universidade Federal de São Paulo
São Paulo, São Paulo, 04023-062
Universidade Federal de São Paulo
São Paulo, São Paulo, 04024-002
About this study
Obstructive sleep apnea (OSA) can impars body weight reduction by changes in body composition and energy expenditure. The objective of this study is to evaluate the influence of OSA in energy metabolism and body mass loss in obese subjects. Ninety obese volunteers of both genders, 45 diagnosed with OSA and 45 without OSA, will be submitted to a dietary intervention of one months. Volunteers will be distributed into four groups: obese OSA PTN with moderate protein diet (1.6 g / kg protein / day), obese OSA CHO diet (0.8 g / kg protein / day) with standard composition diet, obese NSAOS PTN diet moderate in protein and CHO NSAOS obese standard diet. All groups will be instructed to perform a restricted energy diet (less 30% of daily energy expenditure). At baseline and one month after the beginning of the program the following evaluations will be conducted: total energy expenditure measured by doubly labeled water method, resting energy expenditure and thermic effect of food by calorimetry, polysomnography analysis, body composition by pletysmography, food consumption by three days of food diary, blood collection for analysis of lipid profile, visceral proteins, hormones related to control of body weight and inflammation. As hypothesis we believe that apneic obese individuals have greater difficult in weight loss and loss more free fat mass than the obese no apneic and that diets with more protein can contribute to greater weight loss, better body composition and energy expenditure in these population.
- Conditions
- Obstructive Sleep Apnea, Obesity
- Being tested
- Diet
- Keywords
- Obstructive sleep apnea, obesity, diet, energy expenditure
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
Also called Energy restriction
Reduction of energy intake in order to weight loss
| Study group | Role | What they receive |
|---|---|---|
| Obese Apneic carbohydrate diet | Experimental | Obese apneic individuals will be subject to a energy restriction diet rich in carbohydrates Receives: Behavioral: Diet |
| Obese Apneic protein diet | Experimental | Obese apneic individuals will be subject to a energy restricted diet rich in protein Receives: Behavioral: Diet |
| Obese Non Apneic carbohydrate diet | Experimental | Obese individuals without Obstructive sleep apnea will be subjected to a energy restricted diet rich in carbohydrates Receives: Behavioral: Diet |
| Obese Non Apneic protein diet | Experimental | Obese individuals without Obstructive Sleep Apnea will be subjected to a energy restricted diet rich in protein Receives: Behavioral: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure
Measurements of energy expenditure by doubly labeled water for day energy expenditure and by calorimetry for resting energy expenditure and thermic effect of food
Measured: up to 4 months
Secondary outcomes (1)
Body Composition
Bodu composition evaluation by pletismografy to determine fat mass and fat free mass
Measured: Baseline, 1 month, 2 months and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Camila Maria de Melo, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985035
- Sponsor's protocol ID
- RMR-PRO
- Status last verified
- Jul 2016
- First submitted
- 4 Nov 2013
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
de Melo CM, Dos Santos Quaresma MVL, Del Re MP, Ribeiro SML, Moreira Antunes HK, Togeiro SM, Tufik S, de Mello MT. One-month of a low-energy diet, with no additional effect of high-protein, reduces Obstructive Sleep Apnea severity and improve metabolic parameters in obese males. Clin Nutr ESPEN. 2021 Apr;42:82-89. doi: 10.1016/j.clnesp.2020.12.028. Epub 2021 Feb 11.
PubMed 33745625
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Obstructive Sleep Apnea on Metabolism and Weight Loss in Obese Individuals
- ClinicalTrials.gov ID
- NCT01985035
- Acronym / sponsor ID
- RMR-PRO
- Conditions
- Obstructive Sleep Apnea, Obesity
- Keywords
- Obstructive sleep apnea, obesity, diet, energy expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Oct 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 15 Nov 2013 (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.
Obstructive sleep apnea (OSA) can impars body weight reduction by changes in body composition and energy expenditure. The objective of this study is to evaluate the influence of OSA in energy metabolism and body mass loss in obese subjects. Ninety obese volunteers of both genders, 45 diagnosed with OSA and 45 without OSA, will be submitted to a dietary intervention of one months. Volunteers will be distributed into four groups: obese OSA PTN with moderate protein diet (1.6 g / kg protein / day), obese OSA CHO diet (0.8 g / kg protein / day) with standard composition diet, obese NSAOS PTN diet moderate in protein and CHO NSAOS obese standard diet. All groups will be instructed to perform a restricted energy diet (less 30% of daily energy expenditure). At baseline and one month after the beginning of the program the following evaluations will be conducted: total energy expenditure measured by doubly labeled water method, resting energy expenditure and thermic effect of food by calorimetry, polysomnography analysis, body composition by pletysmography, food consumption by three days of food diary, blood collection for analysis of lipid profile, visceral proteins, hormones related to control of body weight and inflammation. As hypothesis we believe that apneic obese individuals have greater difficult in weight loss and loss more free fat mass than the obese no apneic and that diets with more protein can contribute to greater weight loss, better body composition and energy expenditure in these population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obese Apneic carbohydrate diet | Experimental | Behavioral: DietObese apneic individuals will be subject to a energy restriction diet rich in carbohydrates |
| Obese Apneic protein diet | Experimental | Behavioral: DietObese apneic individuals will be subject to a energy restricted diet rich in protein |
| Obese Non Apneic carbohydrate diet | Experimental | Behavioral: DietObese individuals without Obstructive sleep apnea will be subjected to a energy restricted diet rich in carbohydrates |
| Obese Non Apneic protein diet | Experimental | Behavioral: DietObese individuals without Obstructive Sleep Apnea will be subjected to a energy restricted diet rich in protein |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body Mass Index between 30 and 40 kg/m2;
- Obstructive sleep apnea mild or severe;
- Sedentary.
Key exclusion criteria (5 listed)
- Intake of any drug that interfere on metabolism such for thyroid or to lose weight;
- Be engaged in other treatment for sleep apnea or obesity;
- Present another sleep disorder;
- Being shift work;
- Present any kind of kidney disease.
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 |
|---|---|---|
| DietAlso: Energy restrictionReduction of energy intake in order to weight loss | Behavioural | Obese Apneic carbohydrate diet, Obese Apneic protein diet, Obese Non Apneic carbohydrate diet, Obese Non Apneic protein diet |
Primary outcome
Energy expenditure
Time frame: up to 4 months
Measurements of energy expenditure by doubly labeled water for day energy expenditure and by calorimetry for resting energy expenditure and thermic effect of food
1 secondary outcome
Body Composition
Time frame: Baseline, 1 month, 2 months and 4 months
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 4 Jul 2016.
- Derived from this study: PubMed 33745625de Melo CM, Dos Santos Quaresma MVL, Del Re MP, Ribeiro SML, Moreira Antunes HK, Togeiro SM, Tufik S, de Mello MT. One-month of a low-energy diet, with no additional effect of high-protein, reduces Obstructive Sleep Apnea severity and improve metabolic parameters in obese males. Clin Nutr ESPEN. 2021 Apr;42:82-89. doi: 10.1016/j.clnesp.2020.12.028. Epub 2021 Feb 11.
- Individual participant dataSharing planned: Undecided
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RecruitingObservational study
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Obstructive Sleep Apnea and Obesity, run by Federal University of São Paulo at 2 sites 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 3 inclusion and 5 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 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Energy expenditure (time frame: up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01985035, which also lists 1 linked publication.
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 4 Jul 2016.