Sleep ApneaMedOOSANCT03514199
Mediterranean-type Diet for Older Adults With Obstructive Sleep Apnea
A study testing Mediterranean-type diet and Low fat diet in people with Sleep Apnea, run by Hospital de Clinicas de Porto Alegre.
Trial summary
The majority of the elderly present with sleep apnea and mortality is significantly higher in this group. Sleep apnea runs the risk of developing diseases, especially hypertension and cardiovascular disease, while the Mediterranean diet is associated with reduced risk. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Mediterranean-type diet and Low fat diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 31 Dec 2019
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Agreement to sign the ICF;
- AHI between 15 and 50 events/h;
- Age between 65 and 80 years;
- Both sexes;
- BMI between 27-39.9 kg / m2.
Who cannot join
- In treatment for sleep apnea;
- Predominantly central sleep apnea;
- Feed predominantly of meals provided by third parties;
- Gastrointestinal disease, with intolerance to fat intake;
- Impossibility to follow the Mediterranean diet due to the presence of mastication and/or swallowing disorders;
- History of food allergy with hypersensitivity to any of the components of olive oil and/or oleaginous;
Show all 14Show fewer
- Eating habits in the last two months that characterize the diet of the Mediterranean;
- Significant alterations in appetite in the last three months or change of weight over 5 kg in the last three months;
- Illegal use of drugs or chronic alcoholism, clinically significant depression or ongoing psychiatric care;
- Inability to communicate;
- Severe chronic diseases;
- Self-reported terminal disease;
- Plan to move city in two months;
- Participation in another clinical trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Mediterranean-type Diet for Older Adults With Obstructive Sleep Apnea: Randomized Clinical Trial - MedOOSA Project
The majority of the elderly present with sleep apnea and mortality is significantly higher in this group. Sleep apnea runs the risk of developing diseases, especially hypertension and cardiovascular disease, while the Mediterranean diet is associated with reduced risk.
No study evaluated the effect of the Mediterranean diet on the apnea and hypopnea index in the elderly. Therefore, the present work intends to evaluate the effect of the intervention with the Mediterranean diet on the apnea-hypopnea index in the elderly with moderate sleep apnea.
The hypothesis study is that the elderly with moderately severe sleep apnea under a Mediterranean-type diet will modify AHI in the short term, regardless of weight change, due to changes in body volume and ingestion, especially those related to body water.
Read the detailed description
PRIMARY OBJECTIVE:
To evaluate the effect of the Mediterranean diet intervention on the apnea-hypopnea index in the elderly with moderate-severe sleep apnea.
SECONDARY OBJECTIVES:
- To compare the effect of intervention with Mediterranean diet on the effect of low-fat diet (control) on anthropometric variables (BMI, neck and waist circumferences) and bioimpedance (body water, lean mass, fat mass).
- To compare the effect of the intervention with a diet of the Mediterranean type to the effect of the intervention with a low-fat diet (control) on glycolipid profile, C-reactive protein, Sodium, and Potassium.
- To compare the effect of the Mediterranean diet intervention on the effect of the low-fat diet (control) on blood pressure: systolic, diastolic and heart rate measured in 24-hour ABPM.
PROCEDURES:
All variables will be measured equally in the two groups: Mediterranean diet and control diet. The provision of extra virgin olive oil and oilseeds will be provided free to participants randomized to the Mediterranean diet at visits 1 and 2 and participants randomized to the control diet will receive nutritional guidelines. There will be no caloric restriction for both groups, nor will there be any increase in physical activity.
All participants will be interviewed by a nutritionist and a nutritionist at the baseline and at all subsequent visits, and the dietary guidelines will be given by the same nutritionist. Evaluations with participants from both groups will be organized separately for each of the groups. All participants will be instructed not to use multivitamins or antioxidant supplements during the study period.
ASSESSMENT OF ADHERENCE TO THE MEDITERRANEAN DIET:
A questionnaire with 14 items (Annex 3) assessing adherence to the Mediterranean diet will be used. A value of 0 (not compatible) or 1 (compatible) will be assigned to each item answered on the diet. Higher scores will reflect better adherence to the diet. High adherence will be set when matching at least 11 of the 14 items.
RANDOMIZATION:
The randomization to the diet group of the Mediterranean type or Diet Control will be performed by withdrawing the envelope in groups of 4 following random numbers generated by computer.
SAMPLE SIZE The sample size calculation is based on the study "Effect of Mediterranean diet versus prudent diet combined with physical activity on OSAS: a randomized trial" 45. For a 5% alpha error and 80% power, the calculated sample size was 24 patients in each group to detect an effect size of 0.25 standard deviation. However, considering withdrawals, withdrawal of consent, absenteeism, and case losses during the study period, up to 25 patients will be evaluated in the Mediterranean diet group and 25 in the control diet group.
STATISTICAL ANALYSIS The demographic characteristics and other variables of interest of the participants of the Mediterranean diet and Diet control groups will be compared using the Student's t-test or the chi-square test. Paired t-test or non-parametric test will be performed to compare measures at baseline and after two months of intervention within each group. Differences of measures of interest will be determined between the groups using covariance analysis (ANCOVA) controlled by the corresponding baseline levels, sex, and age or by non-parametric test. The transformation to log for data that is not normally distributed will be used. The significance of P <0.05 will be considered significant. The analyzes will be performed with the IBM SPSS Statistics version 20 program.
- Conditions
- Sleep Apnea
- Being tested
- Mediterranean-type diet, Low fat diet
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean-type dietOther
Recommendations: ingest whole grains; three or more servings/day (various fresh fruits/vegetables); three or more servings/week of fish or seafood; white meat to red and processed meat (red meat to one serving or less/day); oilseed mix - 30g/day (nuts: 15g/day, almonds: 7.5g/day, hazelnuts: 7.5g/day); extra virgin olive oil (30ml/day: 2 soup spoons/day) as the main source of fat in the salads; two or more servings per week of "sofrito"; two servings/day of low-fat dairy products; limit to one serving/week the intake of fatty and cured cheeses; recommendation of 7 glasses per week of red wine (recommendation for habitual drinkers): 1 cup/day of 100ml for women and 1-2 cups/day of 150ml for men; limit to one serving/week the intake of chocolate with more than 50% cocoa.
Low fat dietOther
Recommendations: choose grilled, cooked, baked or soaked preparations; avoid frying (sweet or salty); avoid excess fat in the preparations and season the foods with herbs at will (marjoram, basil, oregano, onion, green seasoning, sweet pepper, sage, etc.); avoid frequent ingestion of sausages such as ham, turkey breast, among others; avoid eating fatty meats and strip the skin of poultry before preparation; avoid eating sweets and fatty foods; avoid ingesting bakery products, such as leafy, tart, savory pasta.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean-type diet | Experimental | Recommends high consumption of whole grains, vegetables, nuts, fruits, vegetables and olive oil as the main source of fat used for salads. Moderate to high fish consumption and low consumption of red and processed meats. Poultry and dairy products (such as yogurt or cheese) will be consumed in small quantities and moderate consumption of alcohol, usually in the form of red wine, will be recommended with meals for usual drinkers. Receives: Other: Mediterranean-type diet |
| Low fat diet | Active comparator | It recommends reducing the intake of foods rich in fats, especially those saturated and hydrogenated. Receives: Other: Low fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index
Evaluated with portable polygraphy.
Measured: 12 weeks
Secondary outcomes (7)
Body weight
Clinical scale will be used with 100g precision.
Measured: 12 weeks
Body composition
Measured by bio-impedance. The device used will be Biodynamics®, model 450, version 5.1 International.
Measured: 12 weeks
glucose
Blood collection will be performed between 07:30 and 9:30 a.m. in the morning of 12 hours, by a trained technician who will obtain a blood sample by venipuncture.
Measured: 12 weeks
Cholesterol total
Blood collection will be performed between 07:30 and 9:30 a.m. in the morning of 12 hours, by a trained technician who will obtain a blood sample by venipuncture.
Measured: 12 weeks
LDL-Cholesterol
Blood collection will be performed between 07:30 and 9:30 a.m. in the morning of 12 hours, by a trained technician who will obtain a blood sample by venipuncture.
Measured: 12 weeks
HDL-cholesterol
Blood collection will be performed between 07:30 and 9:30 a.m. in the morning of 12 hours, by a trained technician who will obtain a blood sample by venipuncture.
Measured: 12 weeks
Triglycerides
Blood collection will be performed between 07:30 and 9:30 a.m. in the morning of 12 hours, by a trained technician who will obtain a blood sample by venipuncture.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start1 May 2018 (estimated)
- Primary completion31 Mar 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Model description
- A randomized clinical trial will be conducted and the sample will consist of 50 participants who performed portable respiratory polysomnography. Cases with AHI between 15 and 50 events per hour will be sent for medical evaluation to identify inclusion/exclusion criteria. Eligible individuals who agree to participate in the study, after signing the Informed Consent Term, will perform physical, biochemical, questionnaire and randomized to receive guidelines on the Mediterranean-type diet or low-fat diet.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Martinez, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514199
- Sponsor's protocol ID
- 79655917700005327
- Acronym
- MedOOSA
- Status last verified
- Feb 2018
- First submitted
- 20 Apr 2018
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean-type Diet for Older Adults With Obstructive Sleep Apnea: Randomized Clinical Trial - MedOOSA Project
- ClinicalTrials.gov ID
- NCT03514199
- Acronym / sponsor ID
- MedOOSA / 79655917700005327
- Conditions
- Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 2 May 2018 (actual)
- 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 majority of the elderly present with sleep apnea and mortality is significantly higher in this group. Sleep apnea runs the risk of developing diseases, especially hypertension and cardiovascular disease, while the Mediterranean diet is associated with reduced risk.
No study evaluated the effect of the Mediterranean diet on the apnea and hypopnea index in the elderly. Therefore, the present work intends to evaluate the effect of the intervention with the Mediterranean diet on the apnea-hypopnea index in the elderly with moderate sleep apnea.
The hypothesis study is that the elderly with moderately severe sleep apnea under a Mediterranean-type diet will modify AHI in the short term, regardless of weight change, due to changes in body volume and ingestion, especially those related to body water.
Detailed description
PRIMARY OBJECTIVE:
To evaluate the effect of the Mediterranean diet intervention on the apnea-hypopnea index in the elderly with moderate-severe sleep apnea.
SECONDARY OBJECTIVES:
- To compare the effect of intervention with Mediterranean diet on the effect of low-fat diet (control) on anthropometric variables (BMI, neck and waist circumferences) and bioimpedance (body water, lean mass, fat mass).
- To compare the effect of the intervention with a diet of the Mediterranean type to the effect of the intervention with a low-fat diet (control) on glycolipid profile, C-reactive protein, Sodium, and Potassium.
- To compare the effect of the Mediterranean diet intervention on the effect of the low-fat diet (control) on blood pressure: systolic, diastolic and heart rate measured in 24-hour ABPM.
PROCEDURES:
All variables will be measured equally in the two groups: Mediterranean diet and control diet. The provision of extra virgin olive oil and oilseeds will be provided free to participants randomized to the Mediterranean diet at visits 1 and 2 and participants randomized to the control diet will receive nutritional guidelines. There will be no caloric restriction for both groups, nor will there be any increase in physical activity.
All participants will be interviewed by a nutritionist and a nutritionist at the baseline and at all subsequent visits, and the dietary guidelines will be given by the same nutritionist. Evaluations with participants from both groups will be organized separately for each of the groups. All participants will be instructed not to use multivitamins or antioxidant supplements during the study period.
ASSESSMENT OF ADHERENCE TO THE MEDITERRANEAN DIET:
A questionnaire with 14 items (Annex 3) assessing adherence to the Mediterranean diet will be used. A value of 0 (not compatible) or 1 (compatible) will be assigned to each item answered on the diet. Higher scores will reflect better adherence to the diet. High adherence will be set when matching at least 11 of the 14 items.
RANDOMIZATION:
The randomization to the diet group of the Mediterranean type or Diet Control will be performed by withdrawing the envelope in groups of 4 following random numbers generated by computer.
SAMPLE SIZE The sample size calculation is based on the study "Effect of Mediterranean diet versus prudent diet combined with physical activity on OSAS: a randomized trial" 45. For a 5% alpha error and 80% power, the calculated sample size was 24 patients in each group to detect an effect size of 0.25 standard deviation. However, considering withdrawals, withdrawal of consent, absenteeism, and case losses during the study period, up to 25 patients will be evaluated in the Mediterranean diet group and 25 in the control diet group.
STATISTICAL ANALYSIS The demographic characteristics and other variables of interest of the participants of the Mediterranean diet and Diet control groups will be compared using the Student's t-test or the chi-square test. Paired t-test or non-parametric test will be performed to compare measures at baseline and after two months of intervention within each group. Differences of measures of interest will be determined between the groups using covariance analysis (ANCOVA) controlled by the corresponding baseline levels, sex, and age or by non-parametric test. The transformation to log for data that is not normally distributed will be used. The significance of P <0.05 will be considered significant. The analyzes will be performed with the IBM SPSS Statistics version 20 program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized clinical trial will be conducted and the sample will consist of 50 participants who performed portable respiratory polysomnography. Cases with AHI between 15 and 50 events per hour will be sent for medical evaluation to identify inclusion/exclusion criteria. Eligible individuals who agree to participate in the study, after signing the Informed Consent Term, will perform physical, biochemical, questionnaire and randomized to receive guidelines on the Mediterranean-type diet or low-fat diet.
| Arm | Type | Receives |
|---|---|---|
| Mediterranean-type diet | Experimental | Other: Mediterranean-type dietRecommends high consumption of whole grains, vegetables, nuts, fruits, vegetables and olive oil as the main source of fat used for salads. Moderate to high fish consumption and low consumption of red and processed meats. Poultry and dairy products (such as yogurt or cheese) will be consumed in small quantities and moderate consumption of alcohol, usually in the form of red wine, will be recommended with meals for usual drinkers. |
| Low fat diet | Active comparator | Other: Low fat dietIt recommends reducing the intake of foods rich in fats, especially those saturated and hydrogenated. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Agreement to sign the ICF;
- AHI between 15 and 50 events/h;
- Age between 65 and 80 years;
- Both sexes;
- BMI between 27-39.9 kg / m2.
Key exclusion criteria (14 listed)
- In treatment for sleep apnea;
- Predominantly central sleep apnea;
- Feed predominantly of meals provided by third parties;
- Gastrointestinal disease, with intolerance to fat intake;
- Impossibility to follow the Mediterranean diet due to the presence of mastication and/or swallowing disorders;
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 |
|---|---|---|
| Mediterranean-type dietRecommendations: ingest whole grains; three or more servings/day (various fresh fruits/vegetables); three or more servings/week of fish or seafood; white meat to red and processed meat (red meat to one serving or less/day); oilseed mix - 30g/day (nuts: 15g/day, almonds: 7.5g/day, hazelnuts: 7.5g/day); extra virgin olive oil (30ml/day: 2 soup spoons/day) as the main source of fat in the salads; two or more servings per week of "sofrito"; two servings/day of low-fat dairy products; limit to one serving/week the intake of fatty and cured cheeses; recommendation of 7 glasses per week of red wine (recommendation for habitual drinkers): 1 cup/day of 100ml for women and 1-2 cups/day of 150ml for men; limit to one serving/week the intake of chocolate with more than 50% cocoa. | Other | Mediterranean-type diet |
| Low fat dietRecommendations: choose grilled, cooked, baked or soaked preparations; avoid frying (sweet or salty); avoid excess fat in the preparations and season the foods with herbs at will (marjoram, basil, oregano, onion, green seasoning, sweet pepper, sage, etc.); avoid frequent ingestion of sausages such as ham, turkey breast, among others; avoid eating fatty meats and strip the skin of poultry before preparation; avoid eating sweets and fatty foods; avoid ingesting bakery products, such as leafy, tart, savory pasta. | Other | Low fat diet |
Primary outcome
Apnea-hypopnea index
Time frame: 12 weeks
Evaluated with portable polygraphy.
7 secondary outcomes
Body weight
Time frame: 12 weeks
Body composition
Time frame: 12 weeks
glucose
Time frame: 12 weeks
Cholesterol total
Time frame: 12 weeks
LDL-Cholesterol
Time frame: 12 weeks
HDL-cholesterol
Time frame: 12 weeks
Triglycerides
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Denis Martinez, PhD principal investigator
Hospital de Clinicas de Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean-type diet and Low fat diet in people with Sleep Apnea, run by Hospital de Clinicas de Porto Alegre.
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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renata Kaminski, M.D. (+5551981216376, denis@sono.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypopnea index (time frame: 12 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 2 May 2018.