Obstructive Sleep ApneaNCT06782737
Mediterranean Diet Versus Standard Diet on Candiormetabolic Indicator in Patients With Apnea
A study testing Dietetic interventión with mediterranean diet in people with Obstructive Sleep Apnea, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
Introduction. Worldwide, obstructive sleep apnea is estimated to affect one in seven individuals. Patients with OSA present chronic low-grade inflammation related to arteriosclerosis. The effect of the Mediterranean diet on metabolic risk indicators is still inconclusive in the OSA population. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Dietetic interventión with mediterranean diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteMexico
- Study dates
- 15 Oct 2024to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women
- Clinical diagnosis of sleep apnea
- Diagnosis of moderate and severe OSA
Who cannot join
- Anatomical alterations of the nose, oropharynx or maxilla.
- Chronic kidney disease in substantive treatment of renal function
- Decompensated heart failure
- Cancer
- Depression
- Anxiety
Show all 11Show fewer
- Neurological disease.
- Treatment with benzodiazepines, antidepressants, anxiolytics and hypnotics.
- Refractory Dyslipidemia
- Familial Dyslipidemia
- Surgeries in less than 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Instituto Mexicano Del Seguro Social
Mexico City, Mexico City, 03100
About this study
Official title: Effect of the Mediterranean Type Diet Versus Standard Diet on Cardiometabolic Indicator in Patients With Obstructive Sleep Apnea
Introduction. Worldwide, obstructive sleep apnea is estimated to affect one in seven individuals. Patients with OSA present chronic low-grade inflammation related to arteriosclerosis. The effect of the Mediterranean diet on metabolic risk indicators is still inconclusive in the OSA population.
Objective: To evaluate the effect of a Mediterranean diet adapted to the Mexican diet, versus standard nutritional treatment, on metabolic risk indicators in patients with obstructive sleep apnea.
Material and methods: Randomized clinical trial in patients with OSA confirmed by polysomnography. Sociodemographic data, pathological and non-pathological history, as well as clinical data will be collected by interview. Patients will be randomly assigned to the group with personalized Mediterranean-type diet adapted to the Mexican diet or standard diet for patients with OSA. At baseline, 6 and 12 months with the patient fasting, glucose levels and lipid profile in venous blood will be measured, as well as carotid artery thickness. Anthropometry and body composition measurements will also be taken, in addition to questionnaires to measure sleep quality, physical exercise and quality of life, as well as to measure dietary adherence with 3-day food records. A descriptive analysis of qualitative variables will be performed with frequencies and percentages; quantitative variables will be presented according to their free or parametric distribution. An X2 will be performed to compare the difference between the proportions of the outcome variables, as well as a Student's t-test or Mann Whitney U test according to their parametric or free distribution. A multivariate analysis will be performed to see the effect of both interventions on the main outcome variables, obesity, dyslipidemia and glycemic control.
Read the detailed description
Once the inclusion criteria have been confirmed, a detailed explanation of the study will be given, and the responsible investigators will clarify any doubts about the study. The patient will freely agree to participate in the research by signing the informed consent letter.
The following measurements will be taken in all patients:
Sociodemographic and clinical data. A medical interrogation will be made by the research team to collect sociodemographic data, pathological and non-pathological clinical history. The patient will be questioned about his or her age, clinical history with pathological and non-pathological personal history, pharmacological and non-pharmacological treatment.
Blood Pressure Measurement Blood pressure will be measured by the medical team participating in the study, with a calibrated sphygmomanometer, without previous coffee consumption, without having smoked or consumed cola in the last 30 minutes. The patient will be seated in a chair, with his back supported, without crossing his feet.
. Measurement of sleep variables. In the first time consultation of the Sleep Clinic, parameters of AHI and ODI will be taken with the CPAP equipment, which is part of the studies that are routinely performed in patients with obstructive sleep apnea. It lasts 7 to 8 hours.
Polysomnography: We will proceed to the assembly of the channels that make up the polysomnography: electroencephalographic and electro-oculogram derivations, electromyogram of chin and legs, respiratory flow signals thermistor and/or nasal cannula, respiratory effort signals, continuous oxygen monitoring, electrocardiogram, and determination of the patient's body position.
Measurement of biochemical indicators. With the patient fasting for 8 to 10 hours, a blood sample will be taken in venous blood to measure glucose, lipid profile (Cholesterol, Triglycerides, LDH, VLDL). Measurements to be taken at the first consultation, 6 and 12 months.
Anthropometric and body composition measurements The measurement of the anthropometric data will be done by the nutritionists participating in this research, previously standardized.for the measurement of the body composition the InBody equipment will be used, where the percentage of fat, fat mass, lean mass, total liquids will be obtained.
The Epworth Sleepiness Scale, sleep diary, as well as measures and applied sleep changes will be used. The Epworth Sleepiness Scale (ESE) assesses 8 items, each with a 0 to 3 point response, where 0 means no likelihood of nodding off or falling asleep, 1 means slight likelihood of nodding off or falling asleep, 2 moderate likelihood of nodding off or falling asleep, and 3 high likelihood of falling asleep. If the patient scores 1 to 6 it is considered normal sleep, 7 to 8 points average sleepiness, and 9 to 24 points pathological (abnormal) sleepiness.
Apnea-hypopnea index.
This will be obtained through CPAP readings where the level of severity of OSA before and after the intervention will be calculated. It will be classified:
- Mild: apnea-hypopnea index ≥ 5 and < 15 per hour.
- Moderate: apnea-hypopnea index ≥ 15 and ≤ 30 per hour.
- Severe: apnea-hypopnea index > 30 per hour. Measurement of quality of life It will be obtained from the QSQ questionnaire (Quebec Sleep Questionnaire) which has been validated in Hispanic population.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Dietetic interventión with mediterranean diet
- Keywords
- obstructive sleep apnea, obesity, cardiometabolic risk, mediterranean diet, nutritional therapy
- 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.
Dietetic interventión with mediterranean dietOther
Also called Mediterranean diet
Personalized dietary Mediterranean diet
| Study group | Role | What they receive |
|---|---|---|
| Intervention Mediterranean diet | Experimental | Patients in this group will be given a normocaloric diet with the following energy distribution (Protein: 15-20%, Carbohydrate: 50-55%, Fat: 25-30%, Saturated fat: <7%) according to the guidelines for adult patients with OSA. The Mifflin-St. Mifflin equation will be applied to determine the energy needs of each patient. They will receive individual nutritional counseling at the beginning of the study on hygienic sleep measures and Mediterranean-type diet adjusted to foods in Mexico. Pre-established menus will be calculated with foods that are characteristic of the Mediterranean-type diet, containing fruits, vegetables, whole grains, cereals, white meat content.
Sample menus: Weekly menus will be designed to guide the indicated meal plan of the patients. The menus to be designed will be of 1200, 1400, 1600, 1800, 1800, 2000 and 2200 calories. Specifications will be given for the promotion of foods with higher complex carbohydrate content, white meats, fruits and vegetables. Receives: Other: Dietetic interventión with mediterranean diet |
| Control | No intervention | Patients in this group will be given a normocaloric diet with the following energy distribution (Protein: 15-20%, Carbohydrate: 50-55%, Fat: 25-30%, Saturated fat: <7%) according to the guidelines for adult patients with OSA. The Mifflin-St. Mifflin equation will be applied to determine the energy needs of each patient. To achieve energy needs and distribution, a specific meal plan containing common foods divided into food equivalent groups will be administered to patients. Nutritional counseling will be considered on an individual basis on hygienic sleep measures and type of diet for weight loss according to age, sex, current body weight and present comorbidity. At the beginning of the intervention, a 24-hour food reminder will be made to know their usual diet. They will be given a triptych for adherence to the indicated diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose
blood glucose level at baseline and at the end of the study
Measured: 12 months
tryglicerides
Blood triglyceride level at baseline and end of study
Measured: 12 months
body mass index
body mass index
Measured: 12 months
Secondary outcomes (2)
Measurement of sleep quality
Measurement of sleep quality The Epworth Sleepiness Scale, sleep diary, as well as measures and applied sleep changes will be used. The Epworth Sleepiness Scale (ESE) assesses 8 items, each with a 0 to 3 point response, where 0 means no likelihood of nodding off or falling asleep, 1 means slight likelihood of nodding off or falling asleep, 2 moderate likelihood of nodding off or falling asleep, and 3 means high probability of falling asleep. If the patient obtains a score of 1 to 6 is considered normal sleep, 7 to 8 points average sleepiness, and 9 to 24 points pathological sleepiness (anaesthesia).
pathological (abnormal) sleepiness. Apnea-hypopnea index.
Measured: The baseline and 12 months after the intervention will be evaluated.
Measurement of quality of life
It will be obtained from the QSQ questionnaire (Quebec Sleep Questionnaire) which has been validated in the Hispanic population.
in the Hispanic population. It consists of 32 items focused on measuring daily sleepiness: items 7, 16, 20, 27, 31, 32,
Daytime symptoms: 1, 10, 11, 14, 17, 17, 18, 19, 23, 26, 29. Nighttime symptoms:
4, 9, 21, 22, 25, 28, 30. Emotions: 5, 6, 8, 15, 24. Social interactions: 2, 3, 12, 13.
This questionnaire will be applied at baseline and 12 months follow-up.
Measured: The baseline and 12 months after the intervention will be evaluated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start15 Oct 2024
- Primary completion13 Dec 2024
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lubia Velázquez López, Coordinación de Investigación en Salud, Mexico
- Investigators
- Lubia Velazquez, PhD, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782737
- Sponsor's protocol ID
- R-2024-3609-055
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carneiro-Barrera A, Amaro-Gahete FJ, Guillen-Riquelme A, Jurado-Fasoli L, Saez-Roca G, Martin-Carrasco C, Buela-Casal G, Ruiz JR. Effect of an Interdisciplinary Weight Loss and Lifestyle Intervention on Obstructive Sleep Apnea Severity: The INTERAPNEA Randomized Clinical Trial. JAMA Netw Open. 2022 Apr 1;5(4):e228212. doi: 10.1001/jamanetworkopen.2022.8212.
PubMed 35452108Martinez-Gonzalez MA, Salas-Salvado J, Estruch R, Corella D, Fito M, Ros E; PREDIMED INVESTIGATORS. Benefits of the Mediterranean Diet: Insights From the PREDIMED Study. Prog Cardiovasc Dis. 2015 Jul-Aug;58(1):50-60. doi: 10.1016/j.pcad.2015.04.003. Epub 2015 May 1.
PubMed 25940230Godos J, Ferri R, Lanza G, Caraci F, Vistorte AOR, Yelamos Torres V, Grosso G, Castellano S. Mediterranean Diet and Sleep Features: A Systematic Review of Current Evidence. Nutrients. 2024 Jan 17;16(2):282. doi: 10.3390/nu16020282.
PubMed 38257175Liu Y, Wheaton AG, Chapman DP, Cunningham TJ, Lu H, Croft JB. Prevalence of Healthy Sleep Duration among Adults--United States, 2014. MMWR Morb Mortal Wkly Rep. 2016 Feb 19;65(6):137-41. doi: 10.15585/mmwr.mm6506a1.
PubMed 26890214Powell TA, Mysliwiec V, Brock MS, Morris MJ. OSA and cardiorespiratory fitness: a review. J Clin Sleep Med. 2022 Jan 1;18(1):279-288. doi: 10.5664/jcsm.9628.
PubMed 34437054Gaines J, Vgontzas AN, Fernandez-Mendoza J, Bixler EO. Obstructive sleep apnea and the metabolic syndrome: The road to clinically-meaningful phenotyping, improved prognosis, and personalized treatment. Sleep Med Rev. 2018 Dec;42:211-219. doi: 10.1016/j.smrv.2018.08.009. Epub 2018 Sep 3.
PubMed 30279095Valenza MC, Martin Martin L, Gonzalez Jimenez E, Aguilar Cordero MJ, Botella Lopez M, Munoz Casaubon T, Valenza Demet G. [Risk factors for metabolic syndrome in a population with sleep apnea; evaluation in a population of Granada; the Granada study]. Nutr Hosp. 2012 Jul-Aug;27(4):1255-60. doi: 10.3305/nh.2012.27.4.5825. Spanish.
PubMed 23165570Salman LA, Shulman R, Cohen JB. Obstructive Sleep Apnea, Hypertension, and Cardiovascular Risk: Epidemiology, Pathophysiology, and Management. Curr Cardiol Rep. 2020 Jan 18;22(2):6. doi: 10.1007/s11886-020-1257-y.
PubMed 31955254
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Mediterranean Type Diet Versus Standard Diet on Cardiometabolic Indicator in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06782737
- Acronym / sponsor ID
- R-2024-3609-055
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, obesity, cardiometabolic risk, mediterranean diet, nutritional therapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 20 Jan 2025 (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.
Introduction. Worldwide, obstructive sleep apnea is estimated to affect one in seven individuals. Patients with OSA present chronic low-grade inflammation related to arteriosclerosis. The effect of the Mediterranean diet on metabolic risk indicators is still inconclusive in the OSA population.
Objective: To evaluate the effect of a Mediterranean diet adapted to the Mexican diet, versus standard nutritional treatment, on metabolic risk indicators in patients with obstructive sleep apnea.
Material and methods: Randomized clinical trial in patients with OSA confirmed by polysomnography. Sociodemographic data, pathological and non-pathological history, as well as clinical data will be collected by interview. Patients will be randomly assigned to the group with personalized Mediterranean-type diet adapted to the Mexican diet or standard diet for patients with OSA. At baseline, 6 and 12 months with the patient fasting, glucose levels and lipid profile in venous blood will be measured, as well as carotid artery thickness. Anthropometry and body composition measurements will also be taken, in addition to questionnaires to measure sleep quality, physical exercise and quality of life, as well as to measure dietary adherence with 3-day food records. A descriptive analysis of qualitative variables will be performed with frequencies and percentages; quantitative variables will be presented according to their free or parametric distribution. An X2 will be performed to compare the difference between the proportions of the outcome variables, as well as a Student's t-test or Mann Whitney U test according to their parametric or free distribution. A multivariate analysis will be performed to see the effect of both interventions on the main outcome variables, obesity, dyslipidemia and glycemic control.
Detailed description
Once the inclusion criteria have been confirmed, a detailed explanation of the study will be given, and the responsible investigators will clarify any doubts about the study. The patient will freely agree to participate in the research by signing the informed consent letter.
The following measurements will be taken in all patients:
Sociodemographic and clinical data. A medical interrogation will be made by the research team to collect sociodemographic data, pathological and non-pathological clinical history. The patient will be questioned about his or her age, clinical history with pathological and non-pathological personal history, pharmacological and non-pharmacological treatment.
Blood Pressure Measurement Blood pressure will be measured by the medical team participating in the study, with a calibrated sphygmomanometer, without previous coffee consumption, without having smoked or consumed cola in the last 30 minutes. The patient will be seated in a chair, with his back supported, without crossing his feet.
. Measurement of sleep variables. In the first time consultation of the Sleep Clinic, parameters of AHI and ODI will be taken with the CPAP equipment, which is part of the studies that are routinely performed in patients with obstructive sleep apnea. It lasts 7 to 8 hours.
Polysomnography: We will proceed to the assembly of the channels that make up the polysomnography: electroencephalographic and electro-oculogram derivations, electromyogram of chin and legs, respiratory flow signals thermistor and/or nasal cannula, respiratory effort signals, continuous oxygen monitoring, electrocardiogram, and determination of the patient's body position.
Measurement of biochemical indicators. With the patient fasting for 8 to 10 hours, a blood sample will be taken in venous blood to measure glucose, lipid profile (Cholesterol, Triglycerides, LDH, VLDL). Measurements to be taken at the first consultation, 6 and 12 months.
Anthropometric and body composition measurements The measurement of the anthropometric data will be done by the nutritionists participating in this research, previously standardized.for the measurement of the body composition the InBody equipment will be used, where the percentage of fat, fat mass, lean mass, total liquids will be obtained.
The Epworth Sleepiness Scale, sleep diary, as well as measures and applied sleep changes will be used. The Epworth Sleepiness Scale (ESE) assesses 8 items, each with a 0 to 3 point response, where 0 means no likelihood of nodding off or falling asleep, 1 means slight likelihood of nodding off or falling asleep, 2 moderate likelihood of nodding off or falling asleep, and 3 high likelihood of falling asleep. If the patient scores 1 to 6 it is considered normal sleep, 7 to 8 points average sleepiness, and 9 to 24 points pathological (abnormal) sleepiness.
Apnea-hypopnea index.
This will be obtained through CPAP readings where the level of severity of OSA before and after the intervention will be calculated. It will be classified:
- Mild: apnea-hypopnea index ≥ 5 and < 15 per hour.
- Moderate: apnea-hypopnea index ≥ 15 and ≤ 30 per hour.
- Severe: apnea-hypopnea index > 30 per hour. Measurement of quality of life It will be obtained from the QSQ questionnaire (Quebec Sleep Questionnaire) which has been validated in Hispanic population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Mediterranean diet | Experimental | Other: Dietetic interventión with mediterranean dietPatients in this group will be given a normocaloric diet with the following energy distribution (Protein: 15-20%, Carbohydrate: 50-55%, Fat: 25-30%, Saturated fat: <7%) according to the guidelines for adult patients with OSA. The Mifflin-St. Mifflin equation will be applied to determine the energy needs of each patient. They will receive individual nutritional counseling at the beginning of the study on hygienic sleep measures and Mediterranean-type diet adjusted to foods in Mexico. Pre-established menus will be calculated with foods that are characteristic of the Mediterranean-type diet, containing fruits, vegetables, whole grains, cereals, white meat content. Sample menus: Weekly menus will be designed to guide the indicated meal plan of the patients. The menus to be designed will be of 1200, 1400, 1600, 1800, 1800, 2000 and 2200 calories. Specifications will be given for the promotion of foods with higher complex carbohydrate content, white meats, fruits and vegetables. |
| Control | No intervention | –Patients in this group will be given a normocaloric diet with the following energy distribution (Protein: 15-20%, Carbohydrate: 50-55%, Fat: 25-30%, Saturated fat: <7%) according to the guidelines for adult patients with OSA. The Mifflin-St. Mifflin equation will be applied to determine the energy needs of each patient. To achieve energy needs and distribution, a specific meal plan containing common foods divided into food equivalent groups will be administered to patients. Nutritional counseling will be considered on an individual basis on hygienic sleep measures and type of diet for weight loss according to age, sex, current body weight and present comorbidity. At the beginning of the intervention, a 24-hour food reminder will be made to know their usual diet. They will be given a triptych for adherence to the indicated diet. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women
- Clinical diagnosis of sleep apnea
- Diagnosis of moderate and severe OSA
Key exclusion criteria (11 listed)
- Anatomical alterations of the nose, oropharynx or maxilla.
- Chronic kidney disease in substantive treatment of renal function
- Decompensated heart failure
- Cancer
- Depression
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 |
|---|---|---|
| Dietetic interventión with mediterranean dietAlso: Mediterranean dietPersonalized dietary Mediterranean diet | Other | Intervention Mediterranean diet |
Primary outcome
glucose
Time frame: 12 months
blood glucose level at baseline and at the end of the study
tryglicerides
Time frame: 12 months
Blood triglyceride level at baseline and end of study
body mass index
Time frame: 12 months
body mass index
2 secondary outcomes
Measurement of sleep quality
Time frame: The baseline and 12 months after the intervention will be evaluated.
Measurement of quality of life
Time frame: The baseline and 12 months after the intervention will be evaluated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Background: PubMed 35452108Carneiro-Barrera A, Amaro-Gahete FJ, Guillen-Riquelme A, Jurado-Fasoli L, Saez-Roca G, Martin-Carrasco C, Buela-Casal G, Ruiz JR. Effect of an Interdisciplinary Weight Loss and Lifestyle Intervention on Obstructive Sleep Apnea Severity: The INTERAPNEA Randomized Clinical Trial. JAMA Netw Open. 2022 Apr 1;5(4):e228212. doi: 10.1001/jamanetworkopen.2022.8212.
- Background: PubMed 25940230Martinez-Gonzalez MA, Salas-Salvado J, Estruch R, Corella D, Fito M, Ros E; PREDIMED INVESTIGATORS. Benefits of the Mediterranean Diet: Insights From the PREDIMED Study. Prog Cardiovasc Dis. 2015 Jul-Aug;58(1):50-60. doi: 10.1016/j.pcad.2015.04.003. Epub 2015 May 1.
- Background: PubMed 38257175Godos J, Ferri R, Lanza G, Caraci F, Vistorte AOR, Yelamos Torres V, Grosso G, Castellano S. Mediterranean Diet and Sleep Features: A Systematic Review of Current Evidence. Nutrients. 2024 Jan 17;16(2):282. doi: 10.3390/nu16020282.
- Results publication: PubMed 26890214Liu Y, Wheaton AG, Chapman DP, Cunningham TJ, Lu H, Croft JB. Prevalence of Healthy Sleep Duration among Adults--United States, 2014. MMWR Morb Mortal Wkly Rep. 2016 Feb 19;65(6):137-41. doi: 10.15585/mmwr.mm6506a1.
- Results publication: PubMed 34437054Powell TA, Mysliwiec V, Brock MS, Morris MJ. OSA and cardiorespiratory fitness: a review. J Clin Sleep Med. 2022 Jan 1;18(1):279-288. doi: 10.5664/jcsm.9628.
- Results publication: PubMed 30279095Gaines J, Vgontzas AN, Fernandez-Mendoza J, Bixler EO. Obstructive sleep apnea and the metabolic syndrome: The road to clinically-meaningful phenotyping, improved prognosis, and personalized treatment. Sleep Med Rev. 2018 Dec;42:211-219. doi: 10.1016/j.smrv.2018.08.009. Epub 2018 Sep 3.
- Results publication: PubMed 23165570Valenza MC, Martin Martin L, Gonzalez Jimenez E, Aguilar Cordero MJ, Botella Lopez M, Munoz Casaubon T, Valenza Demet G. [Risk factors for metabolic syndrome in a population with sleep apnea; evaluation in a population of Granada; the Granada study]. Nutr Hosp. 2012 Jul-Aug;27(4):1255-60. doi: 10.3305/nh.2012.27.4.5825. Spanish.
- Results publication: PubMed 31955254Salman LA, Shulman R, Cohen JB. Obstructive Sleep Apnea, Hypertension, and Cardiovascular Risk: Epidemiology, Pathophysiology, and Management. Curr Cardiol Rep. 2020 Jan 18;22(2):6. doi: 10.1007/s11886-020-1257-y.
- Individual participant dataSharing planned: No
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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.
Lubia Velazquez, PhD principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietetic interventión with mediterranean diet in people with Obstructive Sleep Apnea, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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 11 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: enrolling by invitation, as of the sponsor's last update on 20 Jan 2025. 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 Mexico. 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?
This study is still under way. Results are not available in the source record yet.
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?
glucose (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT06782737, which also lists 8 linked publications.
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 20 Jan 2025.