Mediterranean-type Diet for Older Adults With Obstructive Sleep Apnea

NCT03514199 | Unknown DMC

• 1 other identifier: 79655917700005327
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea index

  Evaluated with portable polygraphy.

  12 weeks

Secondary Outcomes (7)

• Body weight

  12 weeks

• Body composition

  12 weeks

• glucose

  12 weeks

• Cholesterol total

  12 weeks

• LDL-Cholesterol

  12 weeks

Study Arms (2)

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.

Other: Mediterranean-type diet

Low fat diet

ACTIVE COMPARATOR

It recommends reducing the intake of foods rich in fats, especially those saturated and hydrogenated.

Other: Low fat diet

Interventions

Mediterranean-type diet OTHER

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.

Mediterranean-type diet

Low fat diet OTHER

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.

Low fat diet

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Denis Martinez, PhD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renata Kaminski, M.D.

CONTACT

+5551981216376; denis@sono.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 2, 2018
• Study Start: May 1, 2018
• Primary Completion: March 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 2, 2018

Record last verified: 2018-02