Plant-Based Diet for Sleep Apnea
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Must not be taking: Weight loss medications
Disqualifiers: Pregnancy, Vegan diet, BMI ≤ 22, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This research aims to develop a better understanding and clinical knowledge of the effects of a plant based diet on severity and daytime sleepiness in Obstructive Sleep Apnea.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot be on weight loss medications during the 8-week plant-based diet period.
What data supports the effectiveness of the treatment Whole Food Plant-Based Diet for Sleep Apnea?
A study found that a whole-food plant-based diet reduced daytime sleepiness in patients with obstructive sleep apnea, suggesting it could help manage symptoms.
12345Is a whole-food plant-based diet safe for humans?
Research shows that a whole-food plant-based diet is generally safe for humans and may even reduce the risk of hospitalization due to infections. It has been studied in various conditions like obesity, heart disease, and diabetes, with no significant safety concerns reported.
12367How does the Whole Food Plant-Based Diet treatment for sleep apnea differ from other treatments?
The Whole Food Plant-Based Diet is unique because it focuses on reducing saturated fat intake, which has been linked to decreased daytime sleepiness in sleep apnea patients. Unlike other treatments that may involve devices or medications, this dietary approach offers a natural way to potentially improve symptoms by altering eating habits.
12389Eligibility Criteria
This trial is for individuals who experience excessive daytime sleepiness and have been diagnosed with Obstructive Sleep Apnea. The specific eligibility criteria to participate in the study are not provided, but typically participants would need to meet certain health conditions.Inclusion Criteria
Has access to a weight scale at home or able to come into the Sleep Clinic to be weighed after the 8-week plant-based diet period.
Daytime sleepiness with ESS score ≥ 5
Patient's prior sleep study with AHI between ≥ 10 and ≤ 45 (4% scoring criterion)
+1 more
Exclusion Criteria
Pregnancy or lactation
Current use of a vegan diet
BMI ≤ 22
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants follow either a whole food plant-based diet or continue usual care for 8 weeks
8 weeks
Follow-up
Participants are monitored for changes in daytime sleepiness and sleep apnea severity after treatment
4 weeks
Participant Groups
The study is examining how a Whole Food Plant-Based Diet affects people with Obstructive Sleep Apnea, specifically looking at its impact on the severity of their condition and their levels of daytime sleepiness.
2Treatment groups
Experimental Treatment
Active Control
Group I: Diet Group: Whole Food Plant Based DietExperimental Treatment1 Intervention
Subjects with follow a whole food plant-based diet for 8 weeks.
Group II: Control Group: Usual CareActive Control1 Intervention
Subjects will not change their diet for 8 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic FloridaJacksonville, FL
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
Implementation of a Whole Food Plant Based Diet in a Food as Prevention Program in a Resource Constrained Environment. [2023]The efficacy of a Whole Food Plant-based (WFPB) diet has been shown in randomized controlled trials in diabetes, cardiovascular disease and obesity. However, it's effectiveness in routine clinical settings is less well documented. This study describes the implementation and outcomes of a "Food as Prevention" program run by a single clinician.
Whole-food plant-based diet reduces daytime sleepiness in patients with OSA. [2023]Consumption of a diet high in saturated fat has been associated with daytime sleepiness. A whole-food plant-based (WFPB) dietary pattern, which is low in saturated fat, has been shown to be beneficial in a variety of health conditions. We assessed the effect of a short-term (21 days) WFPB diet intervention on daytime sleepiness in 14 patients with obstructive sleep apnea (OSA). We found a mean decrease of 3.8 points (SD = 3.3, p = 0.003) on the Epworth Sleepiness Scale (ESS) after switching from a standard Western diet to a WFPB diet. Our results suggest that a WFPB diet could be a viable dietary intervention to reduce symptom of daytime sleepiness.
The BROAD study: A randomised controlled trial using a whole food plant-based diet in the community for obesity, ischaemic heart disease or diabetes. [2018]There is little randomised evidence using a whole food plant-based (WFPB) diet as intervention for elevated body mass index (BMI) or dyslipidaemia. We investigated the effectiveness of a community-based dietary programme. Primary end points: BMI and cholesterol at 6 months (subsequently extended).
Effect of Mediterranean diet on lipid peroxidation marker TBARS in obese patients with OSAHS under CPAP treatment: a randomised trial. [2021]The aim of our study was to examine the possible effect of the Mediterranean diet on thiobarbituric acid reacting substances (TBARS) in obese patients with obstructive sleep apnoea/hypopnoea syndrome (OSAHS) who are under continuous positive airway pressure treatment.
A Plant-Based Dietary Intervention for Preoperative Glucose Optimization in Diabetic Patients Undergoing Total Joint Arthroplasty. [2022]Purpose. The purpose of this study was to assess the feasibility and effectiveness of a whole food plant-based diet (WFPBD) to improve day of surgery fasting blood glucose (FBG) among patients with type 2 diabetes (T2D). Patients and Methods. Ten patients with T2D scheduled for a total hip or total knee replacement were recruited. For 3 weeks preceding their surgeries, subjects were asked to consume an entirely WFPBD. Frozen WFPBD meals were professionally prepared and delivered to each participant for the 3 weeks prior to surgery. FBG was reassessed on the morning of surgery and compared with preintervention values. Compliance with the diet was assessed. Results. Mean age of subjects and reported duration of diabetes was 65 and 8 years, respectively, average hemoglobin A1c (HbA1c) was 6.6%, and 6 were women. Mean FBG decreased from 127 to 116 mg/dL (P = .2). Five of the subjects experienced improvement in glycemic control, with an average decline of 11 mg/dL. Conclusion. A WFPBD is a potentially effective intervention to improve glycemic control among patients with T2D during the period leading up to surgery. Future controlled trials on a larger sample of patients to assess the impact of a WFPBD on glycemic control and surgical outcomes are warranted.
Plant-Based Diets and Risk of Hospitalization with Respiratory Infection: Results from the Atherosclerosis Risk in Communities (ARIC) Study. [2023]The benefits of plant-based diets may depend on the type of plant. To determine the associations of healthy and unhealthy plant-based diet types on risk of hospitalization with respiratory infections or any infection, we used dietary intake data reported in a food frequency questionnaire from the Atherosclerosis Risk in Communities Study to calculate a plant-based diet index (PDI), a healthy PDI (HPDI), and an unhealthy PDI (UPDI). Cox regression was used to calculate hazard ratios for the associations of the three plant-based diet indices with the risk of hospitalization with respiratory infections and any infection-related hospitalization. Comparing the highest to lowest quintiles, HPDI was associated with a lower risk of hospitalization with respiratory infections (HR 0.86, 95% CI: 0.75, 0.99), and a lower risk of hospitalization with any infections (HR 0.87, 95% CI: 0.78, 0.97). The PDI was associated with a lower risk of hospitalization with any infections (HR 0.86, 95% CI: 0.76, 0.96). Significant associations were not observed with the UPDI. Adults with a high PDI and HPDI had a lower risk of hospitalization with any infections, whereas adults with a high HPDI had lower risk of hospitalizations with respiratory infections.
Nutrient and Food Intake of Participants in a Whole-Food Plant-Based Lifestyle Program. [2022]We evaluated the nutrient adequacy of a well-planned supplemented whole-food plant-based (WFPB) diet as a component of an ongoing community lifestyle optimization program. We investigated the contributions of nutrients from foods and supplements and plant-based meal replacement (SMR) separately (foods, SMR) and combined (vs recommendations) as well as food group intake, both according to sex.
Association of plant-based diet index with sleep quality in middle-aged and older adults: The Healthy Dance Study. [2023]To investigate the association between plant-based diet indices and sleep quality in Chinese middle-aged and older adults.
Nutritional Status and Dietary Patterns in Adults with Severe Obstructive Sleep Apnea. [2020]Obstructive sleep apnea (OSA) is associated with daytime sleepiness, obesity, and lifestyle and dietary changes. The potential role of diet in OSA has been largely unexplored. The aim of the study was to assess nutritional status and dietary patterns in OSA patients. The study was conducted in 137 adult patients (48 women and 89 men) aged 31-79 suffering from OSA. The following diagnostic procedures were undertaken: polysomnography, anthropometric measurements, and a dietary pattern questionnaire. We found that 128 (93.4%) patients were overweight or obese with the mean body mass index (BMI) of 33.2 ± 6.1 kg/m2 and weight of 98.0 ± 20.2 kg. The mean percentage of total body fat was 45.0 ± 5.5% in women and 32.5 ± 5.5% in men. Obesity was associated with the severity of OSA, expressed by apnea/hypopnea index. We further found that the waist-to-hip ratio in women, but the neck circumference or percentage of body fat in men, characterizes best the OSA patients. Referring to dietary habits, half of the patients consumed white bread on a daily basis, 35.8% of them had whole grain bread in the diet, and only 16.8% consumed fish at least two portions a week. A third of patients used butter as a spread for bread or a source of fat for cooking, 2.9% of them used soft margarine, and 20.4% used olive or canola oil. Fruits and vegetables were consumed by 60% and 38% of patients, respectively. Refined sugar and sweets were used by 31.4% of patients every day. We conclude that excessive body weight, which may portend the development of OSA, is characterized by different anthropometric variables in men and women. Further, improper dietary habits seem conducive to the gain in body weight and thus may be at play in the pathogenesis of OSA.