Plant-Based Diet for Sleep Apnea

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Weight loss medications

Disqualifiers: Pregnancy, Vegan diet, BMI ≤ 22, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a plant-based diet might benefit people with obstructive sleep apnea, a condition that interrupts breathing during sleep and causes daytime sleepiness. Participants will either maintain their regular diet or switch to a whole food plant-based diet for eight weeks to determine if this change reduces symptoms. The trial suits those who often feel sleepy during the day, have been diagnosed with sleep apnea, and have not found success with other treatments. Participants should not already follow a vegan diet or have certain heart or lung conditions. As an unphased trial, this study offers a unique opportunity to explore lifestyle changes that could improve sleep apnea symptoms.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that a whole food plant-based diet is generally safe and easy for most people to follow. Studies on similar diets have found that they can help reduce daytime tiredness in people with obstructive sleep apnea, without causing major side effects. In these studies, participants reported no harmful effects from using this diet for a short time.

Additionally, plant-based diets often associate with health benefits, such as a lower risk of heart disease and better overall health, which supports their safety. However, with any dietary change, it's important to monitor how the body reacts and consult a healthcare provider if there are any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for sleep apnea, which often involve CPAP machines or oral appliances to keep airways open, a whole food plant-based diet offers a non-invasive and holistic approach to managing the condition. This diet is rich in plant-based foods, which can lead to weight loss and reduced inflammation, two factors that can significantly improve sleep apnea symptoms. Researchers are excited about this treatment because it addresses underlying health issues rather than just the symptoms, potentially offering a more sustainable and health-promoting solution.

What evidence suggests that a Whole Food Plant-Based Diet might be an effective treatment for sleep apnea?

This trial will compare a Whole Food Plant-Based Diet with usual care for sleep apnea. Research has shown that a whole food plant-based diet can help with obstructive sleep apnea (OSA). Studies suggest that people who consume more healthy plant-based foods can lower their risk of OSA by up to 19%. One study found that following this diet for just three weeks reduced daytime sleepiness in people with OSA. Overall, eating a whole food plant-based diet seems to improve sleep health and may lessen OSA symptoms. ^{1 3 4 5 6}

Who Is on the Research Team?

Joseph Cheung, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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)

Exclusion Criteria

Pregnancy or lactation

Current use of a vegan diet

BMI ≤ 22

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Whole Food Plant-Based Diet

Trial Overview 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.

How Is the Trial Designed?

Group I: Diet Group: Whole Food Plant Based Diet Experimental Treatment 1 Intervention

Subjects with follow a whole food plant-based diet for 8 weeks.

Group II: Control Group: Usual Care Active Control 1 Intervention

Subjects will not change their diet for 8 weeks.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A healthy plant-based diet (HPDI) is linked to a reduced risk of hospitalization for respiratory infections (HR 0.86) and any infections (HR 0.87) based on data from the Atherosclerosis Risk in Communities Study, which analyzed dietary intake from food frequency questionnaires.

In contrast, an unhealthy plant-based diet (UPDI) did not show significant associations with hospitalization risks, highlighting the importance of diet quality in health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plant-Based Diets and Risk of Hospitalization with Respiratory Infection: Results from the Atherosclerosis Risk in Communities (ARIC) Study. Kendrick, KN., Kim, H., Rebholz, CM., et al.[2023]

In a pilot program involving 17 participants, the adoption of a Whole Food Plant-based (WFPB) diet resulted in significant weight loss (4.3 kg) and improvements in cholesterol levels, including a decrease in total cholesterol and triglycerides, and an increase in HDL (good cholesterol).

The program, which included educational sessions led by a gastroenterologist, demonstrated the potential effectiveness of WFPB diets in a clinical setting, particularly for patients with conditions like hyperlipidemia and hypertension, suggesting a need for larger-scale studies to further validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Whole Food Plant Based Diet in a Food as Prevention Program in a Resource Constrained Environment. Ganguli, SC., Russell, LA., Tsoi, KS.[2023]

In a study of 2424 Chinese adults aged 45 and older, those with a higher adherence to healthful plant-based diets had significantly better sleep quality, with 0.55 higher odds of achieving good sleep compared to those with lower adherence.

Conversely, individuals following unhealthful plant-based diets were found to have 2.03 higher odds of experiencing poor sleep quality, indicating that the type of plant-based diet can greatly influence sleep outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of plant-based diet index with sleep quality in middle-aged and older adults: The Healthy Dance Study. Tang, S., Zhou, J., Liu, C., et al.[2023]

A study of 151 healthy participants showed that a well-planned whole-food plant-based (WFPB) diet, supplemented with meal replacements, provided adequate macro- and micronutrients, exceeding reference values for most nutrients except calcium and vitamin D.

Female participants had significantly higher intakes of 23 out of 25 micronutrients compared to males, indicating that the WFPB diet can be tailored to meet the nutritional needs of different sexes while promoting a healthy and sustainable eating pattern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrient and Food Intake of Participants in a Whole-Food Plant-Based Lifestyle Program. Jakše, B., Jakše, B., Pinter, S., et al.[2022]

A community-based dietary program using a whole food plant-based (WFPB) diet resulted in a significant reduction in BMI after 6 months, with an average decrease of 4.4 kg/m² compared to only 0.4 kg/m² in the control group.

Participants following the WFPB diet also experienced a meaningful reduction in cholesterol levels, achieving a significant decrease at 12 months, with no serious harms reported, indicating the diet's safety and potential efficacy for improving health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The BROAD study: A randomised controlled trial using a whole food plant-based diet in the community for obesity, ischaemic heart disease or diabetes. Wright, N., Wilson, L., Smith, M., et al.[2018]

In a study of 137 adults with obstructive sleep apnea (OSA), 93.4% were found to be overweight or obese, indicating a strong link between obesity and the severity of OSA, particularly measured by the apnea/hypopnea index.

The study revealed concerning dietary habits among OSA patients, with many consuming high amounts of refined sugars and low amounts of fish, suggesting that poor nutrition may contribute to weight gain and exacerbate OSA symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Status and Dietary Patterns in Adults with Severe Obstructive Sleep Apnea. Jeznach-Steinhagen, A., Okręglicka, K., Nitsch-Osuch, A., et al.[2020]

A 21-day whole-food plant-based (WFPB) diet significantly reduced daytime sleepiness in 14 patients with obstructive sleep apnea, as indicated by a mean decrease of 3.8 points on the Epworth Sleepiness Scale.

This study suggests that adopting a WFPB diet, which is low in saturated fat, may be an effective dietary intervention for alleviating symptoms of daytime sleepiness associated with obstructive sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-food plant-based diet reduces daytime sleepiness in patients with OSA. Patel, K., Lawson, M., Cheung, J.[2023]

In a study of 21 obese patients with obstructive sleep apnoea/hypopnoea syndrome, both the Mediterranean diet and a prudent diet led to a significant decrease in TBARS levels, indicating reduced oxidative stress, but there was no significant difference between the two diets.

However, the Mediterranean diet resulted in greater improvements in weight loss and body composition metrics compared to the prudent diet, suggesting it may be more beneficial for overall health in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Mediterranean diet on lipid peroxidation marker TBARS in obese patients with OSAHS under CPAP treatment: a randomised trial. Papandreou, C., Schiza, SE., Tzatzarakis, MN., et al.[2021]

A whole food plant-based diet (WFPBD) was tested on 10 patients with type 2 diabetes for 3 weeks before their surgeries, showing a decrease in fasting blood glucose (FBG) from 127 to 116 mg/dL, although this change was not statistically significant (P = .2).

Five participants experienced notable improvements in glycemic control, with an average decline of 11 mg/dL, suggesting that a WFPBD may help manage blood sugar levels in patients with type 2 diabetes before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Plant-Based Dietary Intervention for Preoperative Glucose Optimization in Diabetic Patients Undergoing Total Joint Arthroplasty. Drost, JM., Cook, CB., Spangehl, MJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10910314/

Plant-based and vegetarian diets are associated with reduced ... Higher adherence to a healthy plant-based diet is associated with reduced OSA risk, while an unhealthy plant-based diet has a positive association.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37285791/

Whole-food plant-based diet reduces daytime sleepiness ... 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 ...

3. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1239580/full

The impact of plant-rich diets on sleep: a mini-review Whole-food plant-based diet reduces daytime sleepiness in patients with OSA. Sleep Med. (2023) 107:327–9. doi: 10.1016/j.sleep.2023.05.007. PubMed Abstract ...

4. forksoverknives.com forksoverknives.com/wellness/healthy-plant-based-diets-could-slash-sleep-apnea-risk-new-study/

Plant-Based Diets Could Slash Sleep Apnea Risk by up to ... The study found that participants who ate more “healthy” plant-based foods and more plant-based foods in general were 17% and 19% less likely to ...

5. mdpi.com mdpi.com/2072-6643/16/19/3386

The Relationship between Plant-Based Diet Indices and ... Our study exhibited significant correlations between plant-based diets and sleep health in the elderly. Depression and anxiety were determined as parallel ...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20566963

Whole Food Plant-based Diet Effect on Obstructive Sleep ... The purpose of this study is to assess the level of daytime sleepiness by Epworth Sleepiness Questionnaire and changes in severity of ...