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

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 6 7}

How 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. ^{1 2 3 8 9}

Research Team

Joseph Cheung, MD

Principal Investigator

Mayo Clinic

Eligibility 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)

Exclusion Criteria

Pregnancy or lactation

Current use of a vegan diet

BMI ≤ 22

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Implementation of a Whole Food Plant Based Diet in a Food as Prevention Program in a Resource Constrained Environment. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Whole-food plant-based diet reduces daytime sleepiness in patients with OSA. [2023]

3. England 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. [2018]

4. Germany 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

A Plant-Based Dietary Intervention for Preoperative Glucose Optimization in Diabetic Patients Undergoing Total Joint Arthroplasty. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Plant-Based Diets and Risk of Hospitalization with Respiratory Infection: Results from the Atherosclerosis Risk in Communities (ARIC) Study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Nutrient and Food Intake of Participants in a Whole-Food Plant-Based Lifestyle Program. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Association of plant-based diet index with sleep quality in middle-aged and older adults: The Healthy Dance Study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Nutritional Status and Dietary Patterns in Adults with Severe Obstructive Sleep Apnea. [2020]