Mediterranean Diet and Mushrooms

Study Overview
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Brief Summary
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The investigators propose to assess the effects of including mushrooms as part of a healthy eating pattern on indices of perceived mental health/anxiety/depression, along with risk factors for cardiovascular disease and type 2 diabetes.

Detailed Description
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The investigators hypothesize that consuming mushrooms as part of a healthy eating pattern will lead to greater improvements in fasting insulin concentrations and systolic and diastolic blood pressures. The brain health-related outcomes and other cardiometabolic risk outcomes (e.g. lipoprotein particle size) are exploratory due to the paucity of human research addressing these important topics. Collectively, this short-term (8-week) randomized, controlled feeding trial will provide important pilot data to inform the plausibility, focus, and design of longer-term intervention trials, consistent with The Mushroom Council's research agenda.

Official Title
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Mediterranean Diet and Mushrooms

Conditions
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Diet, Healthy

Intervention / Treatment
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* Other: Mediterranean Diet -- Mushrooms
* Other: Mediterranean Diet -- Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female; age 30-69 y; BMI: 25.0-34.9 kg/m2; Not severely or extremely depressed (Beck's Depression Inventory score ≤30) Total cholesterol <240 mg/dL, low-density lipoprotein cholesterol <160 mg/dL, triglycerides <400 mg/dL, fasting glucose <110 mg/dL; Systolic/diastolic blood pressure <140/90 mm Hg; Body weight stable for 3 months prior (± 3 kg); Stable physical activity regimen 3 months prior; Medication use stable for 6 months prior; Non-smoking; Non-diabetic; Not acutely ill; Females not pregnant or lactating; Participants must be willing and able to consume the prescribed diets and travel to testing facilities. Exclusion Criteria: BMI <25 or >35; Severely depressed (Beck's Depression Inventory score >30); Total cholesterol >240 mg/dL, low-density lipoprotein cholesterol >160 mg/dL, triglycerides >400 mg/dL, fasting glucose >110 mg/dL; Body weight changes in previous 3 months (±3 kg); Changes in physical activity regimen in the previous 3 months; Medication changes in the previous 6 months; Smoking; Diabetic; Acute illness; Pregnant or lactating; Allergic to mushrooms

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: For this investigator-blinded, randomized, parallel design study, 100 participants (60 to finish; n=30/group) will complete a 10-week study period, which includes a 2-week baseline testing period (no diet control), followed by an 8-week controlled diet period (Figure 1). In order to define the effects of adding mushrooms to a healthy dietary pattern on fasting blood glucose and insulin concentrations and blood pressures, we will provide a Mediterranean-style diet devoid of mushrooms as the control diet for this study. Questionnaires assessing depression/anxiety, perceived quality of life, and mood will be administered and the results will provide a foundation to power future, more robust, studies.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mushroom intervention<br>Subjects will be randomized and assigned to consume the Mediterranean Diet with mushrooms for eight weeks. | Other: Mediterranean Diet -- Mushrooms<br>* During the 2-week baseline period all participants will consume their usual, unrestricted self-chosen diets. During intervention weeks 1-8, all participants will consume the same Mediterranean-style diet, rich in fruits and seafoods and lower in dairy, designed to meet their estimated energy needs. The mushroom group will consume 0.5 cups/day of cooked mushrooms (white button mushrooms and yellow oyster mushrooms on 4 and 3 days/week, respectively). All foods will be provided to subjects during the intervention to achieve the desired eating pattern.<br>|
| Active Comparator: Control<br>Subjects will be randomized and assigned to consume the Mediterranean Diet without mushrooms for eight weeks. | Other: Mediterranean Diet -- Control<br>* During the 2-week baseline period all participants will consume their usual, unrestricted self-chosen diets. During intervention weeks 1-8, all participants will consume the same Mediterranean-style diet, rich in fruits and seafoods and lower in dairy, designed to meet their estimated energy needs. The control group will not consume mushrooms at any point. All foods will be provided to subjects during the intervention to achieve the desired eating pattern.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in perceived depression from baseline to post-intervention | Beck's Depression Inventory questionnaire | 8 weeks | 
| Change in perceived depression from baseline to post-intervention | Patient Health Questionnaire-9 | 8 weeks | 
| Change in perceived anxiety from baseline to post-intervention | General Anxiety Disorder-7 questionnaire | 8 weeks | 
| Change in cognitive function from baseline to post-intervention | Repeatable Battery for the Assessment of Neuropsychological Status | 8 weeks | 
| Change in perceived daily mood from baseline to post-intervention | Profile of Mood States | 8 weeks | 
| Change in perceived quality of life from baseline to post-intervention | Medical Outcomes Study 36-Item Short Form Health Survey Version 2 | 8 weeks | 
| Risk factors for cardiovascular disease | Blood pressure | 8 weeks | 
| Risk factors for cardiovascular disease | Complete metabolic panel | 8 weeks | 
| Risk factors for cardiovascular disease | Lipoprotein Particle Plus (LPP+) Panel | 8 weeks | 
| Risk factors for type 2 diabetes | Complete metabolic panel | 8 weeks | 
| Change in immunity/inflammation markers | Complete Cytokine 13 Panel -- all outcomes reported as pg/mL | 8 weeks | 
| Change in immunity/inflammation markers | Complete Immunoglobulin Panel -- all outcomes reported as mg/dL | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Measures of weight (kg) | 8 weeks | 
| Gut microbiota | Stool samples | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mediterranean, Mushrooms