Mediterranean Diet and Mushrooms

Purdue University53 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Enrollment

Conditions

Diet, Healthy

Interventions

Mediterranean Diet -- MushroomsOTHER

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.

Mediterranean Diet -- ControlOTHER

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 69 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Purdue University

West Lafayette, Indiana, United States

Purdue University - Stone Hall 700 W State St

West Lafayette, Indiana, United States

Outcomes

Primary Outcomes

Change in perceived depression from baseline to post-intervention

Beck's Depression Inventory questionnaire

Time frame: 8 weeks

Change in perceived depression from baseline to post-intervention

Patient Health Questionnaire-9

Time frame: 8 weeks

Change in perceived anxiety from baseline to post-intervention

General Anxiety Disorder-7 questionnaire

Time frame: 8 weeks

Change in cognitive function from baseline to post-intervention

Repeatable Battery for the Assessment of Neuropsychological Status

Time frame: 8 weeks

Change in perceived daily mood from baseline to post-intervention

Profile of Mood States

Time frame: 8 weeks

Change in perceived quality of life from baseline to post-intervention

Medical Outcomes Study 36-Item Short Form Health Survey Version 2

Time frame: 8 weeks

Risk factors for cardiovascular disease

Blood pressure

Time frame: 8 weeks

Risk factors for cardiovascular disease

Complete metabolic panel

Time frame: 8 weeks

Risk factors for cardiovascular disease

Lipoprotein Particle Plus (LPP+) Panel

Time frame: 8 weeks

Data from ClinicalTrials.gov

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Mediterranean Diet and Mushrooms

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes