Mediterranean Diet and Mushrooms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-11-30

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.

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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.

Conditions

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Diet, Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators

Study Groups

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Mushroom intervention

Subjects will be randomized and assigned to consume the Mediterranean Diet with mushrooms for eight weeks.

Group Type EXPERIMENTAL

Mediterranean Diet -- Mushrooms

Intervention Type OTHER

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.

Control

Subjects will be randomized and assigned to consume the Mediterranean Diet without mushrooms for eight weeks.

Group Type ACTIVE_COMPARATOR

Mediterranean Diet -- Control

Intervention Type OTHER

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.

Interventions

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Mediterranean Diet -- Mushrooms

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.

Intervention Type OTHER

Mediterranean Diet -- Control

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.

Intervention Type OTHER

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes