Mediterranean Diet and Mushrooms

Purdue University

Status: Completed

Conditions: Diet, Healthy

Treatments: Other: Mediterranean Diet -- Control; Other: Mediterranean Diet -- Mushrooms

Study type: Interventional

Funder types: Other

Identifiers

NCT04259229

IRB-2019-650

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 53 patients

Sex: All

Ages: 30 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 2 patient groups

Mushroom intervention

Experimental group

Description:

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

Treatment:

Other: Mediterranean Diet -- Mushrooms

Control

Active Comparator group

Description:

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

Treatment:

Other: Mediterranean Diet -- Control