Mediterranean Diet and Mushrooms

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.

Study Overview

• Status: Completed
• Conditions: Diet, Healthy
• Intervention / Treatment: Other: Mediterranean Diet -- Mushrooms; Other: Mediterranean Diet -- Control

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • West Lafayette, Indiana, United States, 47906
      • Purdue University
    • West Lafayette, Indiana, United States, 47907
      • Purdue University - Stone Hall 700 W State St

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mushroom intervention; Subjects will be randomized and assigned to consume the Mediterranean Diet with mushrooms for eight weeks.	Other: 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.
Active Comparator: Control; Subjects will be randomized and assigned to consume the Mediterranean Diet without mushrooms for eight weeks.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Purdue University
• Collaborators: Mushroom Council
• Investigators: Principal Investigator: Wayyne Campbell, PhD, Purdue University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Mediterranean; Mushrooms
• Other Study ID Numbers: IRB-2019-650

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No