Mediterranean Diet and Mushrooms

Not Applicable

Completed

• Conditions: Diet, Healthy

• Registration Number: NCT04259229
• Lead Sponsor: Purdue University

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-06
• Study Start: 2021-01-01
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Body weight	8 weeks	Measures of weight (kg)
Gut microbiota	8 weeks	Stool samples

Trial Locations

Locations (2)

Purdue University; 🇺🇸 West Lafayette, Indiana, United States

Purdue University - Stone Hall 700 W State St; 🇺🇸 West Lafayette, Indiana, United States