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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04259229
Other study ID # IRB-2019-650
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date November 30, 2022

Study information

Verified date February 2024
Source Purdue University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date November 30, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 69 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Purdue University West Lafayette Indiana
United States Purdue University - Stone Hall 700 W State St West Lafayette Indiana

Sponsors (2)

Lead Sponsor Collaborator
Purdue University Mushroom Council

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in perceived depression from baseline to post-intervention Beck's Depression Inventory questionnaire 8 weeks
Primary Change in perceived depression from baseline to post-intervention Patient Health Questionnaire-9 8 weeks
Primary Change in perceived anxiety from baseline to post-intervention General Anxiety Disorder-7 questionnaire 8 weeks
Primary Change in cognitive function from baseline to post-intervention Repeatable Battery for the Assessment of Neuropsychological Status 8 weeks
Primary Change in perceived daily mood from baseline to post-intervention Profile of Mood States 8 weeks
Primary Change in perceived quality of life from baseline to post-intervention Medical Outcomes Study 36-Item Short Form Health Survey Version 2 8 weeks
Primary Risk factors for cardiovascular disease Blood pressure 8 weeks
Primary Risk factors for cardiovascular disease Complete metabolic panel 8 weeks
Primary Risk factors for cardiovascular disease Lipoprotein Particle Plus (LPP+) Panel 8 weeks
Primary Risk factors for type 2 diabetes Complete metabolic panel 8 weeks
Primary Change in immunity/inflammation markers Complete Cytokine 13 Panel -- all outcomes reported as pg/mL 8 weeks
Primary Change in immunity/inflammation markers Complete Immunoglobulin Panel -- all outcomes reported as mg/dL 8 weeks
Secondary Body weight Measures of weight (kg) 8 weeks
Secondary Gut microbiota Stool samples 8 weeks
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