Mediterranean Diet and Mushrooms

Diet, Healthy Clinical Trial

Official title:

Mediterranean Diet and Mushrooms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04259229
• Other study ID #: IRB-2019-650
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diet, Healthy

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