Mediterranean Diet and Mushrooms

NCT04259229 | Completed

• 1 other identifier: IRB-2019-650
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

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.

Conditions

Diet, Healthy

Keywords

Mediterranean; Mushrooms

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (2)

• Body weight

  8 weeks

• Gut microbiota

  8 weeks

Study Arms (2)

Mushroom intervention

EXPERIMENTAL

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

Other: Mediterranean Diet -- Mushrooms

Control

ACTIVE COMPARATOR

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

Other: Mediterranean Diet -- Control

Interventions

Mediterranean Diet -- Mushrooms OTHER

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.

Mushroom intervention

Mediterranean Diet -- Control OTHER

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.

Control

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Purdue University: lead
• Mushroom Council: collaborator

Study Sites (2)

Purdue University

West Lafayette, Indiana, 47906, United States

Location

Purdue University - Stone Hall 700 W State St

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

• Uffelman CN, Schmok JN, Campbell RE, Hartman AS, Olson MR, Anderson NL, Reisdorph NA, Tang M, Krebs NF, Campbell WW. Consuming Mushrooms When Adopting a Healthy Mediterranean-Style Dietary Pattern Does Not Influence Short-Term Changes of Most Cardiometabolic Disease Risk Factors in Healthy Middle-Aged and Older Adults. J Nutr. 2024 Feb;154(2):574-582. doi: 10.1016/j.tjnut.2023.12.026. Epub 2023 Dec 20.

  PMID: 38135005 DERIVED

Study Officials

• Wayyne Campbell, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: For this investigator-blinded, randomized, parallel design study, 100 participants (60 to finish; n=30/group) will complete a 10-week study period, which includes a 2-week baseline testing period (no diet control), followed by an 8-week controlled diet period (Figure 1). In order to define the effects of adding mushrooms to a healthy dietary pattern on fasting blood glucose and insulin concentrations and blood pressures, we will provide a Mediterranean-style diet devoid of mushrooms as the control diet for this study. Questionnaires assessing depression/anxiety, perceived quality of life, and mood will be administered and the results will provide a foundation to power future, more robust, studies.

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: February 6, 2020
• Study Start: January 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

US (2)