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Completed

NCT Number: NCT04259229

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.

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Key information

Conditions

Age range

30 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University, West Lafayette, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in perceived depression from baseline to post-intervention

    Time frame: 8 weeks

    Beck's Depression Inventory questionnaire

  2. Change in perceived depression from baseline to post-intervention

    Time frame: 8 weeks

    Patient Health Questionnaire-9

  3. Change in perceived anxiety from baseline to post-intervention

    Time frame: 8 weeks

    General Anxiety Disorder-7 questionnaire

  4. Change in cognitive function from baseline to post-intervention

    Time frame: 8 weeks

    Repeatable Battery for the Assessment of Neuropsychological Status

  5. Change in perceived daily mood from baseline to post-intervention

    Time frame: 8 weeks

    Profile of Mood States

  6. Change in perceived quality of life from baseline to post-intervention

    Time frame: 8 weeks

    Medical Outcomes Study 36-Item Short Form Health Survey Version 2

  7. Risk factors for cardiovascular disease

    Time frame: 8 weeks

    Blood pressure

  8. Risk factors for cardiovascular disease

    Time frame: 8 weeks

    Complete metabolic panel

  9. Risk factors for cardiovascular disease

    Time frame: 8 weeks

    Lipoprotein Particle Plus (LPP+) Panel

  10. Risk factors for type 2 diabetes

    Time frame: 8 weeks

    Complete metabolic panel

  11. Change in immunity/inflammation markers

    Time frame: 8 weeks

    Complete Cytokine 13 Panel -- all outcomes reported as pg/mL

  12. Change in immunity/inflammation markers

    Time frame: 8 weeks

    Complete Immunoglobulin Panel -- all outcomes reported as mg/dL

Secondary outcomes

  1. Body weight

    Time frame: 8 weeks

    Measures of weight (kg)

  2. Gut microbiota

    Time frame: 8 weeks

    Stool samples

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • Mushroom Council

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2020
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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