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| Name | Class |
|---|---|
| Mushroom Council | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mushroom intervention | Experimental | Subjects will be randomized and assigned to consume the Mediterranean Diet with mushrooms for eight weeks. |
|
| Control | Active Comparator | Subjects will be randomized and assigned to consume the Mediterranean Diet without mushrooms for eight weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Measures of weight (kg) | 8 weeks |
| Gut microbiota | Stool samples | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wayyne Campbell, PhD | Purdue University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Purdue University | West Lafayette | Indiana | 47906 | United States | ||
| Purdue University - Stone Hall 700 W State St |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38135005 | Derived | 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. |
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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.
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|
| 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. |
|
| 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 |
| West Lafayette |
| Indiana |
| 47907 |
| United States |