Trials / Completed
CompletedNCT04259229
Mediterranean Diet and Mushrooms
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- Purdue University · Academic / Other
- Sex
- All
- Age
- 30 Years – 69 Years
- Healthy volunteers
- Accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| OTHER | 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. |
Timeline
- Start date
- 2021-01-01
- Primary completion
- 2022-11-30
- Completion
- 2022-11-30
- First posted
- 2020-02-06
- Last updated
- 2024-02-14
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04259229. Inclusion in this directory is not an endorsement.