Mediterranean Diet and Mushrooms
- Conditions
- Diet, Healthy
- Interventions
- Other: Mediterranean Diet -- ControlOther: Mediterranean Diet -- Mushrooms
- Registration Number
- NCT04259229
- Lead Sponsor
- Purdue University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Mediterranean Diet -- Control Subjects will be randomized and assigned to consume the Mediterranean Diet without mushrooms for eight weeks. Mushroom intervention Mediterranean Diet -- Mushrooms Subjects will be randomized and assigned to consume the Mediterranean Diet with mushrooms for eight weeks.
- Primary Outcome Measures
Name Time Method Change in cognitive function from baseline to post-intervention 8 weeks Repeatable Battery for the Assessment of Neuropsychological Status
Risk factors for type 2 diabetes 8 weeks Complete metabolic panel
Change in perceived quality of life from baseline to post-intervention 8 weeks Medical Outcomes Study 36-Item Short Form Health Survey Version 2
Change in perceived anxiety from baseline to post-intervention 8 weeks General Anxiety Disorder-7 questionnaire
Change in perceived daily mood from baseline to post-intervention 8 weeks Profile of Mood States
Risk factors for cardiovascular disease 8 weeks Lipoprotein Particle Plus (LPP+) Panel
Change in perceived depression from baseline to post-intervention 8 weeks Patient Health Questionnaire-9
Change in immunity/inflammation markers 8 weeks Complete Immunoglobulin Panel -- all outcomes reported as mg/dL
- Secondary Outcome Measures
Name Time Method Body weight 8 weeks Measures of weight (kg)
Gut microbiota 8 weeks Stool samples
Trial Locations
- Locations (2)
Purdue University - Stone Hall 700 W State St
🇺🇸West Lafayette, Indiana, United States
Purdue University
🇺🇸West Lafayette, Indiana, United States