Clinical trial NCT04259229: Mediterranean Diet and Mushrooms
Official title: Mediterranean Diet and Mushrooms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Keywords: Mediterranean
Mushrooms
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Mushroom Council
First posted: 2020-02-06
Enrollment: 53
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in perceived depression from baseline to post-intervention
timeFrame: 8 weeks
measure: Change in perceived depression from baseline to post-intervention
timeFrame: 8 weeks
measure: Change in perceived anxiety from baseline to post-intervention
timeFrame: 8 weeks
measure: Change in cognitive function from baseline to post-intervention
timeFrame: 8 weeks
measure: Change in perceived daily mood from baseline to post-intervention
timeFrame: 8 weeks
measure: Change in perceived quality of life from baseline to post-intervention
timeFrame: 8 weeks
measure: Risk factors for cardiovascular disease
timeFrame: 8 weeks
measure: Risk factors for cardiovascular disease
timeFrame: 8 weeks
measure: Risk factors for cardiovascular disease
timeFrame: 8 weeks
measure: Risk factors for type 2 diabetes
timeFrame: 8 weeks
measure: Change in immunity/inflammation markers
timeFrame: 8 weeks
measure: Change in immunity/inflammation markers
timeFrame: 8 weeks
Secondary outcomes:
measure: Body weight
timeFrame: 8 weeks
measure: Gut microbiota
timeFrame: 8 weeks
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
city: West Lafayette
country: United States
facility: Purdue University - Stone Hall 700 W State St
state: Indiana
Study officials:
affiliation: Purdue University
name: Wayyne Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References: