Diet, HealthyNCT04259229

Mediterranean Diet and Mushrooms

A study testing Mediterranean Diet -- Mushrooms in people with Diet, Healthy, run by Purdue University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 30 to 69 yearsHealthy volunteers can take part
Conditions the study is for: Diet, Healthy
What is being tested?: Mediterranean Diet -- Mushrooms
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 2 sitesUnited States
Study dates: 1 Jan 2021to 30 Nov 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 69 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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;

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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.

Who cannot join

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;

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Smoking;
Diabetic;
Acute illness;
Pregnant or lactating;
Allergic to mushrooms

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Purdue University
West Lafayette, Indiana, 47906
Purdue University - Stone Hall 700 W State St
West Lafayette, Indiana, 47907

Other trials in United States

About this study

Read the 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: Diet, Healthy
Being tested: Mediterranean Diet -- Mushrooms, Mediterranean Diet -- Control
Keywords: Mediterranean, Mushrooms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mediterranean Diet -- MushroomsOther
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 -- ControlOther
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.

Study groups in NCT04259229
Study group	Role	What they receive
Mushroom intervention	Experimental	Subjects will be randomized and assigned to consume the Mediterranean Diet with mushrooms for eight weeks. Receives: Other: Mediterranean Diet -- Mushrooms
Control	Active comparator	Subjects will be randomized and assigned to consume the Mediterranean Diet without mushrooms for eight weeks. Receives: Other: Mediterranean Diet -- Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in perceived depression from baseline to post-intervention
Beck's Depression Inventory questionnaire
Measured: 8 weeks
Change in perceived depression from baseline to post-intervention
Patient Health Questionnaire-9
Measured: 8 weeks
Change in perceived anxiety from baseline to post-intervention
General Anxiety Disorder-7 questionnaire
Measured: 8 weeks
Change in cognitive function from baseline to post-intervention
Repeatable Battery for the Assessment of Neuropsychological Status
Measured: 8 weeks
Change in perceived daily mood from baseline to post-intervention
Profile of Mood States
Measured: 8 weeks
Change in perceived quality of life from baseline to post-intervention
Medical Outcomes Study 36-Item Short Form Health Survey Version 2
Measured: 8 weeks
Risk factors for cardiovascular disease
Blood pressure
Measured: 8 weeks
Risk factors for cardiovascular disease
Complete metabolic panel
Measured: 8 weeks
Risk factors for cardiovascular disease
Lipoprotein Particle Plus (LPP+) Panel
Measured: 8 weeks
Risk factors for type 2 diabetes
Complete metabolic panel
Measured: 8 weeks
Change in immunity/inflammation markers
Complete Cytokine 13 Panel -- all outcomes reported as pg/mL
Measured: 8 weeks
Change in immunity/inflammation markers
Complete Immunoglobulin Panel -- all outcomes reported as mg/dL
Measured: 8 weeks

Secondary outcomes (2)

Body weight
Measures of weight (kg)
Measured: 8 weeks
Gut microbiota
Stool samples
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202130 Nov 2022

First posted6 Feb 2020
Study start1 Jan 2021
Primary completion30 Nov 2022
Study completion30 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diet, HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Single blind
Who is masked: Investigator
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04259229
Sponsor's protocol ID: IRB-2019-650
Status last verified: Feb 2024
First submitted: 19 Dec 2019
Last updated: 14 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 38135005

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mediterranean Diet and Mushrooms
ClinicalTrials.gov ID: NCT04259229
Acronym / sponsor ID: IRB-2019-650
Conditions: Diet, Healthy
Keywords: Mediterranean, Mushrooms
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Purdue UniversityUniversity, hospital or other
Collaborators: Mushroom Council
Study start: 1 Jan 2021 (actual)
Primary completion: 30 Nov 2022 (actual)
Study completion: 30 Nov 2022 (actual)
First posted: 6 Feb 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
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.

Arm	Type	Receives
Mushroom intervention	Experimental	Other: Mediterranean Diet -- MushroomsSubjects will be randomized and assigned to consume the Mediterranean Diet with mushrooms for eight weeks.
Control	Active comparator	Other: Mediterranean Diet -- ControlSubjects will be randomized and assigned to consume the Mediterranean Diet without mushrooms for eight weeks.

Who may qualify

Ages: 30 to 69 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

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;

Key exclusion criteria (11 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mediterranean Diet -- MushroomsDuring 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	Mushroom intervention
Mediterranean Diet -- ControlDuring 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.	Other	Control

Primary outcome

Change in perceived depression from baseline to post-intervention
Time frame: 8 weeks
Beck's Depression Inventory questionnaire
Change in perceived depression from baseline to post-intervention
Time frame: 8 weeks
Patient Health Questionnaire-9
Change in perceived anxiety from baseline to post-intervention
Time frame: 8 weeks
General Anxiety Disorder-7 questionnaire
Change in cognitive function from baseline to post-intervention
Time frame: 8 weeks
Repeatable Battery for the Assessment of Neuropsychological Status
Change in perceived daily mood from baseline to post-intervention
Time frame: 8 weeks
Profile of Mood States
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
Risk factors for cardiovascular disease
Time frame: 8 weeks
Blood pressure
Risk factors for cardiovascular disease
Time frame: 8 weeks
Complete metabolic panel
Risk factors for cardiovascular disease
Time frame: 8 weeks
Lipoprotein Particle Plus (LPP+) Panel
Risk factors for type 2 diabetes
Time frame: 8 weeks
Complete metabolic panel
Change in immunity/inflammation markers
Time frame: 8 weeks
Complete Cytokine 13 Panel -- all outcomes reported as pg/mL
Change in immunity/inflammation markers
Time frame: 8 weeks
Complete Immunoglobulin Panel -- all outcomes reported as mg/dL

2 secondary outcomes

Body weight
Time frame: 8 weeks
Gut microbiota
Time frame: 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
Derived from this study: PubMed 38135005Uffelman 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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Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wayyne Campbell, PhD principal investigator

Purdue University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mediterranean Diet -- Mushrooms in people with Diet, Healthy, run by Purdue University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in perceived depression from baseline to post-intervention (time frame: 8 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04259229, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.