Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
NCT ID:
NCT05559112
Eligibility Criteria:
Inclusion Criteria:
* BMI: 25.0-34.9 kg/m\^2
* Total cholesterol \<240 mg/dL
* low density lipoprotein cholesterol \< 160 mg/dL
* triglycerides \<300 mg/dL
* fasting glucose \< 110 mg/dL
* systolic/diastolic blood pressure \< 140/90 mmHg
* body weight stable for 3 months prior (+- 3 kg)
* stable physical activity regiment 3 months prior
* medication use stable for 6 months prior
* non-smoking
* non-diabetic
* not acutely ill
* females not pregnant or lactating
* willing to refrain from taking vitamin D supplements or any supplements containing vitamin D
* No history of bariatric surgery
* Not extremely or severely depressed (Beck's Depression Inventory Score \<= 30)
* Agree not to donate blood for at least one month prior to, during, and for one month after the study
* Agree not to travel to sunny locations during the study period
* Agree to forgo any tanning bed or other tanning procedures during the study
* Willing and able to consume mushrooms and travel to testing facilities
Exclusion Criteria:
* Age \<30 or \>70
* BMI \<25 or \>35kg/m2
* Total cholesterol \>240 mg/dL, low-density lipoprotein cholesterol \>160 mg/dL, triglycerides \>300mg/dL, fasting glucose \>110 mg/dL
* Systolic/diastolic blood pressure \>140/90 mm Hg
* 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
* Extremely or severely depressed (Beck's Depression Inventory Score \>30)
* Unwilling to refrain from taking vitamin D supplements or any supplements containing vitamin D
* Regiment of megadosing vitamin D
* Unwilling to not to travel to sunny locations during the study period
* Unwilling to forgo any tanning bed or other tanning procedures during the study
* History of bariatric surgery
* Consuming a restricted diet (such as keto, gluten free, high protein, low carb, etc.)
* Smoking
* Diabetic
* Acute illness
* Females pregnant or lactating
* Unwilling to not to donate blood for at least one month prior to, during, and for one month after the study
* Allergic to mushrooms or bread
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
69 Years
Study:
NCT05559112
Study Brief:
Protocol Section:
NCT05559112