Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT05559112
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2022-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Vitamin D-Enriched Mushrooms on Vitamin D Status and Immune Function and Inflammatory Status in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "For this investigator-blinded, randomized, parallel design study, 50 participants (40 to finish; n=20/group) will complete a 12-week study period in which participants consume 84 g of vitamin-D enriched mushrooms containing 800 IU/serving or study powder (control) in the context of their usual diet. To assess the effects of including vitamin D-enriched mushrooms as part of participants' usual eating pattern on serum vitamin D status and indices of immune function and inflammatory status, we will measure circulating concentrations of 25-hydroxy-vitamin D2, pro- and anti-inflammatory cytokines, and immunoglobulins, among other immunity/inflammation outcomes. Health questionnaires related to perceived anxiety/depression and wellbeing are included to complement the currently funded longitudinal feeding study which includes these exploratory outcomes."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2022-09-26', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum 25-hydroxy-vitamin D2 concentration', 'timeFrame': '12 weeks', 'description': '25(OH) Vitamin D2/D3 by LC/MS'}], 'secondaryOutcomes': [{'measure': 'Change in immunity/inflammation markers', 'timeFrame': '12 weeks', 'description': 'Immunoglobulin G, Immunoglobulin A, Immunoglobulin M (mg/dL)'}, {'measure': 'Change in immunity/inflammation markers', 'timeFrame': '12 weeks', 'description': 'High Sensitivity C Reactive Protein (hs-CRP)'}, {'measure': 'Change in immunity/inflammation markers', 'timeFrame': '12 weeks', 'description': 'Cytokine 13 Panel (pg/mL)'}, {'measure': 'Change in bone remodeling', 'timeFrame': '12 weeks', 'description': 'Osteocalcin'}, {'measure': 'Change in serum calcium concentrations', 'timeFrame': '12 weeks', 'description': 'Parathyroid hormone (PTH)'}, {'measure': 'Change in perceived depression from baseline to mid to post-intervention', 'timeFrame': '12 weeks', 'description': "Beck's Depression Inventory questionnaire"}, {'measure': 'Change in perceived anxiety from baseline to mid to post-intervention', 'timeFrame': '12 weeks', 'description': 'Patient Health Questionnaire-9'}, {'measure': 'Change in cognitive function from baseline to mid to post-intervention', 'timeFrame': '12 weeks', 'description': 'Repeatable Battery for the Assessment of Neuropsychological Status'}, {'measure': 'Change in perceived daily mood from baseline to mid to post-intervention', 'timeFrame': '12 weeks', 'description': 'Profile of Mood States'}, {'measure': 'Change in perceived quality of life from baseline to mid to post-intervention', 'timeFrame': '12 weeks', 'description': 'Medical Outcomes Study 36-Item Short Form Health Survey Version 2'}, {'measure': 'Risk factors for cardiovascular disease', 'timeFrame': '12 weeks', 'description': 'Complete metabolic panel'}, {'measure': 'Risk factors for cardiovascular disease', 'timeFrame': '12 weeks', 'description': 'Blood pressure'}, {'measure': 'Risk factors for cardiovascular disease', 'timeFrame': '12 weeks', 'description': 'Lipoprotein Particle Plus (LPP+) Panel'}, {'measure': 'Risk factors for cardiovascular disease', 'timeFrame': '12 weeks', 'description': 'Complete blood count (CBC)'}, {'measure': 'Risk factors for type 2 diabetes', 'timeFrame': '12 weeks', 'description': 'Complete metabolic panel'}, {'measure': 'Body weight', 'timeFrame': '12 weeks', 'description': 'Measures of weight (kg)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mushroom', 'Immune function', 'Vitamin D2', 'randomized controlled trial'], 'conditions': ['Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': "We propose to assess the effects of including vitamin D-enriched mushrooms as part of participants' usual eating pattern primarily on 25(OH) vitamin D2 status and secondarily on immune function and inflammatory status.", 'detailedDescription': "We hypothesize that consuming vitamin D-enriched mushrooms daily for 12 weeks will prevent decreases in serum 25-hydroxy-vitamin D2 concentrations. Secondarily, we hypothesize consuming vitamin D-enriched mushrooms daily for 12 weeks will improve clinical indicators of inflammatory status and alter/enhance immune status and immune cell function. This short-term randomized, controlled trial will provide important data to inform the plausibility, focus, and design of longer-term intervention trials, consistent with The Mushroom Council's research agenda regarding health-promoting effects of vitamin D-enriched mushrooms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI: 25.0-34.9 kg/m\\^2\n* Total cholesterol \\<240 mg/dL\n* low density lipoprotein cholesterol \\< 160 mg/dL\n* triglycerides \\<300 mg/dL\n* fasting glucose \\< 110 mg/dL\n* systolic/diastolic blood pressure \\< 140/90 mmHg\n* body weight stable for 3 months prior (+- 3 kg)\n* stable physical activity regiment 3 months prior\n* medication use stable for 6 months prior\n* non-smoking\n* non-diabetic\n* not acutely ill\n* females not pregnant or lactating\n* willing to refrain from taking vitamin D supplements or any supplements containing vitamin D\n* No history of bariatric surgery\n* Not extremely or severely depressed (Beck's Depression Inventory Score \\<= 30)\n* Agree not to donate blood for at least one month prior to, during, and for one month after the study\n* Agree not to travel to sunny locations during the study period\n* Agree to forgo any tanning bed or other tanning procedures during the study\n* Willing and able to consume mushrooms and travel to testing facilities\n\nExclusion Criteria:\n\n* Age \\<30 or \\>70\n* BMI \\<25 or \\>35kg/m2\n* Total cholesterol \\>240 mg/dL, low-density lipoprotein cholesterol \\>160 mg/dL, triglycerides \\>300mg/dL, fasting glucose \\>110 mg/dL\n* Systolic/diastolic blood pressure \\>140/90 mm Hg\n* Body weight changes in previous 3 months (±3 kg)\n* Changes in physical activity regimen in the previous 3 months\n* Medication changes in the previous 6 months\n* Extremely or severely depressed (Beck's Depression Inventory Score \\>30)\n* Unwilling to refrain from taking vitamin D supplements or any supplements containing vitamin D\n* Regiment of megadosing vitamin D\n* Unwilling to not to travel to sunny locations during the study period\n* Unwilling to forgo any tanning bed or other tanning procedures during the study\n* History of bariatric surgery\n* Consuming a restricted diet (such as keto, gluten free, high protein, low carb, etc.)\n* Smoking\n* Diabetic\n* Acute illness\n* Females pregnant or lactating\n* Unwilling to not to donate blood for at least one month prior to, during, and for one month after the study\n* Allergic to mushrooms or bread"}, 'identificationModule': {'nctId': 'NCT05559112', 'briefTitle': 'Effects of Vitamin D-Enriched Mushrooms on Vitamin D Status and Immune Function and Inflammatory Status in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Purdue University'}, 'officialTitle': 'Effects of Vitamin D-Enriched Mushrooms on Vitamin D Status and Immune Function in Adults', 'orgStudyIdInfo': {'id': 'IRB-2022-750'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mushrooms', 'description': 'Participants will consume their usual, unrestricted, self-selected diet plus 84 g of vitamin D-enriched mushrooms twice daily for 12 weeks.', 'interventionNames': ['Other: Vitamin D-enriched mushrooms']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No Mushrooms', 'description': 'This is a behavioral control where no change in Vitamin D status is expected to occur. Participants will consume their usual, unrestricted, self-selected diet plus 1 tsp of dried study powder twice daily for 12 weeks.', 'interventionNames': ['Other: Study Powder']}], 'interventions': [{'name': 'Vitamin D-enriched mushrooms', 'type': 'OTHER', 'description': 'Participants will consume their usual, unrestricted, self-selected diet plus 84 g of vitamin D-enriched mushrooms twice daily (for a total of 168g per day) for 12 weeks.', 'armGroupLabels': ['Mushrooms']}, {'name': 'Study Powder', 'type': 'OTHER', 'description': 'Participants will consume their usual, unrestricted, self-selected diet plus 1 tsp of dried study powder twice daily (2 tsp total per day) for 12 weeks. Study powder is a commercially available carbohydrate.', 'armGroupLabels': ['No Mushrooms']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47907', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Purdue University, Department of Nutrition Science', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}], 'overallOfficials': [{'name': 'Wayne Campbell', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Purdue University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wayne Campbell', 'investigatorAffiliation': 'Purdue University'}}}}