Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-25 @ 11:53 AM
Study NCT ID:
NCT04466761
Status:
TERMINATED
Last Update Posted:
2024-11-12
First Post:
2020-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ascending Glycan Dietary Supplementation in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'The IRB closed the protocol. PI failed to submit study for continuing review.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2020-06-26', 'studyFirstSubmitQcDate': '2020-07-07', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterize Immunoglobulin fragment crystallization modifications', 'timeFrame': '4 Weeks', 'description': 'Use mass spectrometry and RNA sequencing from subject blood samples to characterize site specific glycosylation on Immunoglobulin A, Immunoglobulin M, and Immunoglobulin G.'}, {'measure': 'Identify the maximum effective dose', 'timeFrame': '16 Weeks', 'description': 'Identify maximum effective dose of dietary supplement in grams/day.'}], 'secondaryOutcomes': [{'measure': 'Assess for potential adverse events', 'timeFrame': '2 Months after first dose', 'description': 'Monitor symptoms, severity, and duration of adverse events.'}, {'measure': 'Quantification of enzymatic modifications measured in grams by spectrometry', 'timeFrame': '6 Months', 'description': 'The investigators will measure enzymatic changes on glycoproteins in the immune system by spectrometry, i.e., these changes will be measured in grams. Spectometry will allow the investigators to quantify these changes in small detail, and therefore give a better idea of how supplementation can change enzymatic process that then affect the structure, and mass, of glycoproteins.'}, {'measure': 'Flow cytometry to determine the effect of dietary supplementation on the immune system', 'timeFrame': '6 Months', 'description': 'Perform flow cytometry on subject blood samples to determine the effect of dietary supplement on immune system. For example, the investigators will note changes to immune cell pro-inflammatory and anti-inflammatory cytokine clusters as translated proteins (measured as height and area of cytokine intensity).'}, {'measure': 'Transcriptome analysis to determine the effect of dietary supplementation on the immune system', 'timeFrame': '6 Months', 'description': 'Perform transcriptome analysis on subject blood samples to determine the effect of dietary supplement on immune system. For example, the investigators will note changes to immune cell pro-inflammatory and anti-inflammatory cytokine clusters as RNA (measure on a logarithmic scale per number of reads) to determine the effects of supplementation on both gene transcription and translation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Adults', 'Dietary supplements'], 'conditions': ['Healthy Individuals']}, 'descriptionModule': {'briefSummary': 'The investigators will conduct a parallel-group, placebo-controlled, randomized, double-blind ascending dose Phase I study of dietary supplementation in healthy individuals to evaluate safety and to determine the pharmacologically effective dose (ED).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be 18-45 years of age\n* Patients who are in general good health\n* Body Mass Index (BMI) range of 18.5-25\n* All individuals must have the ability to provide inform consent\n\nExclusion Criteria:\n\n* Women who are pregnant, actively nursing, or pregnant within the last year\n* Women who are peri-menopausal or post-menopausal\n* Women with irregular menstrual cycles (more frequently than every 21 days or lasts longer than 8 days (missed, early, or late periods are also considered signs of an irregular cycle).\n* Women on hormonal contraception, including birth control, hormonal intrauterine device, or contraceptive implant\n* Past medical history of an autoimmune condition or malignancy, excluding non-melanoma skin cancer\n* Individuals with first degree relative with history of an autoimmune condition\n* Individuals with cardiovascular, pulmonary, reproductive, endocrine, metabolic, neurologic, gastrointestinal, hematologic, or infectious diseases of any kind\n* Individuals with diagnosis of galactosemia or congenital disorders of glycosylation\n* Individuals with phenylketonuria\n* Individuals currently taking prescription medications, or have taken prescription medications within the last 3 months\n* Individuals currently taking over the counter medications\n* Individuals currently taking or have taken supplements including herbal, protein or vitamin supplements in the last 3 months (e.g. whey protein, St. John\'s Wort, green tea supplements, biotin, creatine supplements), excluding multivitamins or essential vitamins\n* Individuals with prior history of severe food or drug allergic reactions\n* Individuals with a diagnosis of type I or II diabetes mellitus\n* Individuals with allergic reaction or adverse reaction to shellfish, N-acetyl glucosamine, galactose, or Spirulina/chlorella/algae supplements\n* Individuals with social history of current use of tobacco, alcohol or other drugs\n* Individuals with dietary restrictions (vegetarians are permitted to participate in the study) or to whom any of the following dietary habits or characteristics apply (the following exclusion criteria are placed to minimize variability in diet in our study population):\n\n * Actively dieting or trying to lose weight\n * Vegan diet\n * Consume equal to or greater than 2 cups of tea a day\n * Consume equal to or greater than 4 cups of coffee a day\n * Consume equal to or greater than 3 cups of fruit juice a day\n * Practice intensive exercise patterns (marathon training, workouts \\>4 hours a day)\n * Consume soda or energy drinks of any amount\n * On a carbohydrate-restricted or "Paleo" diet\n * Calorie-restricted diet (less than 20%-25% of maintenance calories)'}, 'identificationModule': {'nctId': 'NCT04466761', 'briefTitle': 'Ascending Glycan Dietary Supplementation in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Phase I Ascending Dose Study of Dietary Supplementation With Glycan Monomers in Healthy Adults', 'orgStudyIdInfo': {'id': '1516913'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Cohort 1-4', 'description': '60% of subjects per cohort will consume 30-90 grams of dietary supplement daily for 4 weeks, with each successive cohort dosage increasing according to a Fibonacci dose escalation.', 'interventionNames': ['Dietary Supplement: Monosaccharide Powder']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo: Cohort 1-4', 'description': '40% of subjects per cohort will consume 30-90 grams of daily placebo for 4 weeks with each successive cohort dosage increasing in parallel to the experimental arm.', 'interventionNames': ['Other: Placebo Comparator']}], 'interventions': [{'name': 'Monosaccharide Powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Monosaccharide powder dissolved in water.', 'armGroupLabels': ['Experimental: Cohort 1-4']}, {'name': 'Placebo Comparator', 'type': 'OTHER', 'description': 'Placebo (cellulose powder).', 'armGroupLabels': ['Placebo: Cohort 1-4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95630', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Emanual Maverakis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}