Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT07151105
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2025-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anti-inflammatory Activities of Vitamin C Supplementation on the Gut Barrier Function in Adults With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-08-27', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'alpha-Diversity (Chao1)', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention', 'description': 'Gut microbiota alpha-diversity will be determined from 16S rRNA sequencing'}, {'measure': 'alpha-Diversity (Shannon Index)', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention', 'description': 'Gut microbiota alpha-diversity will be determined from 16S rRNA sequencing'}, {'measure': 'beta-Diversity (Bray-Curtis Dissimilarity)', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention', 'description': 'Gut microbiota beta-diversity will be determined from 16S rRNA sequencing'}, {'measure': 'beta-Diversity (UniFrac)', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention', 'description': 'Gut microbiota beta-diversity will be determined from 16S rRNA sequencing'}, {'measure': 'Toll-like Receptor-4 mRNA expression', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'qPCR measure of gene expression from Peripheral Blood Mononuclear Cells isolated from whole blood'}, {'measure': 'TNF-alpha mRNA expression', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'qPCR measure of gene expression from Peripheral Blood Mononuclear Cells isolated from whole blood'}, {'measure': 'Monocyte Chemoattract Protein-1 mRNA expression', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'qPCR measure of gene expression from Peripheral Blood Mononuclear Cells isolated from whole blood'}, {'measure': 'Interleukin-6 mRNA expression', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'qPCR measure of gene expression from Peripheral Blood Mononuclear Cells isolated from whole blood'}, {'measure': 'Interleukin-8 mRNA expression', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'qPCR measure of gene expression from Peripheral Blood Mononuclear Cells isolated from whole blood'}, {'measure': 'Myeloid differentiation primary response 88 mRNA expression', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'qPCR measure of gene expression from Peripheral Blood Mononuclear Cells isolated from whole blood'}], 'primaryOutcomes': [{'measure': 'Small Intestinal Permeability', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'Urinary excretion ratio of lactulose/mannitol following oral ingestion of these sugar probes.'}], 'secondaryOutcomes': [{'measure': 'Large Intestinal Permeability', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'Urinary excretion ratio of sucralose/erythritol following oral ingestion of these sugar probes.'}, {'measure': 'Plasma Vitamin C', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'Biochemical measures of Vitamin C'}, {'measure': 'Plasma Vitamin C', 'timeFrame': 'Within-treatment arm comparison from day 0 to day 14 following 2-week intervention.', 'description': 'Biochemical measures of Vitamin C'}, {'measure': 'Fecal Calprotectin', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'Biochemical measures of Calprotectin'}, {'measure': 'Fecal Myeloperoxidase', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'Biochemical measures of Myeloperoxidase'}, {'measure': 'Fecal Butyrate', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'Biochemical measures of Butyrate'}, {'measure': 'Fecal Proprionate', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'Biochemical measures of Proprionate'}, {'measure': 'Fecal Acetate', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'Biochemical measures of Acetate'}, {'measure': 'Serum Endotoxin Concentration', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'Biochemical measure of circulating endotoxin concentration at fasting'}, {'measure': 'Plasma Lipopolysaccharide Binding Protein/Soluble Cluster of Differentiation-14', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'Biochemical measures of Lipopolysaccharide Binding Protein/Soluble Cluster of Differentiation-14 at fasting, reported as a ratio of protein concentrations'}, {'measure': 'Plasma C-Reactive Protein', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'Biochemical measures of C-Reactive Protein'}, {'measure': 'Plasma Myeloperoxidase', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'Biochemical measures of Myeloperoxidase'}, {'measure': 'Plasma Tumor Necrosis Factor-α', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'Biochemical measures of Tumor Necrosis Factor-α'}, {'measure': 'Plasma Trimethylamine N-oxide', 'timeFrame': 'Between-treatment arm comparison on day 14 following 2-week intervention.', 'description': 'Biochemical measures of Trimethylamine N-oxide'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adequate Vitamin C Status', 'Inadequate Vitamin C Status']}, 'referencesModule': {'references': [{'pmid': '30640128', 'type': 'BACKGROUND', 'citation': 'Traber MG, Buettner GR, Bruno RS. The relationship between vitamin C status, the gut-liver axis, and metabolic syndrome. Redox Biol. 2019 Feb;21:101091. doi: 10.1016/j.redox.2018.101091. Epub 2018 Dec 26.'}]}, 'descriptionModule': {'briefSummary': 'This study is testing whether taking vitamin C every day can help improve gut health and reduce inflammation in adults with obesity. Poor gut health-sometimes called "leaky gut"-can allow harmful substances from bacteria to enter the bloodstream, which may lead to inflammation and increase the risk of heart disease and liver problems.\n\nParticipants will complete two study periods, each lasting two weeks, with a two-week break in between. In one period, they will take vitamin C; in the other, a placebo. During each period, researchers will collect blood, urine, and stool samples, ask participants to track their diet and activity, and perform a test to measure gut permeability.\n\nThere are minimal risks, such as discomfort from blood draws or temporary stomach upset from a sugar drink. While participants may not directly benefit, their involvement will help researchers learn whether vitamin C is a safe and effective way to improve gut health in people with obesity.', 'detailedDescription': 'This clinical study aims to evaluate the impact of vitamin C supplementation on gut barrier function and systemic inflammation in adults with obesity. The research builds on preclinical findings that suggest vitamin C plays a critical role in maintaining gut integrity and reducing inflammation. Approximately 40% of Americans have suboptimal vitamin C status, with even higher prevalence among individuals with obesity.\n\nThe primary hypothesis is that improving vitamin C status through dietary supplementation will reduce intestinal permeability and metabolic endotoxemia. A secondary hypothesis is that vitamin C will also reduce biomarkers of intestinal inflammation and promote favorable changes in gut microbiota composition, including increased production of short-chain fatty acids (SCFAs), which are essential for intestinal health.\n\nThis randomized, double-blind, placebo-controlled crossover trial will enroll 34 obese adults (BMI 30-40 kg/m², aged 18-50 years). Participants will complete two 2-week intervention periods separated by a 2-week washout. In one period, they will receive vitamin C (500 mg capsules taken twice daily); in the other, a placebo. During both periods, participants will follow a low-vitamin C diet to minimize variability in circulating vitamin C levels.\n\nAssessments will occur on Days 0, 7, and 14 of each intervention period and include: Anthropometric measurements; Resting blood pressure; Fasting blood samples; and 3-day food records. On Day 14 of each period, participants will: Provide a stool sample and Complete a gut permeability test using a non-digestible sugar probe solution followed by a 24-hour urine collection. After the first intervention period, participants will undergo a 2-week washout before repeating the procedures with the alternate supplement.\n\nPrimary Outcome: Intestinal permeability\n\nSecondary Outcomes: Biomarkers of endotoxemia; Gut microbiota composition; Intestinal and circulating inflammation biomarkers; Plasma vitamin C concentrations; Fecal short-chain fatty acids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English speaking\n* Men and women between 18-50 years of age\n* BMI 30-40 kg/m²\n* Resting blood pressure \\<140/90 mm Hg\n* No use of multivitamin/vitamin C supplement within past 1-month\n* Non-vegetarian/non-vegan\n* Willingness to follow a diet low in fruits and vegetables for two, 2-week periods\n\nExclusion Criteria:\n\n* Current smoker or vaper, including tobacco, cannabis, or nicotine products\n* Alcohol consumption \\>2 drinks/day\n* Use of antibiotics within past 1-month\n* Use of probiotic supplements within past 1-month\n* Use of anti-inflammatory drugs within past 1-month\n* Individuals with unmanaged or poorly controlled diabetes, dyslipidemia, hypertension\n* Known history of bleeding disorders, hemochromatosis, or kidney stones\n* For Women: Pregnancy, lactation, or change in birth control within the past 3-months\n* Use of certain medications that may interact with vitamin C, including blood thinners, some antiviral drugs (e.g., indinavir), and certain antipsychotic medications (e.g., fluphenazine).'}, 'identificationModule': {'nctId': 'NCT07151105', 'briefTitle': 'Anti-inflammatory Activities of Vitamin C Supplementation on the Gut Barrier Function in Adults With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Anti-inflammatory Activities of Vitamin C Supplementation on the Gut Barrier Function in Adults With Obesity', 'orgStudyIdInfo': {'id': 'STUDY20251283'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Inadequate Vitamin C Status', 'description': 'Placebo + Low Vitamin C Diet', 'interventionNames': ['Dietary Supplement: Placebo + Low Vitamin C Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Adequate Vitamin C Status', 'description': 'Vitamin C Supplement + Low Vitamin C Diet', 'interventionNames': ['Dietary Supplement: Vitamin C Supplement + Low Vitamin C Diet']}], 'interventions': [{'name': 'Vitamin C Supplement + Low Vitamin C Diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will receive a vitamin C supplement (1000 mg/d) while following a low vitamin C diet to achieve adequate vitamin C status in a blinded manner. This will be compared to participants receiving a placebo while following a low vitamin C diet that is expected to maintain inadequate vitamin C status.', 'armGroupLabels': ['Adequate Vitamin C Status']}, {'name': 'Placebo + Low Vitamin C Diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will receive a placebo while following a low vitamin C diet to achieve inadequate vitamin C status in a blinded manner. This will be compared to participants receiving a vitamin C supplement while following a low vitamin C diet that is expected to maintain adequate vitamin C status.', 'armGroupLabels': ['Inadequate Vitamin C Status']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'NutritionClinicalTrials@osu.edu', 'phone': '614-292-4751'}], 'overallOfficials': [{'name': 'Richard Bruno, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Although no formal plan for sharing is established, data will be shared upon reasonable request and when in accordance with regulatory compliance considerations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Richard Bruno', 'investigatorAffiliation': 'Ohio State University'}}}}