[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604560":3},{"organization":4,"outcomesModule":7,"designInfo":79,"detailedDescription":90,"studyPopulation":82,"armGroups":91,"interventions":104,"overallOfficials":112,"centralContacts":116,"locations":122,"responsibleParty":137,"collaborators":82,"id":140,"slug":141,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":82,"eligibilityCriteria":145,"healthyVolunteers":142,"sex":146,"minAge":147,"maxAge":148,"enrollmentInfo":149,"targetDuration":82,"studyType":152,"phases":153,"briefSummary":155,"conditions":156,"keywords":82,"overallStatus":125,"whyStopped":82,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Ohio State University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":54},[9],{"measure":10,"description":11,"timeFrame":12},"Small Intestinal Permeability","Urinary excretion ratio of lactulose\u002Fmannitol following oral ingestion of these sugar probes.","Between-treatment arm comparison on day 14 following 2-week intervention.",[14,17,20,22,25,28,31,34,37,40,43,46,48,51],{"measure":15,"description":16,"timeFrame":12},"Large Intestinal Permeability","Urinary excretion ratio of sucralose\u002Ferythritol following oral ingestion of these sugar probes.",{"measure":18,"description":19,"timeFrame":12},"Plasma Vitamin C","Biochemical measures of Vitamin C",{"measure":18,"description":19,"timeFrame":21},"Within-treatment arm comparison from day 0 to day 14 following 2-week intervention.",{"measure":23,"description":24,"timeFrame":12},"Fecal Calprotectin","Biochemical measures of Calprotectin",{"measure":26,"description":27,"timeFrame":12},"Fecal Myeloperoxidase","Biochemical measures of Myeloperoxidase",{"measure":29,"description":30,"timeFrame":12},"Fecal Butyrate","Biochemical measures of Butyrate",{"measure":32,"description":33,"timeFrame":12},"Fecal Proprionate","Biochemical measures of Proprionate",{"measure":35,"description":36,"timeFrame":12},"Fecal Acetate","Biochemical measures of Acetate",{"measure":38,"description":39,"timeFrame":12},"Serum Endotoxin Concentration","Biochemical measure of circulating endotoxin concentration at fasting",{"measure":41,"description":42,"timeFrame":12},"Plasma Lipopolysaccharide Binding Protein\u002FSoluble Cluster of Differentiation-14","Biochemical measures of Lipopolysaccharide Binding Protein\u002FSoluble Cluster of Differentiation-14 at fasting, reported as a ratio of protein concentrations",{"measure":44,"description":45,"timeFrame":12},"Plasma C-Reactive Protein","Biochemical measures of C-Reactive Protein",{"measure":47,"description":27,"timeFrame":12},"Plasma Myeloperoxidase",{"measure":49,"description":50,"timeFrame":12},"Plasma Tumor Necrosis Factor-α","Biochemical measures of Tumor Necrosis Factor-α",{"measure":52,"description":53,"timeFrame":12},"Plasma Trimethylamine N-oxide","Biochemical measures of Trimethylamine N-oxide",[55,59,61,64,66,69,71,73,75,77],{"measure":56,"description":57,"timeFrame":58},"alpha-Diversity (Chao1)","Gut microbiota alpha-diversity will be determined from 16S rRNA sequencing","Between-treatment arm comparison on day 14 following 2-week intervention",{"measure":60,"description":57,"timeFrame":58},"alpha-Diversity (Shannon Index)",{"measure":62,"description":63,"timeFrame":58},"beta-Diversity (Bray-Curtis Dissimilarity)","Gut microbiota beta-diversity will be determined from 16S rRNA sequencing",{"measure":65,"description":63,"timeFrame":58},"beta-Diversity (UniFrac)",{"measure":67,"description":68,"timeFrame":12},"Toll-like Receptor-4 mRNA expression","qPCR measure of gene expression from Peripheral Blood Mononuclear Cells isolated from whole blood",{"measure":70,"description":68,"timeFrame":12},"TNF-alpha mRNA expression",{"measure":72,"description":68,"timeFrame":12},"Monocyte Chemoattract Protein-1 mRNA expression",{"measure":74,"description":68,"timeFrame":12},"Interleukin-6 mRNA expression",{"measure":76,"description":68,"timeFrame":12},"Interleukin-8 mRNA expression",{"measure":78,"description":68,"timeFrame":12},"Myeloid differentiation primary response 88 mRNA expression",{"allocation":80,"interventionModel":81,"interventionModelDescription":82,"primaryPurpose":83,"observationalModel":82,"timePerspective":82,"maskingInfo":84},"RANDOMIZED","CROSSOVER",null,"BASIC_SCIENCE",{"masking":85,"maskingDescription":82,"whoMasked":86},"TRIPLE",[87,88,89],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","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\u002Fm², 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.",[92,98],{"label":93,"type":94,"description":95,"interventionNames":96},"Inadequate Vitamin C Status","PLACEBO_COMPARATOR","Placebo + Low Vitamin C Diet",[97],"Dietary Supplement: Placebo + Low Vitamin C Diet",{"label":99,"type":100,"description":101,"interventionNames":102},"Adequate Vitamin C Status","EXPERIMENTAL","Vitamin C Supplement + Low Vitamin C Diet",[103],"Dietary Supplement: Vitamin C Supplement + Low Vitamin C Diet",[105,109],{"type":106,"name":101,"description":107,"armGroupLabels":108,"otherNames":82},"DIETARY_SUPPLEMENT","Participants will receive a vitamin C supplement (1000 mg\u002Fd) 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.",[99],{"type":106,"name":95,"description":110,"armGroupLabels":111,"otherNames":82},"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.",[93],[113],{"name":114,"affiliation":5,"role":115},"Richard Bruno, PhD, RD","PRINCIPAL_INVESTIGATOR",[117],{"name":118,"role":119,"phone":120,"phoneExt":82,"email":121},"Study Coordinator","CONTACT","614-292-4751","NutritionClinicalTrials@osu.edu",[123],{"facility":124,"status":125,"city":126,"state":127,"zip":128,"country":129,"countryCode":130,"cosmosGeoPoint":131,"geoPoint":136,"contacts":82},"The Ohio State University","RECRUITING","Columbus","Ohio","43210","United States","US",{"type":132,"coordinates":133},"Point",[134,135],-82.99879,39.96118,{"lat":135,"lon":134},{"type":115,"investigatorFullName":138,"investigatorTitle":139,"investigatorAffiliation":5,"oldNameTitle":82,"oldOrganization":82},"Richard Bruno","Principal Investigator","100604560","anti-inflammatory-activities-of-vitamin-c-supplementation-on-the-gut-barrier-function-in-adults-with-obesity-100604560",false,"NCT07151105","Anti-inflammatory Activities of Vitamin C Supplementation on the Gut Barrier Function in Adults With Obesity","Inclusion Criteria:\n\n* English speaking\n* Men and women between 18-50 years of age\n* BMI 30-40 kg\u002Fm²\n* Resting blood pressure \\\u003C140\u002F90 mm Hg\n* No use of multivitamin\u002Fvitamin C supplement within past 1-month\n* Non-vegetarian\u002Fnon-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\u002Fday\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).","ALL","18 Years","50 Years",{"count":150,"type":151},34,"ESTIMATED","INTERVENTIONAL",[154],"NA","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.",[99,93],"2026-08-29",{"date":159,"type":160},"2026-09-01","ACTUAL",{"date":162,"type":160},"2025-10-01",{"date":164,"type":151},"2028-12-30",{"name":5,"class":6},1]