[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06329544":3,"trial-entities:NCT06329544":100,"trial-summary:NCT06329544":104},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":44,"secondary_outcomes":52,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":15,"eligibility_criteria":56,"std_ages":75,"locations":77,"central_contacts":90,"overall_officials":96,"references":98,"see_also_links":99},"NCT06329544","STUDY-23-01572","High Fructose Diet, the Gut Microbiome, and Metabolic Health","The Effects of a High Fructose Diet on the Gut Microbiome and Metabolic Health: A Controlled Clinical Intervention Study","RECRUITING","2028-08-31","2025-11","2025-12-17","2024-10-08","Icahn School of Medicine at Mount Sinai","OTHER",true,"Americans commonly consume excess amounts of dietary fructose. Added fructose has been shown to have an adverse impact on metabolic health, including increased insulin resistance and type 2 diabetes (T2D) risk. However, the mechanisms that link dietary fructose and metabolic health are poorly understood. Malabsorption or incomplete metabolism of fructose in the small intestine is common in the population. Excess fructose reaches the colon where it may change the structure and function of the gut microbiome, alter bacterial metabolites and trigger inflammatory responses impacting T2D risk. To elucidate whether commonly consumed levels of dietary fructose influence metabolic outcomes through altering the gut microbiome, the research team will randomize 30 participants to a controlled cross-over dietary intervention, in which the participants will consume 12-day isocaloric, added fructose or glucose diets (25% of total calories) separated by a 10-day controlled diet washout period.\n\nThe research team aims to:\n\n1. Determine the relationships between high fructose consumption, the gut microbiome and metabolic risk.\n2. Characterize the causal role(s) that fructose-induced alterations to the gut microbiome have on metabolic risk using a germ-free mouse model.\n\nThe research team will measure 1) microbiota community structure and function via metagenomic sequencing of stool, 2) fecal metabolites via targeted and untargeted metabolomics, 3) anthropometrics, 4) insulin resistance, serum markers of T2D risk and inflammatory cytokines, 5) fecal microbial carbohydrate oxidation capacity and 6) liver fat via MRI elastography. The research team will use novel statistical approaches, including Distributed Lag Modeling, to understand the complex relationships between diet, the microbiome, metabolites and health outcomes.\n\nThe research team will then conduct controlled dietary interventions and fecal microbiome transplantation studies in germ-free mice. Donor fecal samples from human participants in both the glucose and fructose arms of the clinical intervention will be transplanted into germ-free and colonized mice to establish a causal relationship between fructose-induced changes to the gut microbiome, liver fat and metabolic and inflammatory changes known to increase risk for T2D.\n\nThe research team aims to comprehensively assess the structural and functional changes to the gut microbiome brought about by a high fructose diet. Determining the impact of excess fructose on the microbiome will help identify novel means by which fructose contributes to metabolic disease risk. In addition to identifying strategies to improve metabolic health in adults, data from this proposal could help inform targeted approaches to mitigate future disease risk in vulnerable populations that consume high levels of fructose, such as children.",null,[19,20,21],"MASLD","Type 2 Diabetes","Obesity",[23,19,21,24,25],"Microbiome","Fructose","Fatty Liver","INTERVENTIONAL","PREVENTION",[29],"NA",{"count":31,"type":32},30,"ESTIMATED",[34,40],{"type":35,"name":24,"description":36,"armGroupLabels":37},"DIETARY_SUPPLEMENT","12-day isocaloric weight-maintaining high fructose diet (25% total calories from added fructose)",[38,39],"Fructose Dietary then Glucose Dietary","Glucose Dietary then Fructose Dietary",{"type":35,"name":41,"description":42,"armGroupLabels":43},"glucose","12-day isocaloric weight-maintaining high glucose diet (25% total calories from added glucose)",[38,39],[45,49],{"measure":46,"description":47,"timeFrame":48},"Liver proton density fat fraction (PDFF)","Liver proton density fat fraction (PDFF) in %","year 3",{"measure":50,"description":51,"timeFrame":48},"Degree of fibrosis","Tissue shear stiffness will be measured in the right hepatic lobe \\[in kilopascals (kPa)\\] to assess the degree of fibrosis.",[],"ALL","25 Years","45 Years",{"inclusion":57,"exclusion":59,"raw_text":74},[58],"Participants must be determined to be a fructose malabsorber (screening visit) via hydrogen breath test.",[60,61,62,63,64,65,66,67,68,69,70,71,72,73],"Use of probiotic\u002Fprebiotic\u002Fsynbiotic supplements","Consumption of \\> 1 sugar sweetened beverage per day","Antibiotics within 3 months prior to enrollment or during intervention","Vegetarian, vegan or other restrictive dietary habits","Food allergy","Alcohol consumption in excess of 2 drink per day","Physician diagnosis of a major medical illness (including type 1 or type 2 diabetes) or eating disorder","Physical, mental, or cognitive handicaps that prevent participation","Chronic use of any medication that may affect body weight or composition, insulin resistance, or lipid profiles;","Current smoking (more than 1 cigarette in the past week) or use of other recreational drugs; e) restrictive dietary habits;","food allergy;","excess alcohol consumption;","recent use of pro-, pre- or Synbiotics of receipt of antibiotics within 3 months prior to enrollment or during the intervention;","consumption of greater than 1 sugar sweetened beverage per day prior to enrollment","Inclusion Criteria:\n\n* Participants must be determined to be a fructose malabsorber (screening visit) via hydrogen breath test.\n\nExclusion Criteria:\n\n* Use of probiotic\u002Fprebiotic\u002Fsynbiotic supplements\n* Consumption of \\> 1 sugar sweetened beverage per day\n* Antibiotics within 3 months prior to enrollment or during intervention\n* Vegetarian, vegan or other restrictive dietary habits\n* Food allergy\n* Alcohol consumption in excess of 2 drink per day\n\nThe following additional factors will be exclusion criteria:\n\n* Physician diagnosis of a major medical illness (including type 1 or type 2 diabetes) or eating disorder\n* Physical, mental, or cognitive handicaps that prevent participation\n* Chronic use of any medication that may affect body weight or composition, insulin resistance, or lipid profiles;\n* Current smoking (more than 1 cigarette in the past week) or use of other recreational drugs; e) restrictive dietary habits;\n* food allergy;\n* excess alcohol consumption;\n* recent use of pro-, pre- or Synbiotics of receipt of antibiotics within 3 months prior to enrollment or during the intervention;\n* consumption of greater than 1 sugar sweetened beverage per day prior to enrollment",[76],"ADULT",[78],{"facility":79,"status":8,"city":80,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":87},"Mount Sinai Morningside","New York","10025","United States",[84],{"name":85,"role":86},"Ryan Walker","PRINCIPAL_INVESTIGATOR",{"lat":88,"lon":89},40.71427,-74.00597,[91],{"name":92,"role":93,"phone":94,"email":95},"Ryan Walker, PhD","CONTACT","212-824-7088","ryan.walker@mssm.edu",[97],{"name":85,"affiliation":13,"role":86},[],[],{"nct_id":4,"conditions":101,"biomarkers":103},[102],"Hereditary Fructose Intolerance",[],{"nct_id":4,"found":15,"summary":105,"prompt_version":115},{"design":106,"status":107,"heading":108,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This is an interventional study with 30 planned participants. It compares a high fructose diet to a high glucose diet.","completed","High Fructose Diet, Gut Microbiome, and Metabolic Health Study","This study is looking at how a high fructose diet affects your gut microbiome (the bacteria in your intestines) and overall metabolic health, especially in people with MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), Type 2 Diabetes, or Obesity. You would follow either a high fructose diet or a high glucose diet for 12 days. Researchers want to understand how fructose impacts your body and potentially contributes to conditions like Type 2 Diabetes. To join, you must be a fructose malabsorber, meaning your body doesn't fully absorb fructose. The study aims to measure changes in liver fat (Liver proton density fat fraction) and liver scarring (Degree of fibrosis) after three years. The current recruitment status is unclear.","Participants will be followed for three years to measure liver fat and fibrosis.",116,"You would follow a specific diet (either high fructose or high glucose) for 12 days. Your liver fat and scarring would be measured at year 3.","Not stated in the trial record.",[24,41],"v2"]