[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06989164":3,"trial-entities:NCT06989164":107,"trial-summary:NCT06989164":112},{"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":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":36,"secondary_outcomes":44,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":15,"eligibility_criteria":62,"std_ages":82,"locations":85,"central_contacts":103,"overall_officials":104,"references":105,"see_also_links":106},"NCT06989164","80689","Post Prandial Individual Responses to Different Foods","Quantifying Differential Individual Responses to OGTT, Starchy Foods, and Mitigators and Its Association With Metabolic Subphenotypes","RECRUITING","2028-11-30","2025-11","2025-12-02","2025-10-01","Stanford University","OTHER",false,"This study aims to understand why people respond differently to the same foods, especially when it comes to changes in blood sugar after eating. A continuous glucose monitors (CGMs) will be used to observe how individuals respond to specific meals and drinks (e.g., Oral Glucose Tolerance Test, OGTT). By studying these patterns, the investigators hope to identify different types of metabolism and see if certain foods or food ingredients (like fiber, amino acids, or vinegar) can help control blood sugar better for specific groups. This research will help lay the groundwork for personalized dietary advice based on a person's unique biology.","Participants in the study will be provided with a continuous glucose monitor (CGM) and pre-measured cooked rice to test with different potential mitigators: fiber, acid, amino acid (e.g., leucine), whole protein, and exercise. Each of these conditions will be tested on a different day following strict instructions. For some of these tests, participants will be asked to collect a blood microsample and a saliva sample before and after eating the test meal. A stool sample will be collected at baseline.",[19,20,21],"PreDiabetes","Diabetes Mellitus, Type 2","Healthy",[],"INTERVENTIONAL","PREVENTION",[26],"NA",{"count":28,"type":29},100,"ESTIMATED",[31],{"type":14,"name":32,"description":33,"armGroupLabels":34},"Post prandial testing","A variety of foods, supplements, and short prescriptive exercise will be tested to see which one helps mitigate the rise is postprandial glucose after eating carbohydrate containing foods.",[35],"Diet Cycles",[37,41],{"measure":38,"description":39,"timeFrame":40},"Post prandial peak glucose levels","Delta glucose peak within 3 hours after consuming the standard meal - peak glucose value minus baseline glucose value at time 0 measured by CGM in mg\u002FdL.","3 hours",{"measure":42,"description":43,"timeFrame":40},"Post prandial glucose area under the curve (AUC)","AUC (\\>baseline) within three hours measured by CGM in mg\u002FdL during the 3 hours after each study meal.",[45,48,52,56],{"measure":46,"description":47,"timeFrame":40},"Glucose time to peak","The time in minutes from baseline to peak within 3 hours measured by CGM after each standardized meal.",{"measure":49,"description":50,"timeFrame":51},"Changes in personal post prandial metabolic states as measured in micro-sampling by targeted and untargeted metabolomics (LC-MS)","Dry blood samples will be collected by micro-sampling before and 1 hour after the standardized meals. Based on those samples, metabolomics (e.g., short-chain fatty acids, amino acids and other polar and nonpolar metabolites) will be extracted and quantified by liquid chromatography mass spectrometry (LC-MS). Both hydrophilic LC and reverse phase LC will be used. Q Exactive will be used for MS. Tandem MS will be collected for annotation. Relative quantification will be used, where the level of metabolites can be compared between samples. Chemical reference will be used for the absolute quantification of targeted metabolites.","1 hour",{"measure":53,"description":54,"timeFrame":55},"Individual microbiome composition","Microbiome will be defined by using metagenomics assay to baseline samples","Baseline",{"measure":57,"description":58,"timeFrame":51},"Changes in postprandial proteomic responses as measured in micro-sampling by Olink","Dry blood samples will be collected by micro-sampling frequently before and after the standardized meals. Based on those samples, proteomics will be quantified by proximity extension assay for the cardiometabolic panel. 96 proteins will be measured in the unit of normalized protein expression.","ALL","18 Years","80 Years",{"inclusion":63,"exclusion":68,"raw_text":81},[64,65,66,67],"BMI (body mass index) \\>19 kg\u002Fm2 but \\\u003C 45 kg\u002Fm2","HbA1c \\\u003C or equal to 7.0% while not on antihyperglycemic medications","Be willing to provide written informed consent for all study procedures.","Able to commute to Stanford campus for on-site visits",[69,70,71,72,73,74,75,76,77,78,79,80],"recent (\\\u003C6mos) CVD (cardiovascular disease) event","active malignancy","kidney\u002Fliver disease","pregnancy\u002Flactation","chronic inflammatory disease","eating disorder","bariatric surgery","history of acute pancreatitis","current use of antihyperglycemic, diabetogenic, or weight loss medications","heavy alcohol use","physical activity \\>2 hours\u002Fday","inability to come to Stanford CTRU (Clinical and Translational Research Unit) for metabolic testing","Inclusion Criteria:\n\n* BMI (body mass index) \\>19 kg\u002Fm2 but \\\u003C 45 kg\u002Fm2\n* HbA1c \\\u003C or equal to 7.0% while not on antihyperglycemic medications\n* Be willing to provide written informed consent for all study procedures.\n* Able to commute to Stanford campus for on-site visits\n\nExclusion Criteria:\n\n* recent (\\\u003C6mos) CVD (cardiovascular disease) event\n* active malignancy\n* kidney\u002Fliver disease\n* pregnancy\u002Flactation\n* chronic inflammatory disease\n* eating disorder\n* bariatric surgery\n* history of acute pancreatitis\n* current use of antihyperglycemic, diabetogenic, or weight loss medications\n* heavy alcohol use\n* physical activity \\>2 hours\u002Fday\n* inability to come to Stanford CTRU (Clinical and Translational Research Unit) for metabolic testing",[83,84],"ADULT","OLDER_ADULT",[86],{"facility":13,"status":8,"city":87,"state":88,"zip":89,"country":90,"contacts":91,"geoPoint":100},"Stanford","California","94304","United States",[92,97],{"name":93,"role":94,"phone":95,"email":96},"Sabrina Chun Johnston, MS, RD","CONTACT","(650) 725-0169","csjohn@stanford.edu",{"name":98,"role":99},"Dalia Perelman, MS, RD, CDE","SUB_INVESTIGATOR",{"lat":101,"lon":102},37.42411,-122.16608,[],[],[],[],{"nct_id":4,"conditions":108,"biomarkers":111},[21,109,110],"Prediabetes","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":113,"summary":114,"prompt_version":124},true,{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is an interventional study, meaning participants will receive specific interventions. It plans to enroll 100 participants.","completed","Understanding Individual Food Responses for Blood Sugar Control","This study is looking for people with prediabetes, type 2 diabetes, or healthy individuals aged 18-80 to understand why different people react differently to the same foods, especially regarding blood sugar levels after eating. You'll wear a continuous glucose monitor (CGM) and test various foods, supplements like fiber or amino acids, and short exercises to see how they affect your blood sugar. The goal is to find out if certain foods or ingredients can help manage blood sugar better for specific groups of people. To join, your BMI (body mass index) should be between 19 and 45, and your HbA1c (a measure of average blood sugar) should be 7.0% or less if you're not taking diabetes medication. The study aims to enroll 100 participants.","The primary endpoints, post-meal peak glucose levels and glucose area under the curve, will be measured at 3 hours after eating.",124,"You will be provided with a continuous glucose monitor (CGM) and pre-measured cooked rice to test with different mitigators like fiber, acid, amino acids, whole protein, and exercise on separate days. You may also be asked to collect blood microsamples, saliva samples, and a stool sample.","Not stated in the trial record.",[],"v2"]