[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06902480":3,"trial-entities:NCT06902480":123,"trial-summary:NCT06902480":127},{"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":21,"study_type":22,"primary_purpose":14,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":45,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":15,"eligibility_criteria":70,"std_ages":95,"locations":98,"central_contacts":116,"overall_officials":119,"references":121,"see_also_links":122},"NCT06902480","2024-1661","Dairy Choline Bioavailability","Assessing Choline Bioavailability and Metabolism From a New Dairy Ingredient for Post-Menopausal Women","NOT_YET_RECRUITING","2027-12","2026-08","2026-08-28","2026-09","University of Wisconsin, Madison","OTHER",true,"The goal of this clinical trial is to find out if dairy is a good source of choline compared to eggs. The main questions it aims to answer are:\n\n* How the body uses choline; and,\n* What effect WPPC has on choline metabolism.\n\nResearchers will compare Whey Protein Phospholipid Concentrate (WPPC) to whole egg powder to see if WPPC is as effective as eggs.\n\nParticipants will drink a chocolate-flavored smoothie mixed with either WPPC or whole egg powder.","This study is intended to evaluate the bioavailability and metabolism of choline in WPPC compared to the most commonly -used food for bioavailable choline, whole egg. The intent of the evaluation is to improve the knowledge of how WPPC contributes to the nutritional needs and health of postmenopausal women.",[19,20],"Post-menopausal Women","Post-menopausal Status",[],"INTERVENTIONAL",[24],"NA",{"count":26,"type":27},24,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DIETARY_SUPPLEMENT","WPPC","A chocolate-flavored smoothie with WPPC added",[34],"Whey Protein Phospholipid Concentrate (WPPC)",{"type":30,"name":36,"description":37,"armGroupLabels":38},"Whole egg powder","A chocolate-flavored smoothie with whole egg powder added",[39],"Pasteurized whole egg powder",[41],{"measure":42,"description":43,"timeFrame":44},"Change in circulating choline","Circulating choline will be measured by UHPLC-HRMS\u002FMS","Baseline to 10 days",[46,49,52,55,58,61,64],{"measure":47,"description":48,"timeFrame":44},"Change in co-factors in circulating choline","Co-factors in the circulation will be measured by ultrahigh performance liquid chromatography coupled with high resolution tandem mass spectrometry (UHPLC-HRMS\u002FMS).",{"measure":50,"description":51,"timeFrame":44},"Change in high-sensitivity C-reactive protein (hs-CRP)","Safety biomarker Hs-CRP will be measured using immunoturbidimetry.",{"measure":53,"description":54,"timeFrame":44},"Change in circulating choline metabolites","Metabolites will be measured by UHPLC-HRMS\u002FMS.",{"measure":56,"description":57,"timeFrame":44},"Change in 8-hydroxydeoxyguanosine","The safety biomarker 8-hydroxydeoxyguanosine (8-OHDG) will be measured using enzyme-linked immunosorbent assay (ELISA).",{"measure":59,"description":60,"timeFrame":44},"Change in aspartate transaminase","Aspartate transaminase (AST) will be measured using kinetic methods.",{"measure":62,"description":63,"timeFrame":44},"Change in alanine transaminase (ALT)","Alanine transaminase will be measured using kinetic methods.",{"measure":65,"description":66,"timeFrame":44},"Change in creatinine","Creatinine will be measured using kinetic methods","FEMALE","51 Years","70 Years",{"inclusion":71,"exclusion":84,"raw_text":94},[72,73,74,75,76,77,78,79,80,81,82,83],"Ages between 51 and 70","Is currently post-menopausal (Post-menopausal is a term used to describe the time in a woman's life after she has gone through menopause. This usually happens between the ages of 45 and 55. Menopause is when a woman's menstrual periods stop permanently (at least 12 months))","Not allergic to the intervention foods and allergens that are related to the production of intervention foods (e.g. dairy products, egg, fish, peanut, shellfish, soy, tree nuts, wheat, crustaceans, gluten, mollusks, mustard, sesame seeds.)","Had stable body weight (± 5%) for the past 6 months","Free from cancer","Did not have weight loss surgery, colon surgery","Do not have chronic kidney diseases","Do not have malabsorption towards fat and dairy products","Willing to complete health surveys","Willing to complete two 4-day food diaries","Willing to consume the intervention smoothies","Willing to provide blood, urine, fecal samples at baseline and after 10 days of intervention",[85,86,87,88,89,90,91,92,93],"On weight loss\u002Fweight gain diets","Diagnosed with fat malabsorption","Undergoing weight loss surgery","Diagnosed with chronic kidney diseases","Allergic to the intervention foods and allergens that are related to the production of intervention foods (e.g. dairy products, egg, chocolate, fish, peanut, shellfish, soy, tree nuts, wheat, crustaceans, gluten, mollusks, mustard, sesame seeds, banana, strawberry, raspberry, blackberry, blueberry.)","Regularly using antibiotics or probiotics or prebiotics","Regularly using weight-loss drugs (GLP-1, Orlistat, Cetilistat, etc.)","Regularly using laxatives","Unable to avoid strenuous exercise during the study (\\>4 h vigorous exercise per day)","Inclusion Criteria:\n\n* Ages between 51 and 70\n* Is currently post-menopausal (Post-menopausal is a term used to describe the time in a woman's life after she has gone through menopause. This usually happens between the ages of 45 and 55. Menopause is when a woman's menstrual periods stop permanently (at least 12 months))\n* Not allergic to the intervention foods and allergens that are related to the production of intervention foods (e.g. dairy products, egg, fish, peanut, shellfish, soy, tree nuts, wheat, crustaceans, gluten, mollusks, mustard, sesame seeds.)\n* Had stable body weight (± 5%) for the past 6 months\n* Free from cancer\n* Did not have weight loss surgery, colon surgery\n* Do not have chronic kidney diseases\n* Do not have malabsorption towards fat and dairy products\n* Willing to complete health surveys\n* Willing to complete two 4-day food diaries\n* Willing to consume the intervention smoothies\n* Willing to provide blood, urine, fecal samples at baseline and after 10 days of intervention\n\nExclusion Criteria:\n\n* On weight loss\u002Fweight gain diets\n* Diagnosed with fat malabsorption\n* Undergoing weight loss surgery\n* Diagnosed with chronic kidney diseases\n* Allergic to the intervention foods and allergens that are related to the production of intervention foods (e.g. dairy products, egg, chocolate, fish, peanut, shellfish, soy, tree nuts, wheat, crustaceans, gluten, mollusks, mustard, sesame seeds, banana, strawberry, raspberry, blackberry, blueberry.)\n* Regularly using antibiotics or probiotics or prebiotics\n* Regularly using weight-loss drugs (GLP-1, Orlistat, Cetilistat, etc.)\n* Regularly using laxatives\n* Unable to avoid strenuous exercise during the study (\\>4 h vigorous exercise per day)",[96,97],"ADULT","OLDER_ADULT",[99],{"facility":100,"city":101,"state":102,"zip":103,"country":104,"contacts":105,"geoPoint":113},"University of Wisconsin - Madison","Madison","Wisconsin","53705","United States",[106,110],{"name":107,"role":108,"email":109},"Kevin Shih","CONTACT","sshih22@wisc.edu",{"name":111,"role":112},"Bradley Bolling, PhD","PRINCIPAL_INVESTIGATOR",{"lat":114,"lon":115},43.07305,-89.40123,[117],{"name":107,"role":108,"phone":118,"email":109},"919-338-9453",[120],{"name":111,"affiliation":13,"role":112},[],[],{"nct_id":4,"conditions":124,"biomarkers":126},[125],"Postmenopausal",[],{"nct_id":4,"found":15,"summary":128,"prompt_version":138},{"design":129,"status":130,"heading":131,"summary":132,"follow_up":133,"word_count":134,"commitments":135,"compensation":136,"drugs_mentioned":137},"This is an interventional study planning to enroll 24 post-menopausal women aged 51-70.","completed","Dairy Choline Bioavailability in Post-menopausal Women","This study is looking at how well your body uses choline from dairy compared to eggs. Researchers want to understand how the body processes choline and what effect Whey Protein Phospholipid Concentrate (WPPC) has on this process. They will compare WPPC to whole egg powder to see if WPPC is just as effective as eggs in providing choline. You would drink a chocolate-flavored drink containing either WPPC or whole egg powder. This study is for women aged 51 to 70 who are post-menopausal (meaning your menstrual periods have stopped permanently for at least 12 months). The main goal is to measure changes in choline levels in your blood over 10 days. The current recruitment status is unclear, and the study plans to enroll 24 participants.","Participants will be followed for 10 days after the intervention.",125,"Participants will drink a chocolate-flavored drink with either WPPC or whole egg powder. Choline levels will be measured from baseline to 10 days.","Not stated in the trial record.",[31,36],"v2"]