[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05236374":3,"trial-entities:NCT05236374":125,"trial-summary:NCT05236374":131},{"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":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":46,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":92,"locations":95,"central_contacts":111,"overall_officials":118,"references":123,"see_also_links":124},"NCT05236374","1806393","Effects of Daily Beef Intake, as a Component of a Heart-Healthy Diet on Cellular Zinc","Effects of Daily Beef Intake, as a Component of a Heart-Healthy Diet, on Cellular Zinc Status and Vascular Function in Older Adults","RECRUITING","2026-12-31","2026-02","2026-02-09","2022-10-01","University of California, Davis","OTHER",false,"The objective of the current study is to test the overarching hypothesis that the beef nutritive matrix is uniquely suited to direct dietary zinc to cellular compartments for improved metabolic function, leading to a greater effect on health outcomes. Specifically, whether beef, as a component of a healthy meal, will promote the absorption of zinc into cells, where the zinc will have greater effects on zinc-dependent metabolic processes supporting cardiovascular health. To maximize the observability of these beef-related effects, individuals who are 55- to 70-year-old who generally have a higher risk of zinc deficiency and cardiovascular disease will be enrolled.","This study will examine whether daily beef intake will promote the absorption of dietary zinc into cells, leading to improved cellular zinc status and microvascular function. The study design will be a crossover comparison of a mixed diet including green leafy vegetables, fruits, whole grains, seeds, and nuts; with beef versus non-meat sources of additional protein and zinc, over two 4-week metabolic study periods.\n\nOutcomes will include cellular zinc status determined by erythrocyte zinc tracer exchange (primary), and microvascular function expressed as reactive hyperemia index (RHI). Previous studies have demonstrated that zinc tracer exchange with red blood cells (RBC) is highly sensitive to changes in zinc nutriture. Thus, cellular zinc status will be determined using a novel and cost-effective adaptation of this approach, modeling zinc tracer exchange with freshly-sampled RBC. As intracellular zinc can regulate vascular tone, microvascular function will be measured, using digital peripheral tonometry, will be used as a functional index of both cellular zinc status and vascular health.",[19,20,21,22],"Zinc Deficiency","Inflammation","Metabolic Diseases","Vascular Diseases",[],"INTERVENTIONAL","PREVENTION",[27],"NA",{"count":29,"type":30},20,"ESTIMATED",[32],{"type":14,"name":33,"description":34,"armGroupLabels":35},"Beef protein","Animal protein source",[36,37],"Animal Protein","Beef Protein",[39,43],{"measure":40,"description":41,"timeFrame":42},"microvascular function","microvascular function as measured by digital tonometry (EndoPAT2000)","4 weeks",{"measure":44,"description":45,"timeFrame":42},"intracellular zinc status","intracellular zinc status determined by erythrocyte zinc tracer exchange",[47,50,53],{"measure":48,"description":49,"timeFrame":42},"plasma lipids","Circulating level of total cholesterol, triglycerides, HDL cholesterol, non-HDL cholesterol, with LDL cholesterol (calculated)",{"measure":51,"description":52,"timeFrame":42},"plasma fatty acids","Circulating levels of non-esterified fatty acids",{"measure":54,"description":55,"timeFrame":42},"plasma oxylipins","enzyme and non-enzyme derived non-esterified fatty acid metabolites","ALL","55 Years","70 Years",true,{"inclusion":61,"exclusion":68,"raw_text":91},[62,63,64,65,66,67],"Male or postmenopausal female 55-70 years of age","Women: lack of menses for at least two years.","Subject is willing and able to comply with the study protocols.","Subject is willing to participate in all study procedures","Self-reported stable dose of prescribed medications for a minimum of 6 months","BMI 18.5 - 29.9 kg\u002Fm2",[69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90],"Self-reported use of daily anticoagulation agents including aspirin, NSAIDs","Prescribed metaformin, statins or medications known to interfere with zinc, protein, or lipid metabolism","Vegan, Vegetarians, food faddists or those consuming a non-traditional diet (e.g. Adkins, Keto, Paleo, etc.)","Fruit consumption ≥ 3 cups\u002Fday","Regular consumption of strawberries (2-3 servings\u002Fweek)","Vegetable consumption ≥ 4 cups\u002Fday","Coffee\u002Ftea ≥ 3 cups\u002Fday","Dark chocolate ≥ 3 oz\u002Fday","Alcohol intake greater than 2 drinks in a day for men, or 1 drink in a day for women.","Self-reported restriction of physical activity due to a chronic health condition","Self-reported chronic\u002Froutine high intensity exercise","Self-reported diabetes","Blood pressure ≥ 140\u002F90 mm Hg","Self-reported renal or liver disease","Self-reported heart disease, which includes cardiovascular events and stroke","Peripheral artery disease Raynaud's syndrome or disease","Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT","Self-reported cancer within past 5 years","Self-reported malabsorption","Unwillingness to stop any supplement use six weeks prior to study initiation, including multivitamin\u002Fmineral, powders, herbal, plant or botanical, pro- and prebiotics, and oil supplements.","Smoking, vaping, cannabis use","Current enrollee in a clinical research study.","Inclusion Criteria:\n\n* Male or postmenopausal female 55-70 years of age\n* Women: lack of menses for at least two years.\n* Subject is willing and able to comply with the study protocols.\n* Subject is willing to participate in all study procedures\n* Self-reported stable dose of prescribed medications for a minimum of 6 months\n* BMI 18.5 - 29.9 kg\u002Fm2\n\nExclusion Criteria:\n\n* Self-reported use of daily anticoagulation agents including aspirin, NSAIDs\n* Prescribed metaformin, statins or medications known to interfere with zinc, protein, or lipid metabolism\n* Vegan, Vegetarians, food faddists or those consuming a non-traditional diet (e.g. Adkins, Keto, Paleo, etc.)\n* Fruit consumption ≥ 3 cups\u002Fday\n* Regular consumption of strawberries (2-3 servings\u002Fweek)\n* Vegetable consumption ≥ 4 cups\u002Fday\n* Coffee\u002Ftea ≥ 3 cups\u002Fday\n* Dark chocolate ≥ 3 oz\u002Fday\n* Alcohol intake greater than 2 drinks in a day for men, or 1 drink in a day for women.\n* Self-reported restriction of physical activity due to a chronic health condition\n* Self-reported chronic\u002Froutine high intensity exercise\n* Self-reported diabetes\n* Blood pressure ≥ 140\u002F90 mm Hg\n* Self-reported renal or liver disease\n* Self-reported heart disease, which includes cardiovascular events and stroke\n* Peripheral artery disease Raynaud's syndrome or disease\n* Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT\n* Self-reported cancer within past 5 years\n* Self-reported malabsorption\n* Unwillingness to stop any supplement use six weeks prior to study initiation, including multivitamin\u002Fmineral, powders, herbal, plant or botanical, pro- and prebiotics, and oil supplements.\n* Smoking, vaping, cannabis use\n* Current enrollee in a clinical research study.",[93,94],"ADULT","OLDER_ADULT",[96],{"facility":97,"status":8,"city":98,"state":99,"zip":100,"country":101,"contacts":102,"geoPoint":108},"University of California, Davis; Department of Nutrition","Davis","California","95616","United States",[103],{"name":104,"role":105,"phone":106,"email":107},"Roberta Holt, PhD","CONTACT","530-752-4950","rrholt@ucdavis.edu",{"lat":109,"lon":110},38.54491,-121.74052,[112,115],{"name":113,"role":105,"phone":114,"email":107},"Roberta R Holt, PhD","15304005952",{"name":116,"role":105,"email":117},"Andrew Hall, PhD","aghall@ucdavis.edu",[119],{"name":120,"affiliation":121,"role":122},"Carl L Keen, PhD","Distinguished Professor Emeritus of Nutrition","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":126,"biomarkers":130},[20,127,128,129],"Metabolic Disorder","Vascular Disorder","Zinc Deficiency Disorder",[],{"nct_id":4,"found":59,"summary":132,"prompt_version":142},{"design":133,"status":134,"heading":135,"summary":136,"follow_up":137,"word_count":138,"commitments":139,"compensation":140,"drugs_mentioned":141},"This is a crossover study comparing a beef-inclusive diet with a non-meat protein diet over two 4-week periods. It plans to enroll 20 participants.","completed","Daily Beef Intake and Cellular Zinc Study","This study is looking at how eating beef daily, as part of a heart-healthy diet, affects the amount of zinc inside your cells. Researchers want to see if beef helps your body absorb zinc better, which could improve your metabolism and heart health. They will compare a diet with beef to a diet with other protein sources. You might be able to join if you are a man or postmenopausal woman between 55 and 70 years old, have a BMI between 18.5 and 29, and are willing to follow the study plan. The study will measure how well your small blood vessels work (microvascular function) and your cellular zinc levels after 4 weeks to see if the beef diet has a positive effect. The study aims to enroll 20 participants.","The primary endpoints for microvascular function and intracellular zinc status are measured at 4 weeks.",130,"You would participate in two 4-week study periods, following specific diets and undergoing measurements for microvascular function and cellular zinc status.","Not stated in the trial record.",[],"v2"]