[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658950":3},{"organization":4,"outcomesModule":7,"designInfo":115,"detailedDescription":128,"studyPopulation":120,"armGroups":129,"interventions":147,"overallOfficials":120,"centralContacts":157,"locations":163,"responsibleParty":184,"collaborators":120,"id":186,"slug":187,"hasResults":188,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":120,"eligibilityCriteria":192,"healthyVolunteers":193,"sex":194,"minAge":195,"maxAge":196,"enrollmentInfo":197,"targetDuration":120,"studyType":200,"phases":201,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":218,"whyStopped":120,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":228},{"fullName":5,"class":6},"Bovita Labs, LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":106},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Gastrointestinal Function Assessed by the PROMIS Gastrointestinal Combined Short Form","Gastrointestinal function will be assessed using the PROMIS Gastrointestinal Combined Short Form (PROMIS-GI-SF), a self-administered questionnaire assessing dimensions of gastrointestinal status and function. The primary endpoint is the change in gastrointestinal function from baseline to the end of the 16-week supplementation period.","Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20",[14,17,20,24,27,31,34,37,40,43,46,49,52,55,58,61,64,67,70,73,76,79,82,85,88,91,94,97,100,103],{"measure":15,"description":16,"timeFrame":12},"Change in Digestive Comfort and Gut Health","Participants will rate their digestive comfort and gut health by answering the question, \"Overall, how would you rate for digestive health and gut comfort today?\" Answers are provided using a visual analog scale ranging from 0 (Very Poor) to 100 (Excellent).",{"measure":18,"description":19,"timeFrame":12},"Change in Perceived Immune System Strength and Resilience","Participants will rate their immune strength and resilience by answering the question, \"How would you rate the overall strength and resilience of your immune system over the past 7 days?\" Answers are provided using a visual analog scale ranging from 0 (Very Poor) to 100 (Excellent).",{"measure":21,"description":22,"timeFrame":23},"Change in Participant-Reported Energy Levels","Participants will rate their energy levels by answering the question, \"In the past 7 days, how would you rate your overall energy levels throughout the day?\" Answers are provided on a Likert scale ranging from 1 (Very low energy) to 7 (Very high energy).","Week 0, Week 2, Week 4, Week 8, Week 12, Week 16",{"measure":25,"description":26,"timeFrame":23},"Change in Participant-Reported Sleep Quality","Participants will rate their sleep quality by answering the question, \"In the past 7 days, how would you rate the quality of your sleep overall?\" Answers are provided on a Likert scale ranging from 1 (Very poor sleep) to 7 (Excellent sleep).",{"measure":28,"description":29,"timeFrame":30},"Change in total cholesterol","At-home dried blood spot samples will be collected to evaluate concentrations of total cholesterol. Units of measure are in milligrams per deciliter.","Week 0 and Week 16",{"measure":32,"description":33,"timeFrame":30},"Evaluation of baseline and change in microbial diversity","Participant-collected stool samples will be analyzed to evaluate changes in microbial diversity. Evaluations are made based on detected bacterial taxa and strains. An index (unitless) is provided.",{"measure":35,"description":36,"timeFrame":30},"Change in Hair Strength","Participants will rate their hair strength by answering the question, \"My hair feels more nourished and less dry or brittle? Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.",{"measure":38,"description":39,"timeFrame":30},"Change in Skin Hydration","Participants will rate their skin hydration by answering the question, \"My skin feels hydrated?\" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.",{"measure":41,"description":42,"timeFrame":30},"Change in HDL cholesterol","At-home dried blood spot samples will be collected to evaluate concentrations of high-density lipoprotein (HDL) cholesterol. Units of measure are in milligrams per deciliter.",{"measure":44,"description":45,"timeFrame":30},"Change in LDL cholesterol","At-home dried blood spot samples will be collected to evaluate concentrations of low-density lipoprotein (LDL) cholesterol. Units of measure are in milligrams per deciliter.",{"measure":47,"description":48,"timeFrame":30},"Change in high-sensitivity C-reactive protein","At-home dried blood spot samples will be collected to evaluate concentrations of high-sensitivity C-reactive protein (CRP). Units of measure are in milligrams per liter.",{"measure":50,"description":51,"timeFrame":30},"Change in hemoglobin A1c (HbA1c)","At-home dried blood spot samples will be collected to evaluate levels of hemoglobin A1c (HbA1c). Units of measure are in % of total hemoglobin.",{"measure":53,"description":54,"timeFrame":30},"Change in gamma-glutamyl transferase (GGT)","At-home dried blood spot samples will be collected to evaluate concentrations of gamma-glutamyl transferase (GGT). Units of measure are in units per liter.",{"measure":56,"description":57,"timeFrame":30},"Change in fasting glucose","At-home dried blood spot samples will be collected to evaluate fasting concentrations of glucose. Units of measure are in milligrams per deciliter.",{"measure":59,"description":60,"timeFrame":30},"Evaluation of baseline and change in microbial abundance","Participant-collected stool samples will be analyzed to evaluate changes in microbial abundance. Evaluations are made based on detected bacterial taxa and strains. A percentage or proportion of relative abundance of total bacterial sequences will be quantified.",{"measure":62,"description":63,"timeFrame":30},"Evaluation of baseline and change in microbial richness","Participant-collected stool samples will be analyzed to evaluate changes in microbial richness. Evaluations are made based on detected bacterial taxa and strains. An index (unitless) is provided.",{"measure":65,"description":66,"timeFrame":30},"Evaluation of baseline and change in microbial evenness","Participant-collected stool samples will be analyzed to evaluate changes in microbial evenness. Evaluations are made based on detected bacterial taxa and strains. An index (unitless) is provided.",{"measure":68,"description":69,"timeFrame":30},"Evaluation of baseline and change in the amount of short-chain fatty acid producers","Participant-collected stool samples will be analyzed to evaluate changes in bacterial taxa that are known fatty acid chain producers. General relative abunance (%) will be provided.",{"measure":71,"description":72,"timeFrame":30},"Change in the ratio of triglycerides to HDL cholesterol ratio","At-home dried blood spot samples will be collected to evaluate changs in the ratio of triglycerides to HDL choelsterol. This measurement is a unitless ratio.",{"measure":74,"description":75,"timeFrame":30},"Change in triglycerides","At-home dried blood spot samples will be collected to evaluate concentrations of triglycerides. Units of measure are in milligrams per deciliter.",{"measure":77,"description":78,"timeFrame":30},"Modified hair pull test","Participants will complete a modified hair pull test. The number of hair strands yielded from the hair pull test will be counted and used for assessment.",{"measure":80,"description":81,"timeFrame":30},"Change in Hair Quality","Participants will rate their hair quality by answering the question, \"I have noticed an improvement in overall hair quality?\" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.",{"measure":83,"description":84,"timeFrame":30},"Change in Hair Health","Participants will rate their hair health by answering the question, \"I have noticed an improvement in the appearance of hair health?\" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.",{"measure":86,"description":87,"timeFrame":30},"Change in Hair Texture","Participants will rate their hair texture by answering the question, \"I have noticed an improvement in hair texture?\" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.",{"measure":89,"description":90,"timeFrame":30},"Change in Hair Volume","Participants will rate their hair volume by answering the question, \"I have noticed an improvement in hair volume?\" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.",{"measure":92,"description":93,"timeFrame":30},"Change in Hair Shedding","Participants will rate their hair shedding by answering the question, \"I have noticed an improvement in hair shedding?\" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.",{"measure":95,"description":96,"timeFrame":30},"Change in Clearness of Skin","Participants will rate their skin clearness by answering the question, \"My skin appears clear?\" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.",{"measure":98,"description":99,"timeFrame":30},"Change in Overall Skin Health","Participants will rate their overall skin health by answering the question, \"I have noticed an improvement in my overall skin health?\" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.",{"measure":101,"description":102,"timeFrame":30},"Change in Dry Skin","Participants will rate their overall skin dryness by answering the question, \"I am experiencing dry skin?\" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.",{"measure":104,"description":105,"timeFrame":30},"Change in Happiness with Skin","Participants will rate their overall happiness with their skin by answering the question, \"I am happy with my skin?\" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.",[107,111],{"measure":108,"description":109,"timeFrame":110},"Daily Step Count","Step count data will be passively collected, where available, from compatible wearable devices or connected Apple Health\u002FGoogle Fit data sources.","Baseline through Week 20.",{"measure":112,"description":113,"timeFrame":114},"Change in Wearable-Derived Heart Rate Variability","Heart rate variability will be passively collected from compatible wearable devices or connected health-data sources where available","Baseline through Week 20",{"allocation":116,"interventionModel":117,"interventionModelDescription":118,"primaryPurpose":119,"observationalModel":120,"timePerspective":120,"maskingInfo":121},"RANDOMIZED","PARALLEL","Randomized, double-blind, placebo-controlled, parallel groups","OTHER",null,{"masking":122,"maskingDescription":123,"whoMasked":124},"TRIPLE","Participants are randomized to receive one of two doses of bovine colostrum or a matched placebo. The study is described in the protocol as double-blind. Blinding and randomization will be facilitated through the Alethios platform.",[125,126,127],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","This randomized, double-blind, placebo-controlled, fully decentralized study will evaluate the effects of two daily doses of bovine colostrum compared with placebo on gastrointestinal health and related health outcomes in adults. Aadults aged 30 to 60 years will be enrolled and randomized in a 1:1:1 ratio to one of three study groups: one of two bovine colostrum doses or a matched placebo. The study is designed to obtain approximately 105 participants who complete the protocol.\n\nThe study will be conducted entirely remotely, with no required in-person study visits. Following electronic screening and informed consent, eligible participants will complete baseline assessments through the Alethios digital research platform. Participants will then consume their assigned study product once daily with food for 16 weeks. The supplementation period will be followed by a 4-week non-supplementation period to evaluate outcomes following discontinuation of the study product. Total participant involvement is expected to be approximately 20 to 21 weeks.\n\nThe primary objective is to evaluate changes in participant-reported gastrointestinal function during the 16-week supplementation period. Gastrointestinal function will be assessed using the PROMIS Gastrointestinal (GI) Combined Short Form, with the primary endpoint defined as the change from baseline to Week 16.\n\nSecondary outcomes will evaluate digestive comfort and gut health, perceived immune system strength and resilience, energy levels, sleep quality, metabolic health, gut microbiome status and function, and hair and skin health. Exploratory outcomes will include physical activity and heart rate variability derived from compatible wearable devices or connected health-data sources.\n\nParticipant-reported assessments will be completed at scheduled intervals throughout the study, including baseline and Weeks 2, 4, 8, 12, 16, and\u002For 20, depending on the specific outcome. Digestive comfort\u002Fgut health and immune resilience assessments will continue through the 4-week post-supplementation period to characterize changes following discontinuation of the study product.\n\nParticipants will also complete at-home biospecimen collections. Dried blood spot samples will be collected to assess metabolic health, including high-sensitivity C-reactive protein (hsCRP), and stool samples will be collected for assessment of gut microbiome status and function. These biospecimens will be collected at baseline and Week 16 and returned to designated analytical laboratories using provided collection and shipping materials. Participants will additionally provide standardized photographs for assessment of hair and skin health.\n\nStudy product adherence will be monitored electronically through the study platform. Participants will record study product intake during the supplementation period and will be able to report adverse events or other health concerns throughout the study. Where available, compatible wearable devices or connected Apple Health\u002FGoogle Fit data sources will be used to passively collect physical activity and heart rate variability data.\n\nThe primary analysis will compare longitudinal changes in gastrointestinal function among the three randomized groups. A linear mixed-effects model will be used with supplementation group and time as fixed effects and participant as a random effect. Secondary and exploratory outcomes will be analyzed using statistical methods appropriate to the distribution and longitudinal structure of each outcome.\n\nThe study is intended to characterize the effects of daily bovine colostrum supplementation on gastrointestinal function and related consumer health outcomes and to explore whether changes in gastrointestinal health are accompanied by changes in digestive comfort, immune resilience, energy, sleep, metabolic markers, gut microbiome characteristics, hair and skin health, physical activity, and heart rate variability.",[130,136,141],{"label":131,"type":132,"description":133,"interventionNames":134},"Lower Dose Bovine Colostrum","EXPERIMENTAL","Participants randomized to this group will consume the protocol-defined lower dose of bovine colostrum once daily with food for 16 weeks, followed by a 4-week non-supplementation period.",[135],"Dietary Supplement: Bovine Colostrum - Lower Dose",{"label":137,"type":132,"description":138,"interventionNames":139},"Higher-Dose Bovine Colostrum","Participants randomized to this group will consume the protocol-defined higher dose of bovine colostrum once daily with food for 16 weeks, followed by a 4-week non-supplementation period.",[140],"Dietary Supplement: Bovine Colostrum - Higher Dose",{"label":142,"type":143,"description":144,"interventionNames":145},"Placebo","PLACEBO_COMPARATOR","Participants randomized to this group will consume a matched placebo once daily with food for 16 weeks, followed by a 4-week non-supplementation period.",[146],"Dietary Supplement: Placebo",[148,152,155],{"type":149,"name":150,"description":133,"armGroupLabels":151,"otherNames":120},"DIETARY_SUPPLEMENT","Bovine Colostrum - Lower Dose",[131],{"type":149,"name":153,"description":138,"armGroupLabels":154,"otherNames":120},"Bovine Colostrum - Higher Dose",[137],{"type":149,"name":142,"description":144,"armGroupLabels":156,"otherNames":120},[142],[158],{"name":159,"role":160,"phone":161,"phoneExt":120,"email":162},"Chad Kerksick, PhD","CONTACT","650-206-8006","chad.kerksick@gmail.com",[164],{"facility":165,"status":120,"city":166,"state":167,"zip":168,"country":169,"countryCode":170,"cosmosGeoPoint":171,"geoPoint":176,"contacts":177},"Alethios, Inc.","San Francisco","California","94109","United States","US",{"type":172,"coordinates":173},"Point",[174,175],-122.41942,37.77493,{"lat":175,"lon":174},[178,181],{"name":179,"role":160,"phone":161,"phoneExt":120,"email":180},"Zeenia Framroze, MA","zeenia@alethios.com",{"name":182,"role":160,"phone":161,"phoneExt":120,"email":183},"Zoe Benham, BS","zoe@alethios.com",{"type":185,"investigatorFullName":120,"investigatorTitle":120,"investigatorAffiliation":120,"oldNameTitle":120,"oldOrganization":120},"SPONSOR","100658950","colostrum-and-gut-health-100658950",false,"NCT07856979","Colostrum and Gut Health","A Randomized Controlled Trial to Examine the Impact of Two Colostrum Doses on Gut Health","Inclusion Criteria:\n\n* Adults aged 30 to 60 years at the time of enrollment.\n* Self-reported suboptimal digestive function (e.g., bloating, irregular bowel habits, discomfort) and\u002For suboptimal immune function (e.g., frequent colds, low energy) during the previous 4 weeks.\n* Willing and able to consume a powdered supplement (3-6 g) mixed in liquid once daily.\n* Own a compatible iOS or Android smartphone with internet access.\n* Willing to connect a compatible wearable device (Apple Watch or Oura Ring) or Apple Health\u002FGoogle Fit data source for passive data collection.\n* Complete at least 30 minutes of physical activity or exercise most days of the week.\n* Able to provide informed consent and comply with the study protocol for 20 weeks.\n* Able to read and understand English.\n* Willing to provide informed consent electronically.\n\nExclusion Criteria:\n\n* Diagnosis of inflammatory bowel disease, Crohn's disease, ulcerative colitis, or other malabsorptive gastrointestinal disease or condition.\n* Diagnosis of celiac disease or known severe allergy to dairy-derived or bovine colostrum products.\n* Currently pregnant, breastfeeding, or planning pregnancy during the study period.\n* Current or within the previous 30 days use of immunosuppressive medications, systemic corticosteroids, or biologic agents.\n* Use of bovine colostrum or colostrum-containing supplements within the previous 30 days.\n* Regular use of probiotic or prebiotic supplements within 14 days of enrollment. Does not participate in at least 30 minutes of physical activity or exercise most days of the week.\n* Major gastrointestinal surgery within the previous 12 months.\n* Autoimmune condition requiring immunomodulatory treatment.\n* Participation in another interventional clinical study within 30 days of enrollment.\n* Body mass index greater than 35.0 kg\u002Fm².\n* Known or severe lactose intolerance or milk protein allergy.",true,"ALL","30 Years","60 Years",{"count":198,"type":199},140,"ESTIMATED","INTERVENTIONAL",[202],"NA","The primary objective of this study is to evaluate changes in participant-reported gastrointestinal function over a 16-week intervention period and a 4-week non-supplementation period (20 weeks total) following daily consumption of two different doses of colostrum in comparison to a placebo.\n\nSecondary objectives include evaluation of digestive comfort, immune resilience, energy levels, sleep quality, hsCRP, metabolic panel, microbiome status and function, and hair and skin health.\n\nExploratory objectives include the collection of physical activity status and pulse rate variability at specified timepoints to provide supportive contextual information alongside participant-reported outcomes.",[205],"Gastrointestinal Health",[207,208,205,209,210,211,212,213,214,215,216,217],"Bovine Colostrum","Colostrum","Gut Health","Digestive Health","Gut Microbiome","Immune Resilience","Sleep","Energy","Dietary Supplement","Skin health","Hair health","NOT_YET_RECRUITING","2026-09-28",{"date":221,"type":222},"2026-10-05","ACTUAL",{"date":224,"type":199},"2026-09-04",{"date":226,"type":199},"2028-09-01",{"name":5,"class":6},1]