[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06544915":3,"trial-entities:NCT06544915":112,"trial-summary:NCT06544915":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":36,"secondary_outcomes":47,"sex":72,"minimum_age":73,"maximum_age":74,"healthy_volunteers":75,"eligibility_criteria":76,"std_ages":81,"locations":83,"central_contacts":98,"overall_officials":102,"references":106,"see_also_links":111},"NCT06544915","2209-1044","Evaluating the Effects of a Synbiotic Versus Probiotic or Placebo on Gut Microbiota and Cardiometabolic Health: A Randomized Double-Blind Placebo Controlled Trial","RECRUITING","2025-01-01","2024-08","2024-08-09","2024-07-23","Skidmore College","OTHER",false,"Accordingly, the purpose of this study is to evaluate the efficacy of 1) supplementation with Synbiotic (Plexus® Triplex), 2) commercially-available Probiotic, or 3) placebo control over 30 days on the gut microbiome, cardiometabolic health, body weight and body composition in healthy individuals.","Specific Aim 1. Explore the changes in the gut microbiome using 16s rRNA sequencing to determine total bacterial counts, microbial diversity (alpha- and beta-diversity), short chain fatty acid (SCFA) concentration, circulating inflammatory biomarkers and mucosal immunity as a result of synbiotic vs. probiotic vs. placebo control.\n\nSpecific Aim 2. Document the functional changes in cardiometabolic health-related parameters; specifically, heart rate, heart rate variability (HRV), blood pressure (central and peripheral), vascular stiffness (augmentation index, AIx, and pulse wave velocity, PWV), body weight and composition, blood glucose and lipids as a result of synbiotic vs. probiotic vs. placebo control.\n\nSpecific Aim 3. Characterize the impact of synbiotic vs. probiotic vs. placebo control on perceptions of fullness\u002Fhunger, self-reported gastrointestinal health (questionnaire), and mood states.\n\nHypothesis: We hypothesize that the synbiotic will result in greater changes in total gut bacterial count, microbial diversity, SCFA, while reducing circulating markers of inflammation and increasing determinants of mucosal immunity. Second, the synbiotic will result in greater enhancement of cardiometabolic health over the probiotic or placebo control. Third, the synbiotic will maintain or improve perceptual indicators of fullness\u002Fhunger, gastrointestinal health, and mood states over probiotic alone or placebo control.",[18],"Blood Pressure, Body Composition, Immune Function",[],"INTERVENTIONAL","BASIC_SCIENCE",[23],"NA",{"count":25,"type":26},60,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DIETARY_SUPPLEMENT","Synbiotic, Probiotic, Placebo","Use of dietary supplements to improve gut microbiome and cardiometabolic health",[33,34,35],"Placebo","Probiotic","Synbiotic",[37,41,44],{"measure":38,"description":39,"timeFrame":40},"Gut microbial diversity","alpha- and beta-diversity","Baseline, 15 days, 30 days",{"measure":42,"description":43,"timeFrame":40},"Gut microbial count","Gut microbial species identification and quantification",{"measure":45,"description":46,"timeFrame":40},"Short Chain fatty acids","Short Chain Fatty Acid concentration",[48,51,54,57,60,63,66,69],{"measure":49,"description":50,"timeFrame":40},"Blood pressure","Brachial and estimated central blood pressure",{"measure":52,"description":53,"timeFrame":40},"Vascular Stiffness","Aortic vascular stiffness",{"measure":55,"description":56,"timeFrame":40},"Vascular reactivity","Using the near-infrared vascular occlusion test",{"measure":58,"description":59,"timeFrame":40},"Heart Rate Variability","Time and frequency domain HRV parameters",{"measure":61,"description":62,"timeFrame":40},"Dietary Analysis","Dietary analysis using the ASA24 system",{"measure":64,"description":65,"timeFrame":40},"Body Composition","Body mass, % body fat using Tanita RD 545",{"measure":67,"description":68,"timeFrame":40},"Blood Lipids","Blood lipid profile using Cholestech system",{"measure":70,"description":71,"timeFrame":40},"Salivary inflammation profile","Salimetrics ELISA for key inflammatory and immunity parameters (SIgA, IgG, alpha amylase, cortisol, c-reactive protein)","ALL","18 Years","60 Years",true,{"inclusion":77,"exclusion":78,"raw_text":80},[],[79],"Given the focus of the study those who are currently, or have recently used (\\\u003C3 months), oral antibiotics or have diagnosed irritable bowel syndrome or gut\u002Fbowel maladies (short bowel syndrome, etc.) will be excluded. Subjects who present with 2 or more CVD risk factors (table above) or have uncontrolled\u002Fovert cardiovascular, pulmonary, or metabolic disease (Diabetes Mellitus), or recent blood donation (\\\u003C8 weeks) will be excluded. Those who have cancer or are being treated for cancer will also be excluded. Women who are currently pregnant, breastfeeding, attempting to conceive, or amenorrheic (not associated with menopause or use of contraceptive medications) will also be excluded from the study. Anyone who is being treated for hypothyroid with levothyroxine will be excluded as one of the supplement ingredients, chromium polynicotinate, may interfere with this medication . Anyone with severe illness or compromised or suppressed immune system (e.g. taking immune suppressants, chronic viral infection or treatment) will be excluded. Anyone recently diagnosed (\\\u003C1yr) with an eating disorder or food allergies will also be excluded.","Inclusion Criteria:\n\n* To be included participants must be healthy, weight stable (± 4.4 lb for \\> 6 months prior), and 18 to 60 years of age. Participants will be expected to be relatively healthy without uncontrolled chronic disease (e.g. cardiovascular, metabolic, or pulmonary) and 1 or fewer positive risk factors for cardiovascular disease (e.g. high blood pressure, high cholesterol, etc.) as described by the American College of Sports Medicine\u002FAmerican Heart Association Criteria and presented in the table 1 below. Per College policy, participants who are visitors are required to be fully vaccinated against COVID-19, including a booster, and participants who are faculty, staff or students are required to be fully vaccinated against COVID-19 and receive a booster by January 24, 2022 or within 30 days of becoming eligible, unless a medical or religious exemption has been granted. Participants will be screened for eligibility by health history form in person baseline measurements are made (Figure 1). To ensure greater inclusion, ecological validity and representation, women will be included in this study; however, we will not control for menstrual cycle phase, but will document for possible statistical consideration.\n\nExclusion Criteria:\n\n* Given the focus of the study those who are currently, or have recently used (\\\u003C3 months), oral antibiotics or have diagnosed irritable bowel syndrome or gut\u002Fbowel maladies (short bowel syndrome, etc.) will be excluded. Subjects who present with 2 or more CVD risk factors (table above) or have uncontrolled\u002Fovert cardiovascular, pulmonary, or metabolic disease (Diabetes Mellitus), or recent blood donation (\\\u003C8 weeks) will be excluded. Those who have cancer or are being treated for cancer will also be excluded. Women who are currently pregnant, breastfeeding, attempting to conceive, or amenorrheic (not associated with menopause or use of contraceptive medications) will also be excluded from the study. Anyone who is being treated for hypothyroid with levothyroxine will be excluded as one of the supplement ingredients, chromium polynicotinate, may interfere with this medication . Anyone with severe illness or compromised or suppressed immune system (e.g. taking immune suppressants, chronic viral infection or treatment) will be excluded. Anyone recently diagnosed (\\\u003C1yr) with an eating disorder or food allergies will also be excluded.",[82],"ADULT",[84],{"facility":12,"status":7,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":95},"Saratoga Springs","New York","12866","United States",[90],{"name":91,"role":92,"phone":93,"email":94},"Stephen Ives, Ph.D.","CONTACT","518-580-8366","sives@skidmore.edu",{"lat":96,"lon":97},43.08313,-73.78457,[99],{"name":100,"role":92,"phone":101,"email":94},"Steve Ives, PhD","5185808366",[103],{"name":104,"affiliation":12,"role":105},"Stephen J Ives, PhD","PRINCIPAL_INVESTIGATOR",[107],{"pmid":108,"type":109,"citation":110},"39821451","DERIVED","Lang JM, Shostak ES, Quinn WK, Chervinskaya VD, Fioraso E, Smith E, Kotarsky CJ, DeBlauw JA, Lloyd JL, Ives SJ. Dyslipidemia Impacts Cardiometabolic Health and CVD Risk in a Relatively Young Otherwise Healthy Population. J Clin Hypertens (Greenwich). 2025 Jan;27(1):e14972. doi: 10.1111\u002Fjch.14972.",[],{"nct_id":4,"conditions":113,"biomarkers":117},[114,115,116],"Blood Pressure Finding","Body Position","Immune System Disorder",[],{"nct_id":4,"found":75,"summary":119,"prompt_version":129},{"design":120,"status":121,"heading":122,"summary":123,"follow_up":124,"word_count":125,"commitments":126,"compensation":127,"drugs_mentioned":128},"This is an interventional study comparing three different groups (Synbiotic, Probiotic, or Placebo) in a randomized, double-blind design with 60 planned participants.","completed","Evaluating Synbiotic, Probiotic, or Placebo for Gut Health and Cardiometabolic Health","This study is looking at how different dietary supplements affect your gut health and heart health. Researchers want to see if taking a Synbiotic (Plexus® Triplex), a commercially-available Probiotic, or a placebo (an inactive substance) for 30 days can improve your gut bacteria, blood pressure, and body composition. They will measure changes in your gut bacteria (diversity and count) and short chain fatty acids (SCFAs) at the start, 15 days, and 30 days into the study. You might be able to join if you are a healthy adult between 18 and 60 years old, with stable weight and no uncontrolled chronic diseases. The study is currently unclear on its recruitment status and plans to enroll 60 participants.","Participants will be followed for 30 days, with final measurements taken at that time.",117,"Participants will take a dietary supplement for 30 days, with measurements of gut health taken at the start, 15 days, and 30 days.","Not stated in the trial record.",[],"v2"]