[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06654557":3,"trial-entities:NCT06654557":170,"trial-summary:NCT06654557":174},{"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":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":58,"secondary_outcomes":65,"sex":113,"minimum_age":114,"maximum_age":115,"healthy_volunteers":116,"eligibility_criteria":117,"std_ages":138,"locations":140,"central_contacts":162,"overall_officials":165,"references":168,"see_also_links":169},"NCT06654557","PEP-2412","Effect of Adding Glycerol to Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest","RECRUITING","2025-05-30","2025-02","2025-02-11","2024-09-30","PepsiCo Global R&D","INDUSTRY",false,"The results of a prior study PEP-2311 suggested there was a positive dose-response effect of glycerol and sodium on fluid balance and fluid retention. In addition, inclusion of glycerol resulted in an upward shift in the relationship between sodium concentration and fluid balance. The practical interpretation is that addition of glycerol enables a reduction in sodium concentration compared with a 0% glycerol drink.\n\nIn this follow-up study, the investigators hypothesize that 1) fluid balance will be sustained (greater than or not different from baseline) and significantly greater than placebo for 120 min after drinking the test no\u002Flow\u002Fmoderate carbohydrate beverages and 2) fluid balance will not differ between the carbohydrate-electrolyte beverages, but both will be greater than placebo.","This is a two-part study. Subjects will be asked to complete either Part 1 or Part 2 of this study. Subjects can participate in both parts of the study if they are interested and available to complete all trials. However, they will be asked to complete Part 1 before enrolling in Part 2 of the study. Dosing days are separated by 2-15 days.\n\nObjective 1) To compare the effect of consumption of four no\u002Flow\u002Fmoderate carbohydrate drinks with high electrolyte concentrations vs. placebo on fluid balance at rest. To enroll N=25\n\nObjective 2) To compare the effect of consumption of two moderate carbohydrate drinks with low electrolyte concentrations vs. placebo on fluid balance at rest. To enroll N=70",[18],"Fluid Balance",[20,21,22,23,24],"hydration","electrolytes","glycerol","carbohtydrate","beverage","INTERVENTIONAL","BASIC_SCIENCE",[28],"NA",{"count":30,"type":31},95,"ESTIMATED",[33,39,43,46,49,52,55],{"type":34,"name":35,"description":36,"armGroupLabels":37},"OTHER","Placebo beverage, kiwi-strawberry flavor (Part 1 and Part 2)","9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose.",[38],"Placebo beverage (Parts 1 and 2)",{"type":34,"name":40,"description":41,"armGroupLabels":42},"0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only)","9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.",[40],{"type":34,"name":44,"description":41,"armGroupLabels":45},"0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only)",[44],{"type":34,"name":47,"description":41,"armGroupLabels":48},"1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)",[47],{"type":34,"name":50,"description":41,"armGroupLabels":51},"6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)",[50],{"type":34,"name":53,"description":41,"armGroupLabels":54},"6% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)",[53],{"type":34,"name":56,"description":41,"armGroupLabels":57},"2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)",[56],[59,63],{"measure":60,"description":61,"timeFrame":62},"Fluid balance (Body Weight)","Platform scale to the nearest 0.005 kilograms (kg)","Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage",{"measure":64,"description":61,"timeFrame":62},"Fluid balance (Percent (%) change in Body Mass)",[66,70,73,76,79,82,85,88,91,94,97,100,103,106,109],{"measure":67,"description":68,"timeFrame":69},"Fluid retention","Platform scale to the nearest 0.005 kilograms (kg), unit percent (%)","% change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage",{"measure":71,"description":72,"timeFrame":62},"Urine mass","Graduated cylinder on scale to the nearest 0.01 grams",{"measure":74,"description":75,"timeFrame":62},"Urine specific gravity","USG digital pen refractometer (Atago), no unit",{"measure":77,"description":78,"timeFrame":62},"Blood sodium","Fingerstick sampling, unit millimoles per liter (mmol\u002FL), iSTAT Blood Electrolyte and Chemistry Analyzer (CHEM8+ cartridge)",{"measure":80,"description":81,"timeFrame":62},"Blood glucose","Fingerstick sampling, unit milligrams per deciliter (mg\u002Fdl), iSTAT Blood Electrolyte and Chemistry Analyzer (CHEM8+ cartridge)",{"measure":83,"description":84,"timeFrame":62},"Percent change in plasma volume","Fingerstick sampling, calculated from hematocrit and hemoglobin concentration percent (%)",{"measure":86,"description":87,"timeFrame":62},"Serum glycerol concentration","Fingerstick sampling unit millimoles per liter (mmol\u002FL) using Sigma Aldrich glycerol assay kit",{"measure":89,"description":90,"timeFrame":62},"Serum osmolality","Fingerstick sampling, unit milliosmoles per kilogram of water (mOsm\u002FKg H20)",{"measure":92,"description":93,"timeFrame":62},"Saliva osmolality","Measured directly from the tongue using a handheld MX3 Diagnostics device, unit milliosmoles per kilogram of water (mOsm\u002Fkg H2O)",{"measure":95,"description":96,"timeFrame":62},"Blood pressure (systolic\u002Fdiastolic)","Automatic sphygmomanometer unit millimeters of mercury (mm\u002FHg)",{"measure":98,"description":99,"timeFrame":62},"Heart rate","Heart rate monitor, unit beats per minute (bpm)",{"measure":101,"description":102,"timeFrame":62},"Subjective measure of headache","One item on a 100 point visual analog scale anchored from 0=No headache to 100=Severe headache",{"measure":104,"description":105,"timeFrame":62},"Subjective measure of lightheadedness","One item on a 100 point visual analog scale anchored from 0=No lightheadedness to 100=Severe lightheadedness",{"measure":107,"description":108,"timeFrame":62},"Subjective measures of gastrointestinal discomfort","Eight items on a 100 point visual analog scale (stomach upset, nausea, burping, stomach bloating, abdominal discomfort, stomach fullness, vomiting, diarrhea anchored frrom 0= None to 100=Severe",{"measure":110,"description":111,"timeFrame":112},"Menstrual categorization","Using Elliott-Sale chart, 2023 to categorize menstrual\u002Fhormonal contraceptive status for those who have not yet reached perimenopause\u002Fmenopause. This is a decision-tree chart, not a scale.","Assessed at Screening Visit","ALL","18 Years","50 Years",true,{"inclusion":118,"exclusion":132,"raw_text":137},[119,120,121,122,123,124,125,126,127,128,129,130,131],"If female, subject is not pregnant (based on self-report)","Subject is 18-50 years of age, inclusive Subject is at least recreationally active (engaged in light to moderate intensity, intermittent, or steady-state exercise at least 3 days per week for at least 30 min at a time)","Subject does not smoke (or has quit for at least 6 months)","Subject is not taking medication that may interfere with the study (e.g., diuretics)","Subject has no health conditions that would interfere with the study, As indicated on the general health questionnaire (GHQ), e.g. cardiovascular, renal, or metabolic diseases","Subject is not allergic to adhesives (e.g., medical tape)","Subject is not allergic to kiwi-strawberry flavoring","Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)","Subject is willing to fast overnight (\\~8-12 hours)","Subject is willing to refrain from vigorous exercise for 24 hours (light physical activity only)","Subject is willing to eat the exact same food the day prior to each visit to the laboratory","Able to speak, write, and read English","Provision of written consent to participate",[133,134,135,136],"Subject has participated in a clinical trial within the past 30 days","Subject has participated in any PepsiCo trial within past 6 months","Subject has a condition or is taking medication that the investigator believes would interfere with his\u002Fher ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the person at undue risk","Subject is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If subject is unsure if a company would be considered a competitor to Gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.","Inclusion Criteria:\n\nSubject is male or female\n\n* If female, subject is not pregnant (based on self-report)\n* Subject is 18-50 years of age, inclusive Subject is at least recreationally active (engaged in light to moderate intensity, intermittent, or steady-state exercise at least 3 days per week for at least 30 min at a time)\n* Subject does not smoke (or has quit for at least 6 months)\n* Subject is not taking medication that may interfere with the study (e.g., diuretics)\n* Subject has no health conditions that would interfere with the study, As indicated on the general health questionnaire (GHQ), e.g. cardiovascular, renal, or metabolic diseases\n* Subject is not allergic to adhesives (e.g., medical tape)\n* Subject is not allergic to kiwi-strawberry flavoring\n* Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)\n* Subject is willing to fast overnight (\\~8-12 hours)\n* Subject is willing to refrain from vigorous exercise for 24 hours (light physical activity only)\n* Subject is willing to eat the exact same food the day prior to each visit to the laboratory\n* Able to speak, write, and read English\n* Provision of written consent to participate\n\nExclusion Criteria:\n\n* Subject has participated in a clinical trial within the past 30 days\n* Subject has participated in any PepsiCo trial within past 6 months\n* Subject has a condition or is taking medication that the investigator believes would interfere with his\u002Fher ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the person at undue risk\n* Subject is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If subject is unsure if a company would be considered a competitor to Gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.",[139],"ADULT",[141],{"facility":142,"status":7,"city":143,"state":144,"zip":145,"country":146,"contacts":147,"geoPoint":159},"PepsiCo R&D, Gatorade Sports Science Institute","Valhalla","New York","10595","United States",[148,153,157],{"name":149,"role":150,"phone":151,"email":152},"Lindsay Baker, PhD","CONTACT","814-883-9454","lindsay.baker@pepsico.com",{"name":154,"role":150,"phone":155,"email":156},"Matthew Hinkley, PhD","914-742-4975","Matt.Hinkley@pepsico.com",{"name":149,"role":158},"PRINCIPAL_INVESTIGATOR",{"lat":160,"lon":161},41.07482,-73.77513,[163],{"name":149,"role":150,"phone":151,"email":164},"Lindsay.Baker@pepsico.com",[166],{"name":149,"affiliation":167,"role":158},"PepsiCo R&D Life Sciences, Sports Science",[],[],{"nct_id":4,"conditions":171,"biomarkers":173},[172],"Healthy",[],{"nct_id":4,"found":116,"summary":175,"prompt_version":185},{"design":176,"status":177,"heading":178,"summary":179,"follow_up":180,"word_count":181,"commitments":182,"compensation":183,"drugs_mentioned":184},"This is an interventional study planning to enroll 95 healthy men and women. Participants will receive different beverage interventions, including placebo and various electrolyte solutions with or without glycerol.","completed","Study on Glycerol and Electrolyte Beverages for Fluid Balance","This study is looking at how different electrolyte drinks, some with added glycerol, affect your body's fluid balance. Researchers want to see if these drinks help you retain fluids better than a plain placebo drink. They are testing several variations: a 0% carbohydrate electrolyte solution with or without glycerol, and 1% and 6% carbohydrate electrolyte solutions, all with glycerol. You might be able to join if you are a healthy man or woman between 18 and 50 years old, are recreationally active, and do not smoke. The study will measure changes in your body weight to see how well you retain fluids after drinking these beverages. The goal is to find out if adding glycerol helps maintain fluid balance.","Your fluid balance will be monitored for 150 minutes after you finish drinking the test beverages on each study day.",119,"You will drink 28 ounces of a test beverage over 35 minutes, followed by a 25-minute rest. Your fluid balance will be measured at several time points up to 150 minutes after the last drink. Dosing days are separated by 2-15 days.","Not stated in the trial record.",[],"v2"]