Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-27 @ 11:27 PM
Study NCT ID:
NCT07217834
Status:
RECRUITING
Last Update Posted:
2025-10-17
First Post:
2025-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Glycerol-Electrolyte Beverage on Fluid Balance in Healthy Euhydrated Men and Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2025-10-08', 'studyFirstSubmitQcDate': '2025-10-13', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fluid balance', 'timeFrame': 'Through study completion, average of 3 weeks', 'description': 'Calculated as change in nude body mass, %'}], 'secondaryOutcomes': [{'measure': 'Fluid Balance', 'timeFrame': 'Through study completion, average of 3 weeks', 'description': 'Calculated as change in nude body mass, kg'}, {'measure': 'Urine Mass', 'timeFrame': 'Through study completion, average of 3 weeks', 'description': '(g)'}, {'measure': 'Beverage Hydration Index', 'timeFrame': 'Through study completion, average of 3 weeks', 'description': 'calculated as the cumulative urine mass after drinking the placebo divided by the cumulative urine mass after drinking the test beverage'}, {'measure': 'Urine specific gravity', 'timeFrame': 'Through study completion, average of 3 weeks', 'description': '(au)'}, {'measure': 'Blood Pressure', 'timeFrame': 'Through study completion, average of 3 weeks', 'description': 'systolic/diastolic (mmHg)'}, {'measure': 'Heart Rate', 'timeFrame': 'Through study completion, average of 3 weeks', 'description': 'bpm'}, {'measure': 'Subjective measures of thirst, gastrointestinal discomfort, lightheadedness and headache', 'timeFrame': 'Through study completion, average of 3 weeks', 'description': 'Rated on a 100-pt scale from none to extreme/severe for headache, lightheaded, stomach upset, nausea, abdominal discomfort, stomach fullness, thirsty, and hydrated.'}, {'measure': 'Menstrual categorization', 'timeFrame': 'Reported by female subjects one time at screening visit.', 'description': 'Menstrual categorization chart (Elliott-Sale, 2023). Current status (e.g., contraception, regular periods or not, etc.).'}, {'measure': 'Adverse Events', 'timeFrame': 'Through study completion, average of 3 weeks.', 'description': 'Documented changes in health and symptoms. Documented both in clinic and between visits in a provided paper log reviewed at each visit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hydration', 'electrolytes', 'glycerol', 'beverage'], 'conditions': ['Fluid Balance']}, 'descriptionModule': {'briefSummary': 'Glycerol and sodium are osmotically-active ingredients that promote fluid retention via renal water reabsorption. The purpose of this study is to compare the effects of a glycerol-electrolyte beverage on fluid balance in healthy euhydrated men and women'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is male or female\n* If female, subject is not pregnant\n* Subject is 18-50 years of age, inclusive\n* 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, laxatives, weight loss drugs)\n* Subject has no health conditions that would interfere with the study (e.g. cardiovascular, renal, or metabolic diseases)\n* Subject is not allergic to fuji apple pear flavoring\n* Subject is not allergic to Stevia\n* Subject is willing to avoid alcohol consumption 24 hours prior to visits\n* Subject is willing to fast overnight (\\~8-10 hours) prior to visits\n* Subject is willing to refrain from vigorous exercise for 24 hours\n* Subject is willing to eat the exact same food the day prior to each study session.\n* Willing and able to provide signed informed consent to participate in the study and to comply with all study procedures and scheduled visits.\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 3 months\n* Subject has a condition or is taking medication that the investigator believes would interfere with his/her 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.'}, 'identificationModule': {'nctId': 'NCT07217834', 'briefTitle': 'Effects of a Glycerol-Electrolyte Beverage on Fluid Balance in Healthy Euhydrated Men and Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'PepsiCo Global R&D'}, 'officialTitle': 'Effects of a Glycerol-Electrolyte Beverage on Fluid Balance in Healthy Euhydrated Men and Women', 'orgStudyIdInfo': {'id': 'PEP-2511'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Beverage', 'description': 'Base beverage, no electrolytes, no glycerol', 'interventionNames': ['Other: Placebo beverage, kiwi-strawberry flavor']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Beverage', 'description': 'Glycerol beverage with electrolytes', 'interventionNames': ['Other: Experimental glycerol beverage, kiwi-strawberry flavor']}], 'interventions': [{'name': 'Placebo beverage, kiwi-strawberry flavor', 'type': 'OTHER', 'description': '3 equal aliquots totaling 1 liter over a 30 min period, finishing each aliquot within 5 min followed.', 'armGroupLabels': ['Placebo Beverage']}, {'name': 'Experimental glycerol beverage, kiwi-strawberry flavor', 'type': 'OTHER', 'description': '3 equal aliquots totaling 1 liter over a 30 min period, finishing each aliquot within 5 min followed.', 'armGroupLabels': ['Experimental Beverage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34210', 'city': 'Bradenton', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Lindsay.Baker@pepsico.com', 'phone': '8008842867'}, {'role': 'CONTACT', 'email': 'Lindsay.Baker@pepsico.com'}], 'facility': 'IMG Academy/GSSI Bradenton Gatorade Sports Science Institute', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}], 'centralContacts': [{'name': 'Lindsay Baker, PhD', 'role': 'CONTACT', 'email': 'Lindsay.Baker@pepsico.com', 'phone': '800.884.2867'}], 'overallOfficials': [{'name': 'Lindsay Baker', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PepsiCo R&D/Gatorade and Sports Science Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PepsiCo Global R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}