Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-28 @ 1:57 AM
Study NCT ID:
NCT06185595
Status:
COMPLETED
Last Update Posted:
2025-01-03
First Post:
2023-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Glycerol-Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest
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': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-02', 'studyFirstSubmitDate': '2023-12-08', 'studyFirstSubmitQcDate': '2023-12-28', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fluid balance', 'timeFrame': 'Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes', 'description': 'Change in body mass to the nearest 0.005 kilogram (kg) using a platform scale'}], 'secondaryOutcomes': [{'measure': 'Fluid retention', 'timeFrame': 'Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes', 'description': 'As a percent (%)'}, {'measure': 'Urine mass', 'timeFrame': 'Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes', 'description': 'By urine mass scale in grams (g)'}, {'measure': 'Urine specific gravity', 'timeFrame': 'Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes', 'description': 'By USG digital pen refractometer'}, {'measure': 'Blood sodium', 'timeFrame': 'Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes', 'description': 'By iSTAT Blood Electrolyte and Chemistry Analyzer (CG8+ cartridge) in mmol/L'}, {'measure': 'Blood glucose', 'timeFrame': 'Screening visit only', 'description': 'Glucometer for point of care test in mg/dL'}, {'measure': 'Blood glucose', 'timeFrame': 'Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes', 'description': 'By iSTAT Blood Electrolyte and Chemistry Analyzer (CG8+ cartridge) in mg/dL'}, {'measure': 'Percent change in plasma volume', 'timeFrame': 'Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes', 'description': 'Calculated from hematocrit and hemoglobin concentration'}, {'measure': 'Serum glycerol concentration', 'timeFrame': 'Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes', 'description': 'By Sigma Aldrich glycerol assay kit in mmol/L'}, {'measure': 'Blood pressure', 'timeFrame': 'Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes', 'description': 'mmHg by automatic sphygmomanometer'}, {'measure': 'Heart rate', 'timeFrame': 'Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes', 'description': 'Beats per minute (bpm) by heart rate monitor'}, {'measure': 'Subjective measures of gastrointestinal discomfort and headache', 'timeFrame': 'Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes', 'description': 'Visual Analog Scale (VAS) symptom rating of how you feel right now by placing a slash along a 100 millimeter (mm) vertical line anchored from 0 mm (None) to 100 mm (Severe). Fewer symptoms and lower numbers are better.'}, {'measure': 'Menstrual cycle phase', 'timeFrame': 'Female participants log menstrual flow throughout study participation. The three study sessions (2-45 days apart) are scheduled to avoid menses and can be completed in the same menstrual cycle, or in 3 different cycles (3 different months) if needed.', 'description': 'Date of last menstrual period by self-report of female participant'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hydration', 'euhydration', 'fluid balance', 'fluid retention'], 'conditions': ['Hydration']}, 'referencesModule': {'references': [{'pmid': '41138915', 'type': 'DERIVED', 'citation': 'Baker LB, Hinkley JM, Ozga M, Alfred SL, Merritt JR, De Chavez PJD. A randomized trial modeling the effects of solutions with low to moderate glycerol and sodium concentrations on fluid balance in healthy, active adults. Am J Clin Nutr. 2025 Oct 23:S0002-9165(25)00615-X. doi: 10.1016/j.ajcnut.2025.10.011. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the effect of consumption of drinks with varying amounts of glycerol and electrolytes on fluid balance at rest.'}, '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* You are 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 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\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/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': 'NCT06185595', 'briefTitle': 'Effect of Glycerol-Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest', 'organization': {'class': 'INDUSTRY', 'fullName': 'PepsiCo Global R&D'}, 'officialTitle': 'Effect of Glycerol-Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest', 'orgStudyIdInfo': {'id': 'PEP-2311'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'No sodium, No glycerol', 'interventionNames': ['Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.']}, {'type': 'EXPERIMENTAL', 'label': 'Sodium only group 1', 'description': '55 mmol/L sodium', 'interventionNames': ['Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.']}, {'type': 'EXPERIMENTAL', 'label': 'Glycerol only', 'description': '4.6% glycerol', 'interventionNames': ['Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.']}, {'type': 'EXPERIMENTAL', 'label': 'Sodium and Glycerol group 1', 'description': '55 mmol/L sodium and 4.6% glycerol', 'interventionNames': ['Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.']}, {'type': 'EXPERIMENTAL', 'label': 'Sodium only group 2', 'description': '27.5 mmol/L sodium', 'interventionNames': ['Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.']}, {'type': 'EXPERIMENTAL', 'label': 'Sodium and Glycerol group 2', 'description': '27.5 mmol/L sodium and 2.3% glycerol', 'interventionNames': ['Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.']}], 'interventions': [{'name': 'Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.', 'type': 'OTHER', 'description': '9.3 oz (273 ml) aliquot of one of the study beverages every 15 min for a total of 28 oz (828 ml) over a 45-min period, followed by 15 min of rest. Flavored water matched for sweetness, color. flavor, but cannot be matched for saltiness. All sodium-containing drinks will include a base blend of other electrolytes (potassium 15 mmol/L, magnesium 8 mmol/L, and calcium 5 mmol/L).', 'armGroupLabels': ['Control', 'Glycerol only', 'Sodium and Glycerol group 1', 'Sodium and Glycerol group 2', 'Sodium only group 1', 'Sodium only group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'PepsiCo R&D, Gatorade Sports Science Institute', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}], 'overallOfficials': [{'name': 'Lindsay Baker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PepsiCo, Inc. Sports Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PepsiCo Global R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}