Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-26 @ 2:24 PM
Study NCT ID:
NCT06858904
Status:
COMPLETED
Last Update Posted:
2025-09-05
First Post:
2025-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehydration With a Trace Mineral Supplement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003681', 'term': 'Dehydration'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2025-02-28', 'studyFirstSubmitQcDate': '2025-02-28', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Net Fluid Balance', 'timeFrame': 'at 60 minutes, 120 minutes, 180 minutes and 240 minutes of rehydration', 'description': 'Body water Retention after exercise-induced dehydration'}, {'measure': 'Urine volume', 'timeFrame': '1, 2, 3, and 4 hour of the rehydration period', 'description': 'Urine volume during the rehydration period'}, {'measure': 'Free water clearance', 'timeFrame': '1, 2, 3, and 4 hours of the rehydration period', 'description': 'Free water clearance during the rehydration period'}, {'measure': 'Osmotic Clearance', 'timeFrame': '1, 2, 3, and 4 hours of the rehydration period', 'description': 'Osmotic renal clearance during the rehydration period'}, {'measure': 'Skin Hydration', 'timeFrame': '1, 2, 3, and 4 hours of the rehydration period', 'description': 'Skin hydration at the face assessed with a moisture meter.'}], 'secondaryOutcomes': [{'measure': 'Plasma Volume', 'timeFrame': '1, 2, 3, and 4 hours of the rehydration period', 'description': 'Changes in Plasma Volume during rehydration based on hematocrit and hemoglobin'}, {'measure': 'Stomach fullness', 'timeFrame': '1, 2, 3, and 4 hours of the rehydration period', 'description': 'Stomach fullness assessed during dehydration'}, {'measure': 'Gastrointestinal symptoms', 'timeFrame': 'At the end of the 4 hours rehydration period', 'description': 'Gastrointestinal symptoms assessed with the structured assessment of gastrointestinal symptoms scale'}, {'measure': 'Plasma Osmolality', 'timeFrame': '1, 2, 3, and 4 hours of the rehydration period', 'description': 'Plasma osmolality during rehydration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rehydration', 'sports drinks', 'fluid balance', 'water retention'], 'conditions': ['Dehydration (Physiology)']}, 'descriptionModule': {'briefSummary': 'It is well established that post-exercise rehydration with electrolyte solutions is more effective than plain water. However, most commercially available drinks are high in electrolytes but lack some essential trace minerals. This study aims to examine the impact of a higher-electrolyte sports drink compared with a low-electrolyte, trace-mineral-rich solution and water on the time course and extent of rehydration after exercise-induced dehydration.', 'detailedDescription': 'Protocol Before the start of the study eligible participants will visit our lab to conduct a screening of medical history, weight, height, and a onetime assessment of body composition via BIA and Training history. This visit will take place at least one day before the actual start of the study and typically lasts no longer than 30 minutes. During this visit participants will be given two questionnaires, one regarding the physical activity readiness of the participant, and another one regarding their health history. If a participant does not meet the physical criteria and does not pass both questionnaires, they will be given a $25 digital Tango gift card for their brief visit to our lab. Participants who do pass will be given a scheduled date and time to visit the lab again for their first official trial.\n\nAt the start of the study subjects will visit the lab after at least 10h of fast and they will consume a light breakfast. An intravenous catheter will be place in an antecubital vein and a blood sample will be taken after 20 min for baseline. A baseline skin hydration reading will also be taken at this time. Subjects will void their bladders and a body weight will be taken.\n\nDehydration:\n\nConsistent with the study by Shirreffs et al (2007) and based on our previous work, dehydration will be accomplished on the morning of testing via mild exercise and heat exposure to elicit a body weight loss of -2%. The subjects will perform four bouts of 25-minutes low-intensity exercise and 5 min rest (alternating cycling \\& walking) or till they reach -2% of body weight dehydration.\n\nRehydration:\n\nUpon losing 2% body weight, participants will be instructe to rinse off their face to get rid of excess sweat. This is followed by a 20 minutes rest period in a thermo-comfortable environment, a dehydrated baseline blood sample will be taken, along with a dehydrated skin hydration reading and subject will start the rehydration protocol.\n\nThe volunteers will consume one of the three drinks below in a cross over balance mode. During the first hour four equal doses will be consumed in15-minutes intervals at a total volume of 150% of their body weight loss.\n\nTrials/Drinks (block randomization will be used to assign individual participants to each specific trial/drink using their ID number):\n\n* Water\n* ConcenTrace®\n* ZEROLyte™ Note: The beverage volumes will be standardized at 150% of body weight loss during exercise-induced dehydration to ensure consistency across trials.\n\nSee the study design expressed as a figure below:\n\nMeasurements:\n\nAll measurements will be performed at one of the test rooms at our lab facility that boarders the room where participants can relax and wait out the end of the study day. When certain measurements need to be performed they simply move from one room to the next. Duration of taking blood and urine samples will take not more than 30-90 seconds each and perceptual data will take 30-60 seconds to be reported. To allow to perform all measurements, participants will remain supervised by a team member in the lab for up to 7 hours per trial. Therefore, there will be a separate space available that allows for self-study or watching TV that includes a chair and table to work on and a couch to relax.\n\nBlood samples (7 per trial):\n\nBlood samples will be taken via a venous catheter attached to an extension tube and a stopcock. After each blood sample sterile saline solution will be infused in the extention tube to avoid clotting. The iv catheter will be placed by one of the Clinical Research Center phlebotomists. A total of seven 10 milliliters blood samples will be collected on the euhydrated baseline, dehydrated baseline and at 30, 60, 120, 180, and 240 minutes of the rehydration period.\n\nAll samples will be analyzed for glucose, osmolality, total plasma protein, hematocrit, hemoglobin (for plasma volume changes), sodium, potassium, and chloride.\n\nUrine samples (6 per trial):\n\nUrine samples will be provided from the subjects in a urine cup. The cup will be placed in the pass-through window where a lab technician will receive it and process it.\n\nUrine samples will be collected using \\~900 milliliters cups at euhydrated baseline, dehydrated baseline and cumulative totals will be collected at 60, 120, 180, and 240 minutes of the rehydration period. All samples will be analyzed for urine osmolality, specific gravity, volume, sodium, and potassium.\n\nSweat samples (1 per trial):\n\nSweat samples will be collected with sweat patches. The sweat patches are like a band-aid that it will be placed on the forearm and stay there for approximately 30 min to absorb sweat. After 30 minutes the patch will be removed and the sweat sample will be extracted by centrifugation in the lab.\n\nSweat samples will be collected during the first 30 min of exercise to assess sodium and potassium content.\n\nSkin Hydration (6 per trial):\n\nSkin hydration will be measured with a pen-like instrument that applies a very light pressure on the skin. This does not cause any pain or skin irritation.\n\nSkin hydration will be measured on the face (inner zygomatic bone), arm (bicep brachii) at euhydrated baseline, 30 minutes after the end of dehydration, and at 60, 120, 180, and 240 minutes of rehydration.\n\nGastrointestinal Symptoms (6 per trial):\n\nGastrointestinal symptoms will be assessed at 1, 2, 3 and 4 hours of rehydration via Gastrointestinal Symptom Rating Scale (GSRS).\n\nPerceptual Data (6 per trial, maximal 9 minutes):\n\nThirst, stomach fullness, and taste, assessed via a visual analog scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recreationally physically active: Training \\> 2x per week and ≤ 6hours per week\n* BMI of 18.5-29.9\n* Stable weight for the last 2 months (\\<5 pounds. fluctuation)\n\nExclusion Criteria:\n\n* Women who are pregnant, breast feeding, or planning to become pregnant during the trial\n* night shifting work\n* thyroid medication\n* bariatric surgery\n* cardiovascular disease\n* renal disease\n* hepatic disease\n* Participating in another study at the same time\n* Bodyweight \\<110 pounds\n* Currently Smoker\n* Major surgery, including abdominal, in the past 3 months or individuals who have planned surgery during the trial.\n* Alcohol or drug abuse within the last 12 months\n* High alcohol intake (average of \\> 2 standard drinks per day or \\> 10 standard drinks per week)'}, 'identificationModule': {'nctId': 'NCT06858904', 'acronym': 'TRACE', 'briefTitle': 'Rehydration With a Trace Mineral Supplement', 'organization': {'class': 'OTHER', 'fullName': 'Arizona State University'}, 'officialTitle': 'Rehydration With a Trace Mineral Supplement', 'orgStudyIdInfo': {'id': 'STUDY00021498'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ConcenTrace', 'description': 'Beverage with ConcenTrace minerals', 'interventionNames': ['Dietary Supplement: ConcenTrace']}, {'type': 'EXPERIMENTAL', 'label': 'ZeroLyte', 'description': 'Beverage with high level of trace elements but no sugar', 'interventionNames': ['Dietary Supplement: ZeroLyte']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Water with non caloric, non-sodium containing sweetner', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Non- calorically sweetened Water', 'armGroupLabels': ['Placebo']}, {'name': 'ConcenTrace', 'type': 'DIETARY_SUPPLEMENT', 'description': '1.25 milliliter of concentrace per liter', 'armGroupLabels': ['ConcenTrace']}, {'name': 'ZeroLyte', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Beverage with 1 pack of ZeroLyte per 500 milliliter of water', 'armGroupLabels': ['ZeroLyte']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Hydration Science Lab', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arizona State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Assistant Dean', 'investigatorFullName': 'Stavros Kavouras', 'investigatorAffiliation': 'Arizona State University'}}}}