Clinical trial

Hydration Dynamics and Influence of Beverage Composition

Name
2021-0823
Description
The study examines interactions between fluid availability in the gut and fluid retention in the body. The relative rate of fluid uptake, the expansion of the plasma volume, and percent of fluid retained by the body will be measured in response to ingestion of beverages of different composition. Healthy, euhydrated adults will be studied. The results will help establish formulations of beverages that sustain if not promote acute euhydration.
Trial arms
Trial start
2021-09-03
Estimated PCD
2022-10-31
Trial end
2022-11-30
Status
Completed
Phase
Early phase I
Treatment
Placebo
Ingestion of one (1) liter of beverage with observation for 2 h
Arms:
Placebo
Oral Rehydration Solution 1
Ingestion of one (1) liter of beverage with observation for 2 h
Arms:
Oral rehydration solution 1
Oral Rehydration Solution 2
Ingestion of one (1) liter of beverage with observation for 2 h
Arms:
Oral rehydration solution 2
Size
14
Primary endpoint
Rate of appearance of deuterium in the plasma for placebo
2 hours
Rate of appearance of deuterium in the plasma for oral rehydration solution 1.
2 hours
Rate of appearance of deuterium in the plasma for oral rehydration solution 2.
2 hours
Eligibility criteria
Inclusion Criteria: * Have a BMI of 18.5 to 29.9 kg/m2. * Be normotensive (\<120/80 mm Hg). * Must be able to speak and read English. * Be physically active or a regular exerciser but be able to abstain from exercise for 48 h prior to each study trial. * Fast for at least 8 hours prior to and through the study trial. * Be able to abstain from alcohol for 48 h prior to each study. * Be able to abstain from caffeine for 24 h prior to each study. * If female, must have regular menstrual cycles, that are \> 27 days and \< 35 days in length. Exclusion Criteria: * Under 18 y of age or over 45 y of age. * Have a BMI \<18.5 or \>30. * Being pregnant. * Lactating. * Tobacco user. * Have hypotension or hypertension. * Have any type of kidney disease or dysfunction. * Have diabetes. * Have any type of cardiovascular disease. * Have been diagnosed with galactosemia. * Females with irregular menstrual cycles. * Females with polycystic ovary disease.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Mixed model.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Beverages will have similar color, flavoring, and taste.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 14, 'type': 'ACTUAL'}}
Updated at
2023-07-14

1 organization

1 product

1 drug

3 indications

Indication
Dehydration
Indication
Edema
Indication
dehydration