Efficacy of Different Oral Rehydration Solutions on the Hydration Status of Healthy Males

Fluid Retention Clinical Trial

Official title:

Efficacy of Different Oral Rehydration Solutions on the Hydration Status of Healthy Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05428774
• Other study ID #: Pilot
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: January 2023
• Source: Liquid I.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dehydration lowers both physical and mental performance if it is severe enough. Performance declines are more pronounced in hot conditions or after prolonged strenuous activity such as exercise. Most individuals drink less than their sweat losses during activity, while some individuals overdrink and develop a sodium deficiency. Water and electrolyte balance must be restored as part of the recovery process after any activity that causes sweating. Plain water causes a decrease in plasma sodium concentration and osmolality, which reduces the desire to drink and increases urine production. Unless the volume ingested exceeds the loss, individuals are in net negative fluid balance throughout the recovery period due to urinary losses. When sodium and potassium are added to rehydration fluids, urine production is reduced in the hours following rehydration. Rehydration is only possible if a volume of fluid equal to or greater than the amount lost through sweat is consumed, together with adequate electrolytes. The two test products for this study, are novel hydration beverage formulas. They are an electrolyte drink mixture with five essential vitamins and three times more electrolytes than typical sports beverages. The test products create an osmotic force that permits water to be supplied to the bloodstream sooner in the digestive system by using a specific ratio of sodium, glucose, and potassium. This randomized, placebo-controlled, semi-blind, crossover study will evaluate the effects of the test products on rehydration in healthy adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 1, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy males 18-35 years old at the time of screening. Participants need to be competent i.e., able to understand what is to take place and able to provide a free decision on agreeing to the activity/taking part in the study. Participants must be able to read and understand study instructions and any other relevant study documents. Willing to following the lifestyle and dietary restrictions as detailed in the Information Sheet for study.

Exclusion Criteria:

• A history or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder. Consumption other nutritional supplements, performance enhancing drugs, and non-steroidal anti-inflammatory drugs (NSAIDs) during the clinical. Participant has any medical condition which alters fluid balance in the body as confirmed by a health history questionnaire. Following a dietary pattern which may alter our findings (e.g., low carbohydrate/ketogenic diet, carnivore diet, intermittent fasting etc.). Women are excluded due to the variability of fluid retention during the menstrual cycle. Participant is not currently enrolled in another clinical study. Participant is consuming any medication which may alter fluid retention such as diuretics. The participant is an employee of the Sponsor.

Related Conditions & MeSH terms

• Fluid Retention
• Hydration Status

Intervention

Other:
• Test product 1
Participants will receive TP1 during one experimental visit.
• Test product 2
Participants will receive TP2 during one experimental visit.
• Placebo
Participants will receive placebo during one experimental visit.

Locations

Country	Name	City	State
United States	Lipscomb University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Liquid I.V.	Lipscomb University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beverage hydration index	The primary objective of this study is to investigate the efficacy of two different oral rehydration solutions on the hydration status in healthy males via the beverage hydration index	Through study completion, average of 6 weeks
Primary	Hydration status	The primary objective of this study is to investigate the efficacy of two different oral rehydration solutions on the hydration status in healthy males via urine specific gravity analysis.	Through study completion, average of 6 weeks