NCT06524674

Clinical Study to Compare the Effect of an Oral Rehydration Solution on the Rate of Absorption of Functional Ingredients

A Single-Blind, Controlled, Cross-Over Clinical Study to Compare the Effect of an Oral Rehydration Solution on the Rate of Absorption of Functional Ingredients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Liquid I.V. · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to compare the individual pharmacokinetics of functional ingredients included in an oral rehydration solution (ORS) with or without the inclusion of active base ingredients (carbohydrate and electrolytes). The functional ingredients included in both the control and test solutions were Melatonin in conjunction with L-theanine (Arm 1), Caffeine in conjunction with L-theanine (Arm 2), and Vitamin C in conjunction with Zinc (Arm 3), across two study periods. The primary outcomes of this study included the relative pharmacokinetics of each functional ingredient. These included: maximum observed concentration (C max), time of maximum observed concentration (T max), cumulative Area Under the Curve (AUC) for each timepoint, (including AUC from the time of dosing to the time of last observation) and the concentration at each timepoint for the corresponding functional ingredients included in the specific study arm (i.e., melatonin, L-theanine, caffeine, vitamin C and zinc).

Conditions

• Absorption
• Pharmacokinetic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Hydration Multiplier + Energy	Participants will be administered one oral serving of an oral rehydration solution containing caffeine and l-theanine
DIETARY_SUPPLEMENT	Hydration Multiplier + Sleep	Participants will be administered one oral serving of an oral rehydration solution containing melatonin and l-theanine
DIETARY_SUPPLEMENT	Energy Comp	Participants will be administered one oral serving of a comparator oral rehydration solution containing caffeine and l-theanine
OTHER	Sleep Comp	Participants will be administered one oral serving of a comparator oral rehydration solution containing melatonin and l-theanine

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-01-31
• Completion: 2024-05-31
• First posted: 2024-07-29
• Last updated: 2024-07-29

Locations

1 site across 1 country: United States