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

NCT06524674 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2024-07-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Princeton Consumer Research

    collaborator OTHER

  • Liquid I.V.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-01-31
Completion
2024-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06524674 on ClinicalTrials.gov