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Glycerol only for Hydration

N/A
Recruiting
Led By Lindsay Baker, PhD
Research Sponsored by PepsiCo Global R&D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is 18-50 years of age, inclusive
If female, subject is not pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline (pre-beverage) to post-beverage time 0, 30, 60, 90,120 and 180 minutes
Awards & highlights

Study Summary

This trial aims to find out how different drinks containing glycerol and electrolytes affect the body's fluid balance when a person is at rest.

Who is the study for?
This trial is for healthy men and women who are well-hydrated. Specific details about age, health conditions, or other factors that would determine eligibility are not provided.Check my eligibility
What is being tested?
The study is testing the impact of different glycerol-electrolyte beverage blends on body fluid balance when participants are at rest. Each participant will try 3 out of 6 possible drink combinations in a random sequence.See study design
What are the potential side effects?
Potential side effects aren't specified but may include changes in hydration levels or electrolyte imbalances due to the consumption of glycerol-electrolyte beverages.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 50 years old.
Select...
I am not pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline (pre-beverage) to post-beverage time 0, 30, 60, 90,120 and 180 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (pre-beverage) to post-beverage time 0, 30, 60, 90,120 and 180 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fluid balance
Secondary outcome measures
Blood glucose
Blood pressure
Blood sodium
+8 more

Side effects data

From 2015 Phase 4 trial • 80 Patients • NCT02117687
5%
Eye Irritation
5%
Eye Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
OPTIVE FUSION™
VISMED® Multi

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Sodium only group 2Experimental Treatment1 Intervention
27.5 mmol/L sodium
Group II: Sodium only group 1Experimental Treatment1 Intervention
55 mmol/L sodium
Group III: Sodium and Glycerol group 2Experimental Treatment1 Intervention
27.5 mmol/L sodium and 2.3% glycerol
Group IV: Sodium and Glycerol group 1Experimental Treatment1 Intervention
55 mmol/L sodium and 4.6% glycerol
Group V: Glycerol onlyExperimental Treatment1 Intervention
4.6% glycerol
Group VI: ControlPlacebo Group1 Intervention
No sodium, No glycerol

Find a Location

Who is running the clinical trial?

PepsiCo Global R&DLead Sponsor
89 Previous Clinical Trials
12,619 Total Patients Enrolled
Lindsay Baker, PhDPrincipal InvestigatorPepsiCo, Inc. Sports Science
3 Previous Clinical Trials
1,205 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for participants in this ongoing trial?

"Indeed, clinicaltrials.gov affirms that this investigation is actively seeking individuals to participate. The trial was initially published on January 1st, 2024 and last revised on December 28th, 2023."

Answered by AI

What are the eligibility criteria for individuals interested in participating in this research project?

"In order to be eligible for participation in this clinical trial, patients must meet the inclusion criteria of being adequately hydrated and falling within the age range of 18 to 50. The study aims to recruit a total of 42 individuals."

Answered by AI

What is the total number of individuals participating in this clinical trial?

"Indeed, the details available on clinicaltrials.gov affirm that this investigation is presently in search of eligible individuals. The initial posting of this trial took place on January 1st, 2024 and its most recent revision occurred on December 28th, 2023. This particular study aims to recruit a total of 42 participants from a single designated site."

Answered by AI

Can individuals who are above the age of 35 be considered as potential candidates for participation in this research?

"As per the eligibility requirements outlined in this trial, individuals wishing to participate must be at least 18 years old but no older than 50 years."

Answered by AI
~21 spots leftby Aug 2024