Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654557
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Effect of Adding Glycerol to Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Adding Glycerol to Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The results of a prior study PEP-2311 suggested there was a positive dose-response effect of glycerol and sodium on fluid balance and fluid retention In addition inclusion of glycerol resulted in an upward shift in the relationship between sodium concentration and fluid balance The practical interpretation is that addition of glycerol enables a reduction in sodium concentration compared with a 0 glycerol drink
In this follow-up study the investigators hypothesize that 1 fluid balance will be sustained greater than or not different from baseline and significantly greater than placebo for 120 min after drinking the test nolowmoderate carbohydrate beverages and 2 fluid balance will not differ between the carbohydrate-electrolyte beverages but both will be greater than placebo
In this follow-up study the investigators hypothesize that 1 fluid balance will be sustained greater than or not different from baseline and significantly greater than placebo for 120 min after drinking the test nolowmoderate carbohydrate beverages and 2 fluid balance will not differ between the carbohydrate-electrolyte beverages but both will be greater than placebo
Detailed Description:
This is a two-part study Subjects will be asked to complete either Part 1 or Part 2 of this study Subjects can participate in both parts of the study if they are interested and available to complete all 8 trials However they will be asked to complete Part 1 before enrolling in Part 2 of the study Dosing days are separated by 2-15 days
Objective 1 To compare the effect of consumption of four nolowmoderate carbohydrate drinks with high electrolyte concentrations vs placebo on fluid balance at rest To enroll N25
Objective 2 To compare the effect of consumption of two moderate carbohydrate drinks with low electrolyte concentrations vs placebo on fluid balance at rest To enroll N40
Objective 1 To compare the effect of consumption of four nolowmoderate carbohydrate drinks with high electrolyte concentrations vs placebo on fluid balance at rest To enroll N25
Objective 2 To compare the effect of consumption of two moderate carbohydrate drinks with low electrolyte concentrations vs placebo on fluid balance at rest To enroll N40
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None