Ignite Creation Date:
2024-07-17 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-05
Brief Title:
Effect of Flax in Yogurt on Blood Cyanide Levels
Sponsor:
St Boniface Hospital
Organization:
St Boniface Hospital
Study Overview
Official Title:
A Randomized Controlled Cross-over Trial Examining the Effect of Flaxseed on Blood Cyanide Levels in Healthy Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized controlled cross-over post-prandial trial in healthy human volunteers will be conducted at the IH Asper Institute to determine the effect whole ground flaxseed roasted then ground whole flaxseed whole intact flaxseed and flaxseed hulls mixed into yogurt on blood cyanide levels
Detailed Description:
Participants will receive yogurt containing the following flaxseed products in a random order
1 40 g ground flaxseed untreated
2 40 g ground flaxseed roasted before grinding
3 40 g intact whole flaxseed
4 28 g flaxseed hulls
5 0 g flaxseed
Venous blood will be collected at the following time points 0 before consumption of test product 15 30 45 60 75 90 120 150 180 min
Urine will be collected prior to consumption of test product and 180 min
Primary endpoints 1 Peak blood level of cyanide and incremental area under the curve iAUC for cyanide in blood over a 3h postprandial period Secondary endpoint 1 cyanogenic glycoside and thiocyanate concentrations in plasma and urine over a 3h postprandial period
Tertiary endpoints 1 metabolic profile in plasma and urine over 3 h postprandial period
1 40 g ground flaxseed untreated
2 40 g ground flaxseed roasted before grinding
3 40 g intact whole flaxseed
4 28 g flaxseed hulls
5 0 g flaxseed
Venous blood will be collected at the following time points 0 before consumption of test product 15 30 45 60 75 90 120 150 180 min
Urine will be collected prior to consumption of test product and 180 min
Primary endpoints 1 Peak blood level of cyanide and incremental area under the curve iAUC for cyanide in blood over a 3h postprandial period Secondary endpoint 1 cyanogenic glycoside and thiocyanate concentrations in plasma and urine over a 3h postprandial period
Tertiary endpoints 1 metabolic profile in plasma and urine over 3 h postprandial period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None