Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-03 @ 11:32 PM
Study NCT ID:
NCT06491095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-02
First Post:
2024-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Flax in Yogurt on Blood Cyanide Levels
Sponsor:
St. Boniface Hospital
Organization:
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:
2024-11
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:
False
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?:
False
Is an FDA AA801 Violation?: