NCT06491095

Effect of Flax in Yogurt on Blood Cyanide Levels

A Randomized, Controlled, Cross-over Trial Examining the Effect of Flaxseed on Blood Cyanide Levels in Healthy Adults

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: St. Boniface Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	0 g Flax	175 g yogurt with no flax product
DIETARY_SUPPLEMENT	40 g whole ground flaxseed	175 g yogurt with 40 g whole ground flaxseed
DIETARY_SUPPLEMENT	40 g roasted then ground whole flaxseed	175 g yogurt with 40 g roasted then ground whole flaxseed
DIETARY_SUPPLEMENT	40 g of whole intact flaxseeds	175 g yogurt with 40 g of whole intact flaxseeds
DIETARY_SUPPLEMENT	28 g flax hulls	175 g yogurt with 28 g flax hulls

Timeline

• Start date: 2025-01-16
• Primary completion: 2025-03-28
• Completion: 2026-03-28
• First posted: 2024-07-08
• Last updated: 2024-12-02

Locations

1 site across 1 country: Canada