An interventional study of 0 g Flax and 40 g whole ground flaxseed in Healthy, sponsored by St. Boniface Hospital. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by St. Boniface Hospital · Not applicable, Interventional, and Prevention
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.
Participants will receive yogurt containing the following flaxseed products in a random order:
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.
St. Boniface Hospital is the lead sponsor of 32 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
175 g yogurt containing no flax product
Dietary Supplement: 0 g Flax
175 g yogurt with 40 g whole ground flaxseed
Dietary Supplement: 40 g whole ground flaxseed
175 g yogurt with 40 g roasted then ground whole flaxseed
Dietary Supplement: 40 g roasted then ground whole flaxseed
175 g yogurt with 40 g of whole intact flaxseeds
Dietary Supplement: 40 g of whole intact flaxseeds
175 g yogurt with 28 g flax hulls
Dietary Supplement: 28 g flax hulls
175 g yogurt with no flax product
175 g yogurt with 40 g whole ground flaxseed
175 g yogurt with 40 g roasted then ground whole flaxseed
175 g yogurt with 40 g of whole intact flaxseeds
175 g yogurt with 28 g flax hulls
Peak blood level of cyanide
highest concentration of cyanide during 180 min postprandial period
Time frame: 180 minutes
iAUC blood cyanide
incremental area under the curve for cyanide from 0-180 min
Time frame: 180 min
Cyanogenic glycoside and thiocyanate concentrations in plasma and urine
Time frame: 180 minutes
Concentration of metabolites in blood and urine
Identification and concentration of metabolites in plasma and urine determined by LC-QTOF-MS
Time frame: 180 minutes
Start is estimated for Jan 2025; primary completion for Mar 2025, 2 months later.
How these figures are worked out, and which studies are left out of them.
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St. Boniface Hospital