Effect of Flax in Yogurt on Blood Cyanide Levels

November 26, 2024 updated by: Dr. Heather Blewett, St. Boniface Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • I. H. Asper Clinical Research Institute
        • Contact:
        • Contact:
          • Heather J Blewett, PhD
        • Contact:
          • Véronique J Barthet, PhD
        • Contact:
          • Michel Aliani, PhD
        • Contact:
          • Lovemore Malunga, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Generally healthy adult, 18 years or older;
  2. Willing to provide informed consent;
  3. Willing/able to comply with the requirements of the study.

Exclusion Criteria:

  1. Pregnant or lactating;
  2. Medical history of disease that is currently under treatment;
  3. Active treatment for any type of cancer within 1 year prior to study start;
  4. Presence of a gastrointestinal disorder, daily use of any stomach acid-lowering medications or laxatives (including fibre supplements) within the past month or antibiotic use within the past 6 weeks;
  5. Plasma concentration of vitamin B12 < 148 pmol/L;
  6. Complete blood count outside normal range;
  7. Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥3 times the upper limit of normal (ULN));
  8. Fasting blood glucose ≥6.1 mmol/L and/or HbA1c ≥6.0%;
  9. Fasting plasma total cholesterol >7.8 mmol/L;
  10. Fasting plasma HDL <0.9 mmol/L;
  11. Fasting plasma LDL >5.0 mmol/L;
  12. Fasting plasma triglycerides >2.3 mmol/L;
  13. Systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg;
  14. Major surgery within the last 3 months;
  15. Smoking, use of tobacco, vape or cannabis (within the last week);
  16. Allergies to flaxseed or yogurt;
  17. Aversion or unwillingness to eat study foods;
  18. Participation in another clinical trial, current or in the past 4 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: No Flax Product
175 g yogurt containing no flax product
Dietary supplement: 0 g Flax
175 g yogurt with no flax product
Experimental: 40 g whole ground flaxseed
175 g yogurt with 40 g whole ground flaxseed
Dietary supplement: 40 g whole ground flaxseed
175 g yogurt with 40 g whole ground flaxseed
Experimental: 40 g roasted then ground whole 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 roasted then ground whole flaxseed
Experimental: 40 g of whole intact flaxseeds
175 g yogurt with 40 g of whole intact flaxseeds
Dietary supplement: 40 g of whole intact flaxseeds
175 g yogurt with 40 g of whole intact flaxseeds
Experimental: 28 g flax hulls
175 g yogurt with 28 g flax hulls
Dietary supplement: 28 g flax hulls
175 g yogurt with 28 g flax hulls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak blood level of cyanide
Time Frame: 180 minutes
highest concentration of cyanide during 180 min postprandial period
180 minutes
iAUC blood cyanide
Time Frame: 180 min
incremental area under the curve for cyanide from 0-180 min
180 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Cyanogenic glycoside and thiocyanate concentrations in plasma and urine
Time Frame: 180 minutes
180 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of metabolites in blood and urine
Time Frame: 180 minutes
Identification and concentration of metabolites in plasma and urine determined by LC-QTOF-MS
180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Boniface Hospital

Collaborators

Agriculture and Agri-Food Canada

Investigators

  • Principal Investigator: Heather Blewett, PhD, Agriculture and Agri-Food Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 16, 2025

Primary Completion (Estimated)

March 28, 2025

Study Completion (Estimated)

March 28, 2026

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

July 5, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4030/4687

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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