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NCT Number: NCT06491095

Effect of Flax in Yogurt on Blood Cyanide Levels

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

I. H. Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

Location contact

Heather J Blewett, PhD

CONTACT

[email protected]

204-237-2954

Heather J Blewett, PhD

CONTACT

Lovemore Malunga, PhD

CONTACT

Michel Aliani, PhD

CONTACT

Véronique J Barthet, PhD

CONTACT

About this study

Participants will receive yogurt containing the following flaxseed products in a random order:

  • 40 g ground flaxseed, untreated;
  • 40 g ground flaxseed, roasted before grinding;
  • 40 g intact whole flaxseed;
  • 28 g flaxseed hulls;
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant or lactating;
  • Medical history of disease that is currently under treatment;
  • Active treatment for any type of cancer within 1 year prior to study start;
  • 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;
  • Plasma concentration of vitamin B12 < 148 pmol/L;
  • Complete blood count outside normal range;
  • Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥3 times the upper limit of normal (ULN));
  • Fasting blood glucose ≥6.1 mmol/L and/or HbA1c ≥6.0%;
  • Fasting plasma total cholesterol >7.8 mmol/L;
  • Fasting plasma HDL <0.9 mmol/L;
  • Fasting plasma LDL >5.0 mmol/L;
  • Fasting plasma triglycerides >2.3 mmol/L;
  • Systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg;
  • Major surgery within the last 3 months;
  • Smoking, use of tobacco, vape or cannabis (within the last week);
  • Allergies to flaxseed or yogurt;
  • Aversion or unwillingness to eat study foods;
  • Participation in another clinical trial, current or in the past 4 weeks

Treatment and study plan

0 g Flax

Dietary Supplement

175 g yogurt with no flax product

40 g whole ground flaxseed

Dietary Supplement

175 g yogurt with 40 g whole ground flaxseed

40 g roasted then ground whole flaxseed

Dietary Supplement

175 g yogurt with 40 g roasted then ground whole flaxseed

40 g of whole intact flaxseeds

Dietary Supplement

175 g yogurt with 40 g of whole intact flaxseeds

28 g flax hulls

Dietary Supplement

175 g yogurt with 28 g flax hulls

Primary outcomes

  1. Peak blood level of cyanide

    Time frame: 180 minutes

    highest concentration of cyanide during 180 min postprandial period

  2. iAUC blood cyanide

    Time frame: 180 min

    incremental area under the curve for cyanide from 0-180 min

Secondary outcomes

  1. Cyanogenic glycoside and thiocyanate concentrations in plasma and urine

    Time frame: 180 minutes

Other outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Blewett, PhD

CONTACT

[email protected]

204-237-2954

Sponsors and collaborators

Lead sponsor

St. Boniface Hospital

Other

Collaborators

  • Agriculture and Agri-Food Canada

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 8, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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