Flaxseed in Yogurt for Healthy Subjects

Overseen By Heather Blewett, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Boniface Hospital

Must not be taking: Stomach acid-lowering, Laxatives, Antibiotics

Disqualifiers: Pregnancy, Cancer, Liver disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of flaxseed mixed with yogurt affect blood cyanide levels in healthy individuals. Participants will consume yogurt with various forms of flaxseed, such as whole, ground, or roasted, to determine any differences in blood levels after consumption. It suits those who are generally healthy, have no current medical conditions under treatment, and are comfortable eating yogurt and flaxseed. As an unphased trial, this study allows participants to contribute to nutritional science and understand how diet can impact health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using stomach acid-lowering medications, laxatives, or antibiotics within certain time frames before the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that flaxseed is generally safe for most adults when consumed in normal amounts. Studies indicate that eating whole ground flaxseed, whole flaxseeds, or roasted ground flaxseed can lead to more frequent bowel movements, a common and mild side effect. Concerns about cyanide poisoning are minimal, as harmful effects would require consuming about 8 cups of ground flaxseed, far more than typical consumption.

Regarding flax hulls, research has found no negative effects when used as a supplement. Flax hull lignans, compounds in the hulls, are considered safe and did not cause any negative side effects in studies. Overall, all forms of flaxseed under study—ground, whole, roasted, and hulls—are well-tolerated by humans in reasonable amounts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these flaxseed-enhanced yogurt treatments because they offer a potential natural way to boost health with minimal side effects. Flaxseeds are packed with omega-3 fatty acids, fiber, and lignans, which are not typically found in standard probiotic yogurt. Unlike conventional yogurts, adding whole, ground, or roasted flaxseeds, as well as flax hulls, could provide additional nutritional benefits, supporting heart health and digestion. This approach is particularly appealing because it combines the familiar probiotic benefits of yogurt with the unique nutrient profile of flaxseed, potentially offering a more holistic health boost.

What evidence suggests that this trial's treatments could be effective for reducing blood cyanide levels?

This trial will compare different forms of flaxseed incorporated into yogurt. Research has shown that flaxseed, in various forms, offers several health benefits. Participants may receive yogurt with ground flaxseed, which can help lower cholesterol and blood pressure, improve digestion, and reduce the risk of some cancers. Others may receive yogurt with whole flaxseeds, which provide similar benefits, including high fiber and omega-3 fatty acids that support heart health. Yogurt with roasted and ground flaxseed is another option, known to aid in blood sugar control and cholesterol management. Additionally, some participants will receive yogurt with flax hulls, rich in lignans that help balance hormones and may protect against cancer and heart disease. Overall, flaxseed is nutrient-rich and supports overall health. ^{6 7 8 9 10}

Who Is on the Research Team?

Heather Blewett, PhD

Principal Investigator

Agriculture and Agri-Food Canada

Are You a Good Fit for This Trial?

This trial is for healthy individuals who are interested in participating in a study to understand how different forms of flaxseed mixed with yogurt affect blood cyanide levels. Specific eligibility criteria details were not provided.

Inclusion Criteria

Willing to provide informed consent

Willing/able to comply with the requirements of the study

Exclusion Criteria

Plasma concentration of vitamin B12 < 148 pmol/L

Allergies to flaxseed or yogurt

I am currently being treated for a medical condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants consume yogurt with different flaxseed products, and blood and urine samples are collected at specified intervals

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Flax

Trial Overview The trial is testing the effects of various flaxseed preparations on blood cyanide levels when consumed with yogurt. Participants will try different types including whole ground, roasted then ground, intact seeds, and hulls only.

How Is the Trial Designed?

Group I: No Flax Product Experimental Treatment 1 Intervention

175 g yogurt containing no flax product

Group II: 40 g whole ground flaxseed Experimental Treatment 1 Intervention

175 g yogurt with 40 g whole ground flaxseed

Group III: 40 g roasted then ground whole flaxseed Experimental Treatment 1 Intervention

175 g yogurt with 40 g roasted then ground whole flaxseed

Group IV: 40 g of whole intact flaxseeds Experimental Treatment 1 Intervention

175 g yogurt with 40 g of whole intact flaxseeds

Group V: 28 g flax hulls Experimental Treatment 1 Intervention

175 g yogurt with 28 g flax hulls

Who Is Running the Clinical Trial?

St. Boniface Hospital

Lead Sponsor

Trials

55

Recruited

15,000+

Agriculture and Agri-Food Canada

Collaborator

Trials

35

Recruited

2,300+

Published Research Related to This Trial

Flaxseed supplementation was found to significantly reduce levels of inflammatory markers such as C-reactive protein (CRP), interleukin-6 (IL-6), and vascular cell adhesion protein 1 (VCAM-1) in a meta-analysis of 40 randomized controlled trials involving 2520 participants.

Despite these positive effects on certain inflammatory markers, flaxseed did not show a significant impact on other markers like tumor necrosis factor-alpha (TNF-α), intercellular adhesion molecule 1 (ICAM-1), and E-selectin, indicating that further well-designed studies are needed to clarify these mixed results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of flaxseed supplementation on markers of inflammation and endothelial function: A systematic review and meta-analysis. Askarpour, M., Karimi, M., Hadi, A., et al.[2021]

Citations

1. healthline.com healthline.com/nutrition/benefits-of-flaxseeds

8 Flaxseed Health Benefits, Precautions, How to Eat Them Flaxseed may help lower the risk of some cancers, maintain a moderate weight, and reduce cholesterol and blood pressure.

2. webmd.com webmd.com/diet/features/benefits-of-flaxseed

The Benefits of Flaxseed Is flaxseed the new wonder food? Preliminary studies show that flaxseed may help fight everything from heart disease and diabetes to breast cancer.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6567199/

Dietary Flaxseed as a Strategy for Improving Human Health Flax oil rich in ALA showed a positive effect on bone health, particularly in pathological conditions such as obesity and kidney disease.

4. arthritis.org arthritis.org/health-wellness/healthy-living/nutrition/anti-inflammatory/flaxseed-fight-inflammation

Flaxseeds: Punching Above Their Weight to Fight ... Flaxseed has been shown to protect against cancer and heart disease and to ease symptoms of rheumatoid arthritis, lupus and Raynaud's phenomenon.

5. raphaglobal.com raphaglobal.com/blog/flax-hull-lignans-vs-flax-seed-lignans/?srsltid=AfmBOopy-1kmIR3o_uKJZJ5rYg46LjHe3fyKuLENftOPJ0wvS6afb1LV

Flax Hull Lignans vs Flax Seed Lignans Flax Hull Lignans vs Flax Seed Lignans ... Lignans are excellent for balancing hormone levels in the body. #flax health benefits · #flax lignans ...

6. raphaglobal.com raphaglobal.com/flax-hull-lignans/?srsltid=AfmBOoo5IjkNvkhqd7xebnVdXuVa5hJLgMx3UwiZofmsmILI_v-B-Iiw

Organic Flax Hull Lignans (FHL) Powder (SDG) Flax Hull Lignans powder is a non-GMO, organic plant-based product produced from flaxseed providing 70 to 800 more lignans to help improve overall health.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4517353/

Potential protective properties of flax lignan ... - PubMed Central Flaxseed lignans especially SDG occur in ester-linkage form in the hulls enclosing the seeds, which require special pretreatments including ...

8. botanicinnovations.com botanicinnovations.com/wp-content/uploads/2021/07/SDS_Organic-Flax-Seed-Oil.pdf

Safety Data Sheet - Organic Flax Seed Oil Skin Irritation. Eye Irritation. Specific Target Organ Toxicity – Single Exposure. No hazard, no risk. Unlikely to irritate eyes. Not expected route of exposure ...

9. vetmed.tennessee.edu vetmed.tennessee.edu/wp-content/uploads/sites/4/LIGNANS-INFORMATION.pdf

1) Flax hull (SDG) lignans, derived f HMR lignan contains very little (if any) fiber, so this side effect is not expected with. HMR lignan. Page 2. Safety. No adverse effects to the use of SDG flax ...

10. liebertpub.com liebertpub.com/doi/10.1089/jmf.2013.3129

Efficacy and Safety of a Flaxseed Hull Extract in the ... Treatment with flaxseed hull extract did not lead to adverse effects compared with placebo. Supplementation with flaxseed hull extract was found to be safe and ...