12 Participants Needed

Flaxseed in Yogurt for Healthy Subjects

HB
Overseen ByHeather Blewett, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

What data supports the effectiveness of the treatment Flax in the clinical trial 'Flaxseed in Yogurt for Healthy Subjects'?

Research shows that flaxseed can lower cholesterol levels and improve heart health in people with mild signs of heart disease. It also helps reduce inflammation and improve the balance of fats in the blood, which can be beneficial for overall health.12345

Is flaxseed safe for human consumption?

Flaxseed is generally considered safe for human consumption, as it has been studied for various conditions like cholesterol management, constipation, and weight management without significant safety concerns reported.12678

How does flaxseed in yogurt differ from other treatments for health improvement?

Flaxseed in yogurt is unique because it combines the nutritional benefits of flaxseed, such as high omega-3 fatty acids and dietary fiber, with the probiotic properties of yogurt, potentially improving heart health and glycemic control. This combination offers a novel approach to enhancing yogurt's health benefits, unlike standard yogurt or flaxseed supplements alone.910111213

What is the purpose of this trial?

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.

Research Team

HB

Heather Blewett, PhD

Principal Investigator

Agriculture and Agri-Food Canada

Eligibility Criteria

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 use stomach acid-lowering meds or laxatives daily, or took antibiotics in the last 6 weeks.
See 15 more

Timeline

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

Treatment Details

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.
Participant Groups
5Treatment groups
Experimental Treatment
Group I: No Flax ProductExperimental Treatment1 Intervention
175 g yogurt containing no flax product
Group II: 40 g whole ground flaxseedExperimental Treatment1 Intervention
175 g yogurt with 40 g whole ground flaxseed
Group III: 40 g roasted then ground whole flaxseedExperimental Treatment1 Intervention
175 g yogurt with 40 g roasted then ground whole flaxseed
Group IV: 40 g of whole intact flaxseedsExperimental Treatment1 Intervention
175 g yogurt with 40 g of whole intact flaxseeds
Group V: 28 g flax hullsExperimental Treatment1 Intervention
175 g yogurt with 28 g flax hulls

Find a Clinic Near You

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+

Findings from Research

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.
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]

References

Dietary flaxseed independently lowers circulating cholesterol and lowers it beyond the effects of cholesterol-lowering medications alone in patients with peripheral artery disease. [2023]
Effect of flaxseed supplementation on markers of inflammation and endothelial function: A systematic review and meta-analysis. [2021]
Brown and golden flaxseed reduce intestinal permeability and endotoxemia, and improve the lipid profile in perimenopausal overweight women. [2022]
Comparisons of the effects of different flaxseed products consumption on lipid profiles, inflammatory cytokines and anthropometric indices in patients with dyslipidemia related diseases: systematic review and a dose-response meta-analysis of randomized controlled trials. [2021]
Effect of milled flaxseed and storage conditions on sensory properties and selected bioactive compounds in banana and cinnamon muffins used in a clinical trial. [2019]
Flax and flaxseed oil (Linum usitatissimum): a review by the Natural Standard Research Collaboration. [2022]
Dual effectiveness of Flaxseed in constipation and diarrhea: Possible mechanism. [2022]
The effect of flaxseed supplementation on body weight and body composition: a systematic review and meta-analysis of 45 randomized placebo-controlled trials. [2022]
Effect of flaxseed oil and flour on sensory, physicochemical and fatty acid profile of the fruit yoghurt. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Texture and sensory characterization of functional yogurt supplemented with flaxseed during cold storage. [2023]
11.Korea (South)pubmed.ncbi.nlm.nih.gov
The Effect of Flaxseed Enriched Yogurt on the Glycemic Status and Cardiovascular Risk Factors in Patients with Type 2 Diabetes Mellitus: Randomized, Open-labeled, Controlled Study. [2022]
Effect of the Addition of Whole and Milled Flaxseed on the Quality Characteristics of Yogurt. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
Health lipid indices and physicochemical properties of dual fortified yogurt with extruded flaxseed omega fatty acids and fibers for hypercholesterolemic subjects. [2020]
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