Dietary Changes Due to Health Claims Messaging

Overseen By Jo-Ann Stebbing, MSC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Boniface Hospital

Disqualifiers: Flaxseed allergy, Pregnant, Lactating, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

384 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to observe changes in dietary habits when participants hear health claims about flaxseed. Participants will incorporate 40g of flaxseed into their daily routine for two weeks, helping researchers understand the impact of health messages on diet. It suits individuals in the Winnipeg area who do not already consume much flaxseed and are willing to try it. As an unphased study, this trial allows participants to contribute to valuable research on dietary habits and health communication.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that incorporating flaxseed into the diet is safe?

Research shows that flaxseed, the treatment under study, is generally safe for people. Available safety information indicates that flaxseed is not harmful and does not cause skin or eye irritation. Studies have not reported any toxic effects or sudden, severe reactions.

Although specific data on sudden toxicity is lacking, flaxseed's widespread use as a food suggests it is well-tolerated. Most studies focus on flaxseed oil, which shares a similar safety profile with the whole seed. Participants should consult a healthcare provider before changing their diet, especially when involved in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using flaxseed as a treatment due to its potential health benefits that stand apart from conventional options. Unlike many standard treatments that involve medications or supplements, incorporating flaxseed emphasizes a natural dietary change. Flaxseed is rich in omega-3 fatty acids, lignans, and fiber, which may offer unique benefits for heart health, digestion, and inflammation reduction. This approach not only targets the condition through a nutritional angle but also promotes overall well-being, making it an appealing alternative or complement to traditional therapies.

What evidence suggests that incorporating flaxseed into the diet could be effective for dietary changes?

Research shows that flaxseed, which participants in this trial will incorporate into their diet, offers several health benefits. Studies have found that it can aid in weight management, lower cholesterol, and reduce blood pressure. Consuming flaxseed is also linked to the prevention and management of conditions such as heart disease, diabetes, and obesity. Its properties help reduce inflammation in the body. Overall, flaxseed supports better health through these effects. ^{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 survey is for men and women over 18 living in the Winnipeg area who are willing to change their diet based on health messages. They must not eat more than 40g of flaxseed daily, be part of another food trial, or have a household member in this study. Pregnant/lactating individuals or those allergic to flaxseed can't join.

Inclusion Criteria

Willing to provide informed consent

Have a mailing address in the Winnipeg census metropolitan area (City of Winnipeg and the municipalities of West St. Paul, East St. Paul, Headingley, Macdonald, Richot, Tache, Springfield, Rosser, St. Francois Xavier and St. Clements)

Willing/able to comply with the requirements of the study

Exclusion Criteria

Allergy, aversion or unwillingness to eat whole ground flaxseed

Pregnant or lactating

Currently participating in a food trial or dietary program that does not allow change in food choice

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants prepare a 3-day food record representative of their current dietary intake

1 week

Remote communication

Dietary Intervention

Participants modify their diet to achieve 40g per day of flaxseeds for 2 weeks

2 weeks

Remote communication

Follow-up

Participants prepare another 3-day food record to assess dietary changes and complete a questionnaire on barriers to implementation

1 week

Remote communication

What Are the Treatments Tested in This Trial?

Interventions

• Flaxseed

Trial Overview The survey investigates how people might alter their eating habits when they receive messages about the health benefits of including flaxseed in their diets.

How Is the Trial Designed?

Group I: Implementation of health claim Experimental Treatment 1 Intervention

Participants will have 2 weeks to incorporate 40g of flaxseed per day into their diet

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

Feeding flaxseed to pregnant rats resulted in reproductive changes in their offspring, including hormonal effects and altered puberty timing, indicating potential estrogenic effects, especially with a 10% flaxseed diet.

Conversely, a 5% flaxseed diet showed antiestrogenic effects, delaying puberty and reducing ovarian weight, suggesting that the lignans in flaxseed can have both estrogenic and antiestrogenic properties depending on the amount consumed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flaxseed and its lignan precursor, secoisolariciresinol diglycoside, affect pregnancy outcome and reproductive development in rats. Tou, JC., Chen, J., Thompson, LU.[2018]

Linum usitatissimum, or flax, has a wide range of pharmacological properties, including antioxidant, anti-inflammatory, and anti-tumor effects, which have been supported by numerous studies, particularly in animal models.

Despite the promising benefits of flax in treating various diseases such as cardiovascular and gastrointestinal disorders, there is a lack of sufficient clinical trials to confirm its efficacy in humans, highlighting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review on Pharmacological and Clinical Aspects of Linum usitatissimum L. Ansari, R., Zarshenas, MM., Dadbakhsh, AH.[2020]

Early exposure to a diet containing 10% flaxseed during lactation reduced bone strength in male rats at postnatal day 50, but this effect was not sustained into early adulthood, indicating a temporary impact on bone health.

The lignan component of flaxseed did not appear to be responsible for the observed reduction in bone strength, as similar exposure to the equivalent amount of lignan did not affect bone measures, suggesting that flaxseed consumption is safe for bone health in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure to flaxseed and its purified lignan reduces bone strength in young but not older male rats. Ward, WE., Yuan, YV., Cheung, AM., et al.[2016]

Adequate intake of dietary fiber, particularly from flaxseed, is associated with a reduced risk of colorectal cancer, highlighting its potential role in cancer prevention.

Flaxseed is a significant source of the anticancer compound secoisolariciresinol diglycoside (SDG), and both the European Food Safety Authority (EFSA) and the US Food and Drug Administration (FDA) recognize its potential benefits in dietary supplementation for cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The legitimacy of using dietary supplement diglycoside secoisolariciresinol (SDG) from flaxseed in cancer. Dobrowolska, K., Regulska-Ilow, B.[2021]

In a study involving 75 overweight adolescents over 11 weeks, both brown and golden flaxseed significantly reduced diastolic blood pressure compared to a control group consuming wheat bran.

However, neither type of flaxseed showed a significant impact on lipid profiles, blood glucose levels, or inflammatory markers, suggesting that the amount consumed may have been insufficient to achieve the expected health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of brown and golden flaxseed on the lipid profile, glycemia, inflammatory biomarkers, blood pressure and body composition in overweight adolescents. Machado, AM., de Paula, H., Cardoso, LD., et al.[2022]

Flaxseed is a powerful source of omega-3 fatty acids, lignans, and fiber, which contribute to its anti-inflammatory, antioxidant, and lipid-modulating properties, benefiting both animal and human health.

Current evidence suggests that dietary flaxseed may positively impact cardiovascular diseases, cancer, gastrointestinal health, brain development, and hormonal balance in menopausal women, highlighting its potential as a functional food for various health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Flaxseed as a Strategy for Improving Human Health. Parikh, M., Maddaford, TG., Austria, JA., et al.[2023]

Flaxseed is a rich source of lignans, particularly secoisolariciresinol diglycoside, which have phytoestrogen properties that may help reduce the risk of hormone-dependent cancers such as breast, uterus, and prostate cancers.

The lignans in flaxseed, specifically enterodiol and enterolactone, exhibit strong antioxidant activity, surpassing that of vitamin E, and have demonstrated anticancer effects in various studies, supporting their use for prevention and treatment of hormone-related tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Phytoestrogenis properties of flaxseed lignans]. Martinchik, AN., Zubtsov, VV.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12181604/

Dietary flaxseed: Cardiometabolic benefits and its role in ... Flaxseed supplementation significantly improves several cardiometabolic risk factors, including body weight, body mass index, lipid levels, blood pressure, ...

2. journals.lww.com journals.lww.com/aptb/fulltext/2023/13070/role_of_flaxseed__linum_usitatissimum_l___in.1.aspx

Role of flaxseed (Linum usitatissimum L.) in disease... Consumption of flaxseeds helps in prevention and control of cardiovascular disease, neurodegenerative disorders, obesity, diabetes mellitus, polycystic ovary ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10353157/

A comprehensive review of the health benefits of flaxseed oil ... Flaxseed oil, fibers, and lignans exert potential health benefits including reduction of cardiovascular disease, atherosclerosis, diabetes, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322004471

Effects of Flaxseed Interventions on Circulating ... According to this meta-analysis, flaxseed significantly reduced circulating concentrations of hs-CRP and TNFα, but did not affect IL6 and CRP.

5. researchgate.net researchgate.net/publication/374439066_Pharmacological_nutritional_and_nutritional_properties_of_flaxseed_Linum_usitatissimum_An_insight_into_its_functionality_and_disease_mitigation

An insight into its functionality and disease mitigation Flaxseed consumption (Linum usitatissimum L.) has increased due to its potential health benefits, such as protection against inflammation, diabetes, cancer ...

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

Safety Data Sheet - Organic Flax Seed Oil a) No toxic data recorded. No data available for acute toxicity. No data found in literature search. b) Skin corrosion / irritation No data available for adult ...

7. avenalab.com avenalab.com/images/001SDS/FLAX-SEED-OIL-SDS-ENG.pdf

FLAX SEED OIL SDS ENG Individual protection measures, such as personal protective equipment. Eye/face protection: Wear safety glasses with side shields (or goggles). Skin protection.

8. nhrorganicoils.com nhrorganicoils.com/uploads/20221206124718e_Flax_SDS.pdf

Safety Data Sheet Organic Flax Seed / Linseed Oil (Linum ... The product is not dangerous, but hot oil may cause burns, and spills can cause slippage. It may form ignitable mixtures and produce smoke and oxides of carbon ...

9. sigmaaldrich.com sigmaaldrich.com/AU/en/sds/aldrich/430021?srsltid=AfmBOoqnEvnSsm-F5KLi9F0hPcrC-clKvKGpxLeKBMMv4z1KGNfF4hkS&srsltid=AfmBOoo0EsylpQ1JxmF4Z3cPP_cXyuDJ6b7I-4zLuJX7Bg1Z-4gr4xk6

SAFETY DATA SHEET Oil dries by oxygen. Rags or waste soaked with oil may spontaneously catch fire if improperly discarded. For precautions see section 2.2. 7.2 ...

10. newdirectionsaromatics.com newdirectionsaromatics.com/msds/MSDS_FlaxseedOrganicCarrierOil.pdf

SAFETY DATA SHEET (SDS) Not classified as dangerous goods. Not expected to be an irritant to skin or eyes. Avoid direct lighting and smoking. Wash hands before eating/ ...