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

Trial Summary

What is the purpose of this trial?

A survey designed to examine how consumers adapt their diet in response to health claim messaging.

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 data supports the effectiveness of the treatment Flaxseed, Linum usitatissimum, for dietary changes due to health claims messaging?

Research indicates that flaxseed, rich in lignans, may reduce the risk of hormone-dependent cancers like breast, uterus, and prostate cancer due to its antioxidant properties. Additionally, flaxseed's fiber content may help lower the risk of colorectal cancer, and its anti-inflammatory properties are beneficial for overall health. ^{1 2 3 4 5}

Is flaxseed generally safe for human consumption?

Flaxseed is generally considered safe for human consumption and is rich in beneficial compounds like omega-3 fatty acids and lignans, which have anti-inflammatory and antioxidant properties. However, some studies suggest that early exposure to flaxseed may affect bone development in young male rats, but this effect was not sustained into adulthood. ^{2 3 4 5 6}

How does the treatment in the 'Dietary Changes Due to Health Claims Messaging' trial differ from other treatments?

This treatment focuses on dietary changes influenced by health claims, which is unique because it emphasizes the role of communication and perception in dietary habits, rather than relying on specific drugs or supplements. Unlike traditional treatments that may involve medication, this approach leverages the psychological impact of health messaging to encourage healthier eating patterns. ^{2 3 5 6 7}

Research Team

Heather Blewett, PhD

Principal Investigator

Agriculture and Agri-Food Canada

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Flaxseed and its lignan precursor, secoisolariciresinol diglycoside, affect pregnancy outcome and reproductive development in rats. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Exposure to flaxseed and its purified lignan reduces bone strength in young but not older male rats. [2016]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

A Review on Pharmacological and Clinical Aspects of Linum usitatissimum L. [2020]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Phytoestrogenis properties of flaxseed lignans]. [2013]

5. Poland pubmed.ncbi.nlm.nih.gov

The legitimacy of using dietary supplement diglycoside secoisolariciresinol (SDG) from flaxseed in cancer. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Flaxseed as a Strategy for Improving Human Health. [2023]

7. United States 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. [2022]