Safflower Oil + Soy Pretzels for Metabolic Syndrome

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Cholesterol medications

Disqualifiers: Metabolic illness, Hormone diseases, Cancer, others

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how certain snacks can help menopausal women manage weight and health. Researchers seek to determine if pretzels made with safflower oil and soy can positively affect blood fat and glucose levels, potentially preventing conditions like obesity and cancer. Participants will try different types of pretzels over 14 weeks. This trial suits postmenopausal women who have experienced metabolic syndrome symptoms, such as a waist greater than 35 inches or high blood sugar.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve health outcomes for menopausal women.

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 on cholesterol-lowering medications or certain hormone treatments. You will also need to avoid legumes and certain supplements during the study.

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

Research has shown that using safflower oil and soy together may reduce inflammation and improve heart health. Studies on plant-based diets high in soy protein and safflower-seed oil have demonstrated benefits for reducing inflammation and boosting the immune system. One study found that safflower oil improved certain health markers in animals, which is promising for humans. However, excessive use of safflower oil might cause problems, so moderation is important.

For the soy-safflower oil pretzels, research suggests they might help protect against risks related to metabolic syndrome and heart disease. No specific reports of negative effects have emerged, indicating that the ingredients are generally safe.

Overall, based on these studies, the ingredients in the pretzels appear safe and may offer health benefits. However, it is important to follow the trial guidelines and report any concerns during the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatment approaches for metabolic syndrome because they incorporate functional snack foods, which is a novel way to address this condition. Unlike standard treatments that often involve medication or more restrictive dietary changes, these treatments use soy-safflower oil and wheat-safflower oil pretzel bites to deliver beneficial nutrients. The unique feature is the inclusion of safflower oil, known for its potential benefits in regulating metabolic health. This approach not only targets metabolic syndrome in a more natural and enjoyable manner but also provides an innovative way to integrate therapeutic components into everyday snacking habits.

What evidence suggests that this trial's treatments could be effective for metabolic syndrome?

Research has shown that safflower oil and soybeans contain natural substances that may benefit health. Studies suggest these ingredients could protect against metabolic syndrome and reduce heart disease risk. Safflower oil, in particular, helps manage cholesterol and improve blood fat levels. When combined with soy, these benefits might increase because soy contains isoflavones, which support heart health. This trial will explore the combination of safflower oil and soy in pretzels. Participants in the Soy-Safflower Oil Arm will consume soy-safflower oil pretzel bites, while those in the Wheat-Safflower Oil Arm will consume wheat-safflower oil pretzel bites. The study aims to determine if these combinations can improve health outcomes for menopausal women with metabolic syndrome. ^{1 2 3 6 7}

Who Is on the Research Team?

Yael Vodovotz, Ph.D.

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for postmenopausal women aged 45-70 with a BMI ≥25 and metabolic syndrome, willing to take a vitamin supplement and avoid legumes. They must not be strict vegans, have certain hormonal or digestive diseases, heavy alcohol consumption, altered immunity conditions like autoimmune disorders or cancer, recent weight loss treatments or antibiotics.

Inclusion Criteria

I have not had a menstrual period for over a year and am considered postmenopausal.

You weigh more than what is considered healthy for your height.

I agree to follow the study's vitamin/mineral plan and not take other supplements.

Exclusion Criteria

I have a current issue with my metabolism, digestion, kidneys, liver, or had recent gut surgery.

I have a hormone-related condition affecting my pituitary, thyroid, or pancreas that requires hormone supplements.

I am not currently in a weight loss study or taking new weight loss drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Run-in

Participants consume control wheat pretzels with a flavored oil dip and maintain a legume-free diet

4 weeks

1 visit (in-person)

Treatment

Participants consume either soy-safflower oil or wheat-safflower oil pretzels, switching after 4 weeks

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Functional Snack Foods

Trial Overview The study tests the effects of wheat-safflower oil pretzels and soy-safflower oil pretzels against control wheat pretzels on blood fat and glucose levels in menopausal women with metabolic syndrome. Participants will try each type of pretzel for one month to see how their bodies process them.

How Is the Trial Designed?

Group I: Soy-Safflower Oil Arm Active Control 1 Intervention

Soy-safflower oil pretzel bites (12 pieces total) will be consumed with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids) at the start of a 7 hour clinic visit as well as 6 pieces of soy-safflower oil pretzels will be eaten twice a day (total of 12 pieces/day) for 28 days. During these 28 days, participants will monitor their oil consumption and maintain a legume-free diet.

Group II: Wheat-Safflower Oil Arm Active Control 1 Intervention

Wheat-safflower oil pretzel bites (12 pieces total) will be consumed with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids) at the start of a 7 hour clinic visit as well as 6 pieces of wheat-safflower oil pretzels will be eaten twice a day (total of 12 pieces/day) for 28 days. During these 28 days, participants will monitor their oil consumption and maintain a legume-free diet.

Group III: Run-in Intervention Placebo Group 1 Intervention

Control wheat pretzel bites (12 pieces total) will be consumed with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids) at the start of a 7 hour clinic visit as well as 6 pieces of control wheat pretzels will be eaten twice a day (total of 12 pieces/day) for 28 days. During these 28 days, participants will monitor their oil consumption and maintain a legume-free diet.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02199054

Functional Snack Foods With Safflower Oil and Soy in ... The primary objective is to evaluate safflower oil delivered in a wheat pretzel compared to a wheat pretzel enhanced with soy will have a greater affect on ...

2. etd.ohiolink.edu etd.ohiolink.edu/acprod/odb_etd/ws/send_file/send?accession=osu1429190003&disposition=inline

The Effect of Safflower oil-Containing Soy Snack Pretzels ... Are Protective Against Metabolic Syndrome and Cardiovascular Disease Risk Factors. ... Vascular Disease Pathophysiology, Clinical Consequences, and Medical ...

3. clinicaltrial.be clinicaltrial.be/en/details/11726?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Functional Snack Foods with Safflower Oil and Soy in Post... The impact of safflower oil pretzels with and without soy on snacking behavior and satiety will be measured by comparing visual analogue scale ...

4. withpower.com withpower.com/clinical-trials/for-metabolic-syndrome?new=true&page=1

Top Metabolic Syndrome Clinical Trials | Power Safflower oil and soybeans contain many natural chemicals that may benefit human health. However, this relationship is not well understood. This study will look ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6669947/

Diets Low in Saturated Fat with Different Unsaturated Fatty ... The 5 diets increased serum-mediated cholesterol efflux capacity from THP-1 macrophages similarly by 39%, 34%, 55%, 49% and 51%, respectively, compared with ...

6. health.clevelandclinic.org health.clevelandclinic.org/seed-oils-are-they-actually-toxic

Seed Oils: Are They Actually Toxic? Seed oils are chemically processed, high in omega-6 fats, and linked to inflammation, but the main concern is their use in processed foods, not ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11641560/

Soy Protein and Safflower-Seed Oil Attenuate Inflammation ... A plant-based diet rich in soy protein and safflower-seed oil may help manage HUA and associated inflammation and immune dysfunction.