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Safflower Oil + Soy Pretzels for Metabolic Syndrome

N/A

Waitlist Available

Led By Yael Vodovotz, Ph.D.

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stated to be postmenopausal and has a cessation of menstruation for greater than 12 months

Agree to consume a standardized vitamin/mineral supplement and avoid other nutrition and alternative supplements for the duration of the study

Must not have

Have an active metabolic or digestive illness including malabsorptive disorders, renal insufficiency, hepatic insufficiency, or had recent (within the year) gastrointestinal surgery

Have a history or have active hormone related diseases of the pituitary, thyroid or pancreas that currently require supplemental hormonal administration thyroid hormones, adrenocorticotropic hormone (ACTH), growth hormone or other endocrine disorders requiring hormone or insulin administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Summary

This trial is testing if a new type of pretzel can help menopausal women maintain a healthy weight. The pretzel contains safflower oil and soy, which may have health benefits. The study requires five visits to the Ohio State University Clinical Research Center.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not specified but may include allergic reactions to ingredients (wheat, soy, safflower oil) if participants have unknown intolerances. Changes in diet could also affect digestion and blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am a woman aged 45-70 and have gone through menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have had cancer before or am currently being treated for cancer.

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I am taking medication to lower my cholesterol.

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I have taken antibiotics for more than a week in the past 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants having Serious and Non-serious Adverse Events.

Number of Participants with 80% Adherence to Safflower Oil Pretzels

Secondary study objectives

Area Under the Concentration-Time Curve for Serum Triglyceride and Glucose

Number of Participants with Improved Satiety Visual Analogue Scale (VAS) with Safflower Oil Pretzel Snacks Compared to Control Pretzels.

Other study objectives

Identify Number of Participants with Changes in Blood Gene Expression from Day 0 Compared to Day 84.

Isoflavone Metabolite Profile Collected from Urine on Days 0, 28, 56, and 84

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Soy-Safflower Oil ArmActive Control1 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 ArmActive Control1 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 InterventionPlacebo Group1 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.

0 / 8Eligibility criteria met