Safflower Oil + Soy Pretzels for Metabolic Syndrome

Recruiting in Palo Alto (17 mi)

Overseen byYael Vodovotz, Ph.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Ohio State University

Trial Summary

What is the purpose of this trial?

This research study is being done to help researchers develop new dietary options for menopausal women to maintain a healthy weight by developing more nutritious snacks that have health benefits. From this study, the researchers hope to gain understanding on how menopausal women with metabolic syndrome digest and absorb foods with safflower oil on its own and when combined with soy. The research team hypothesize that the two different types of pretzels may be processed by your body differently and that components in the pretzel snacks may be helpful for preventing diseases like obesity and cancer. Safflower oil and soybeans contain many natural chemicals that may benefit human health. However, this relationship is not well understood. This study will look at the impact of the pretzel snacks on your blood fat and glucose levels as well as a group of chemicals found in soy called "isoflavones". Isoflavones are natural chemicals found commonly in soybeans or foods made from them. Participants will be screened to determine if they qualify in meeting the study requirements. Participants cannot have a known allergy to dairy, soy, safflower oil, or wheat protein. Also, participants will be asked to stop eating legumes (beans, peas, soy protein, sprouts and peanuts) and to document the oils they eat for the entire 14 weeks of this study. The study will require five visits to the Ohio State University Clinical Research Center (CRC) which part of the Ohio State University's Center for Clinical and Translational Sciences. Once the investigators have determined that you qualify for this study and you decide to participate, you will be consuming three different pretzels each for one month, starting with a control pretzel. After the control pretzel treatment period, you will be randomly assigned (like the "flip of a coin") to start with one of the two pretzel groups (wheat or soy pretzel with safflower oil) for your first treatment period and then switch to the other safflower oil pretzel at your second treatment period.

Research Team

Yael Vodovotz, Ph.D.

Principal Investigator

Ohio State University

Eligibility Criteria

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.

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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.

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Treatment Details

Interventions

Functional Snack Foods (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

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.