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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have not had a menstrual period for over a year and am considered postmenopausal.
Select...
I agree to follow the study's vitamin/mineral plan and not take other supplements.
Select...
I am a woman aged 45-70 and have gone through menopause.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants having Serious and Non-serious Adverse Events.
Number of Participants with 80% Adherence to Safflower Oil Pretzels
Secondary outcome measures
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 outcome measures
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.
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Who is running the clinical trial?
Ohio State UniversityLead Sponsor
829 Previous Clinical Trials
505,723 Total Patients Enrolled
11 Trials studying Metabolic Syndrome
969 Patients Enrolled for Metabolic Syndrome
Yael Vodovotz, Ph.D.Principal InvestigatorOhio State University
1 Previous Clinical Trials
67 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.I have not had a menstrual period for over a year and am considered postmenopausal.I have a condition that affects my immune system, like autoimmune disease or cancer.I have had cancer before or am currently being treated for cancer.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.I meet at least three of the criteria related to waist size, triglycerides, HDL, blood glucose, or blood pressure.You are a strict vegan and do not eat any animal, fish, or egg products.I am a woman aged 45-70 and have gone through menopause.I am taking medication to lower my cholesterol.You drink more than 14 alcoholic drinks per week on average.I have taken antibiotics for more than a week in the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Run-in Intervention
- Group 2: Soy-Safflower Oil Arm
- Group 3: Wheat-Safflower Oil Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research initiative allow patients aged 25 and above to enroll?
"This trial has set 45 years old as their minimum age threshold and 70 years old as their upper limit for enrolment."
Answered by AI
Are there currently any vacancies for participants in this research project?
"Unfortunately, the study listed on clinicaltrials.gov is no longer recruiting participants; it was originally posted in July 2014 and updated lastly in September 2021. Notwithstanding this trial's closure, there are still 1786 other medical trials actively seeking patients at present."
Answered by AI
Which individuals are eligible to partake in this scientific experiment?
"This medical trial seeks 20 postmenopausal individuals, 45-70 years old with metabolic syndrome. To qualify for this study, patients must have a body mass index over 25kg/m2 and a waist circumference larger than 35 inches. Furthermore, they must meet three of the five following criteria: 12 as well as pledge to consume only standardized vitamin/mineral supplements and abnegate other nutrition or alternative supplementation during their participation in this experiment."
Answered by AI
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