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NCT02199054 · ClinicalTrials.gov registry record · NA
Functional Snack Foods With Safflower Oil and Soy in Postmenopausal Women Having Metabolic Syndrome
A NA study, sponsored by Ohio State University.
- Active
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT02199054: Active NA study, sponsored by Ohio State University.
NCT02199054 is a NA study that is active but no longer recruiting, run by Ohio State University. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02199054, a NA study, is active but no longer recruiting, sponsored by Ohio State University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
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 o
Primary Outcome
Standardized qualitative and quantitative toxicity criteria (NIH) will be employed to evaluate safety and toxicity of daily safflower oil consumption.
Interventions
- OTHER wheat-safflower oil pretzels
- OTHER soy-safflower oil pretzels
- OTHER control wheat pretzels
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-07 |
| Est. Completion | 2027-04-10 |
| Phase | NA |
What the registry record for NCT02199054 still lists
NCT02199054 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which wheat-safflower oil pretzels is the first listed.
NCT02199054 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02199054 about?
NCT02199054 is a clinical study titled "Functional Snack Foods With Safflower Oil and Soy in Postmenopausal Women Having Metabolic Syndrome". 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 syndr...
What is the current status of trial NCT02199054?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2014-07. Estimated completion is 2027-04-10.
What interventions are being tested in trial NCT02199054?
The interventions under investigation include: wheat-safflower oil pretzels (OTHER), soy-safflower oil pretzels (OTHER), control wheat pretzels (OTHER).
Who is sponsoring clinical trial NCT02199054?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02199054's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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