NCT07650409Active, not recruiting
A Dietary Intervention (Soy Soft Pretzels) for Reducing Chronic Inflammation in Obese Individuals
Examining the Efficacy of a Soft Soy Pretzel Intervention in Altering Chronic Inflammation and Immune Profiles in Obese Individuals
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
This clinical trial compares the effects of soy soft pretzels versus wheat pretzels on inflammatory markers in individuals with obesity. Obesity is a serious public health problem that can lead to chronic inflammation, which is associated with many negative health conditions and some types of cancer. Soy versus wheat pretzels may be processed by the body differently, and the components in these pretzel snacks may be helpful for reducing inflammation. Soy soft pretzels are made with soybeans, which contain many natural chemicals that may be beneficial to human health, such as isoflavones. Existing research has suggested that diets enriched with isoflavones may help reduce inflammation. However, the relationship between soy-rich diets and the immune systems of obese individuals is not well understood. This trial may help researchers determine whether soy soft pretzels are useful for lowering markers of chronic inflammation, compared to wheat pretzels, in individuals with obesity.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 10 Jun 2026
- Start date
- 1 Jun 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Diseases
- Obesity, Colorectal cancer
- NCT number
- NCT07650409
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Jun 2025 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or prior history of type 2 diabetes mellitus as defined by International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) E11
- Actively trying to lose weight and/or use of medications for weight loss within the last three months
- Current or prior history of any condition that causes altered immunity such as chronic inflammatory disease, autoimmune disorders, cancer, anemia, and blood dyscrasias
- Regular usage of inflammation lowering medications which include but not limited to nonsteroidal anti-inflammatory drugs such as aspirin, ibuprofen, and naproxen, or anti-pyretic medications such as acetaminophen
Other illness
- Known allergy or intolerance to soy, wheat, or any other ingredients in study intervention
- Current or prior history of cancer (excluding non-melanoma skin cancers)
- History of blood clotting disorders or adverse events relating to blood draws
Other
- Inability to comply with all study procedures, lifestyle considerations, and availability for the duration of the study
- Use of antibiotic regime lasting longer than one week within the last six months
- Current enrollment in other research studies for weight loss
- Strict veganism (no consumption of animal, fish, or egg products)
- Heavy alcohol consumption (defined as consumption of \> 14 drinks/week on average)
Who the study is looking for
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures, lifestyle considerations, and availability for the duration of the study
- Males sex
- 18 and 49 years of age
- Height and weight or calculated BMI for:
- Obese participants must be ≥ 30 kg/m\^2
- Non-obese (healthy) participants must be between 18.5 and 24.9 kg/m\^2
Age in the registry: 18 years to 49 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.