A Dietary Intervention (Soy Soft Pretzels) for Reducing Chronic Inflammation in Obese Individuals
Running, not enrolling · Not applicable
Conditions studied: Colorectal Carcinoma, Obesity-Related Malignant Neoplasm
In brief
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.
Key facts
- Study ID
- NCT07650409
- Run by
- Ohio State University Comprehensive Cancer Center
- People needed
- 30
- Starts
- 2025-06-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-06-16
Who can join
Age: 18 and older, up to 49. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- Inability to comply with all study procedures, lifestyle considerations, and availability for the duration of the study
- Known allergy or intolerance to soy, wheat, or any other ingredients in study intervention
- Current or prior history of type 2 diabetes mellitus as defined by International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) E11
- Current or prior history of cancer (excluding non-melanoma skin cancers)
- History of blood clotting disorders or adverse events relating to blood draws
- Use of antibiotic regime lasting longer than one week within the last six months
- Current enrollment in other research studies for weight loss
- Actively trying to lose weight and/or use of medications for weight loss within the last three months
- Strict veganism (no consumption of animal, fish, or egg products)
- Heavy alcohol consumption (defined as consumption of > 14 drinks/week on average)
- 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
Where it is running
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.