Clinical trial

A Dietary Intervention (Soy Soft Pretzels) for Reducing Chronic Inflammation in Obese Individuals

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07650409

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 49 Years

SexMale

Healthy volunteersAccepted

ConditionColorectal Carcinoma, Obesity-Related Malignant Neoplasm

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Treatments and study arms

Biospecimen Collection

Procedure

Undergo collection of blood and urine samples

Dietary Intervention

Other

Consume SSPs

Dietary Intervention

Other

Consume WPs

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

Differences in chronic inflammatory biomarkersUp to 42 days

Will be compared between interventions using a repeated measures analysis of variance and between obese and normal body mass index groups. Inflammatory biomarker concentrations will be determined by comparing signal intensity of each well to a generated standard curve and averaged to make a single data point per biomarker per individual. Biomarker concentrations will be transformed to prevent heteroskedasticity. Depending on the underlying distribution of the data, Student's t-test or Mann-Whitney U will be used to compare individual biomarker expression values, using Bonferroni correction for multiple comparisons. Immunophenotyping will be analyzed using log-transformed cell counts and comparisons of defined populations between groups, with statistical significance corrected for multiple comparisons.

Differences in percentages of immune cell populationsUp to 42 days

Will be compared between interventions using a repeated measures analysis of variance and between obese and normal body mass index groups. Immune cell population analyses will be visualized using clustering and t-stochastic neighbor embedding plots.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Ohio State University Comprehensive Cancer Center🇺🇸 Columbus, Ohio, United States

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