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

PRIMARY OBJECTIVES:

I. Assess alterations in chronic inflammatory markers with soft soy pretzel (SSP) intervention among individuals with obesity.

II. Define immune cell populations in obese individuals with SSP intervention.

OUTLINE: Patients with a body mass index (BMI) ≥ 30 and C-reactive protein (CRP) ≥ 0.06 mg/dL are randomized to 1 of 2 arms. Patients with BMI 18.5-24.9 and detectable CRP are assigned to arm III.

ARM I: Patients consume 8 SSP bites twice daily (BID) for 14 days (days 1-14) and then begin a two-week washout period (days 15-28). Following the washout period, patients consume wheat pretzel (WP) bites BID for 14 days (days 28-42). Patients also undergo collection of blood and urine samples on study.

ARM II: Patients consume 8 WP bites BID for 14 days (days 1-14) and then begin a two-week washout period (days 15-28). Following the washout period, patients consume SSP bites BID for 14 days (days 28-42). Patients also undergo collection of blood and urine samples on study.

ARM III: Assigned to Arm I.

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