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

NCT07650409 | Active Not Recruiting DMC

• 2 other identifiers: OSU-25053NCI-2026-01822
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Carcinoma; Obesity-Related Malignant Neoplasm

Outcome Measures

Primary Outcomes (2)

• Differences in chronic inflammatory biomarkers

  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.

  Up to 42 days

• Differences in percentages of immune cell populations

  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.

  Up to 42 days

Study Arms (3)

Arm I (SSP, WP)

EXPERIMENTAL

Patients consume 8 SSP 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 WP bites BID for 14 days (days 28-42). Patients also undergo collection of blood and urine samples on study.

Procedure: Biospecimen Collection; Other: Dietary Intervention; Other: Questionnaire Administration

Arm II (WP, SSP)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Other: Dietary Intervention; Other: Questionnaire Administration

Arm III (WP, SSP)

EXPERIMENTAL

Patients receive intervention as in Arm I. Patients also undergo collection of blood and urine samples on study.

Procedure: Biospecimen Collection; Other: Dietary Intervention; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood and urine samples

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Arm I (SSP, WP); Arm II (WP, SSP); Arm III (WP, SSP)

Dietary Intervention OTHER

Consume SSPs

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Arm I (SSP, WP); Arm II (WP, SSP); Arm III (WP, SSP)

Questionnaire Administration OTHER

Ancillary studies

Arm I (SSP, WP); Arm II (WP, SSP); Arm III (WP, SSP)

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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
• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Ohio Soybean Council: collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Specimen Handling; Diet Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Nutrition Therapy; Therapeutics

Study Officials

• Holli Loomans-Kropp, PhD, MPH

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

US (1)