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

June 10, 2026 updated by: Holli Loomans-Kropp, Ohio State University Comprehensive Cancer Center

Examining the Efficacy of a Soft Soy Pretzel Intervention in Altering Chronic Inflammation and Immune Profiles in Obese Individuals

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (SSP, WP)
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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo collection of blood and urine samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Other: Dietary Intervention
Consume SSPs
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions
Other: Dietary Intervention
Consume WPs
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions
Experimental: Arm II (WP, SSP)
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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo collection of blood and urine samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Other: Dietary Intervention
Consume SSPs
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions
Other: Dietary Intervention
Consume WPs
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions
Experimental: Arm III (WP, SSP)
Patients receive intervention as in Arm I. Patients also undergo collection of blood and urine samples on study.
Other: Questionnaire Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo collection of blood and urine samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Other: Dietary Intervention
Consume SSPs
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions
Other: Dietary Intervention
Consume WPs
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in chronic inflammatory biomarkers
Time Frame: Up 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.
Up to 42 days
Differences in percentages of immune cell populations
Time Frame: Up 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.
Up to 42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

Ohio Soybean Council

Investigators

  • Principal Investigator: Holli Loomans-Kropp, PhD, MPH, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 10, 2026

First Submitted That Met QC Criteria

June 10, 2026

First Posted (Actual)

June 16, 2026

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-25053 (Other Identifier: Ohio State University Comprehensive Cancer Center)
  • NCI-2026-01822 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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