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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT07650409
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 49 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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 Dates

Start date
Jun 1, 2025
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • 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.
  • 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.
  • Experimental: Arm III (WP, SSP)
    Patients receive intervention as in Arm I. Patients also undergo collection of blood and urine samples on study.

Primary Outcome Measure

Differences in chronic inflammatory biomarkers [ Time Frame: Up to 42 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

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