A Dietary Intervention (Soy Soft Pretzels) for Reducing Chronic Inflammation in Obese Individuals
2026年6月10日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Ohio
-
Columbus、Ohio、美国、43210
- Ohio State University Comprehensive Cancer Center
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
辅助研究
采集血液和尿液样本
其他名称：
Consume SSPs
其他名称：
Consume WPs
其他名称：
|
|
实验性的：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.
|
辅助研究
采集血液和尿液样本
其他名称：
Consume SSPs
其他名称：
Consume WPs
其他名称：
|
|
实验性的：Arm III (WP, SSP)
Patients receive intervention as in Arm I. Patients also undergo collection of blood and urine samples on study.
|
辅助研究
采集血液和尿液样本
其他名称：
Consume SSPs
其他名称：
Consume WPs
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Differences in chronic inflammatory biomarkers
大体时间：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
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Holli Loomans-Kropp, PhD, MPH、Ohio State University Comprehensive Cancer Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年6月1日
初级完成 (估计的)
2026年9月30日
研究完成 (估计的)
2026年12月31日
研究注册日期
首次提交
2026年6月10日
首先提交符合 QC 标准的
2026年6月10日
首次发布 (实际的)
2026年6月16日
研究记录更新
最后更新发布 (实际的)
2026年6月16日
上次提交的符合 QC 标准的更新
2026年6月10日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- OSU-25053 (其他标识符：Ohio State University Comprehensive Cancer Center)
- NCI-2026-01822 (注册表标识符：CTRP (Clinical Trial Reporting Program))
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.