Examining the Efficacy of a Soft Soy Pretzel Intervention in Altering Chronic Inflammation and Immune Profiles in Obese Individuals
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Differences in chronic inflammatory biomarkers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Biospecimen Collection (Procedure)
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.
干预措施: Dietary Intervention (Other)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Biospecimen Collection (Procedure)
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.
干预措施: Dietary Intervention (Other)
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.
干预措施: Questionnaire Administration (Other)
Arm III (WP, SSP)
Patients receive intervention as in Arm I. Patients also undergo collection of blood and urine samples on study.
干预措施: Biospecimen Collection (Procedure)
Arm III (WP, SSP)
Patients receive intervention as in Arm I. Patients also undergo collection of blood and urine samples on study.
干预措施: Dietary Intervention (Other)
Arm III (WP, SSP)
Patients receive intervention as in Arm I. Patients also undergo collection of blood and urine samples on study.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Differences in chronic inflammatory biomarkers
时间窗: 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.
Differences in percentages of immune cell populations
时间窗: 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.
次要结局
未报告次要终点
研究者
Holli Loomans-Kropp
Principal Investigator
Ohio State University Comprehensive Cancer Center