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Impact of Peanut Consumption on Stress, Immune Function, Inflammation, and Cardiovascular Health in High-Stress Individuals

Effects of Peanut Consumption on Physiological and Psychosocial Stress, Circulating Immune Cell Status, Markers of Inflammation and Cardiovascular Disease Risk, and Gastrointestinal Health in High-Stress Individuals

The purpose of this research is to determine whether peanut consumption improves indicators of cardiovascular disease (CVD) risk in human subjects following the consumption of study foods.

研究概览

详细说明

The overall goal of the proposed study is to determine whether peanut consumption improves indices of cardiovascular disease (CVD) risk in human subjects with high levels of perceived chronic stress. Chronic stress is a growing public health concern and is associated with adverse health outcomes, including CVD. Stress, experienced when a person feels that environmental, physiological, or psychosocial demands tax or exceed their adaptive capacity, triggers a coordinated response from the sympathetic nervous system (SNS) and hypothalamic- pituitary- adrenal (HPA) axis increasing blood pressure, driving systemic inflammation, and affecting the immune system by accelerating the output of disease-promoting immune cells from bone marrow.

研究类型

介入性

注册 (估计的)

70

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。

学习联系方式

研究联系人备份

学习地点

    • California
      • Davis、California、美国、95616
        • 招聘中
        • Western Human Nutrition Research Center
        • 接触:
        • 接触:
        • 首席研究员:
          • Ryan Snodgrass, PhD
        • 副研究员:
          • Danielle Lemay, PhD
        • 副研究员:
          • Mary Kable, PhD
        • 副研究员:
          • Kevin Laugero, PhD

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
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Males and females
  • 18-65 years old
  • BMI ≥ 18.5 kg/m2 and ≤ 39.9 kg/ m2
  • Recruitment will be based on Perceived Stress Scale - 4 (PSS-4) score

Exclusion Criteria:

  • Less than 18 and over 65 years old
  • Pregnant or lactating women
  • Adults who rely on prescription medication that may influence study variables, apart from birth control
  • BMI < 18.5 kg/m2 and > 39.9 kg/m2
  • Smokers who currently use tobacco- or marijuana-containing products including e-cigarettes, vape pens, pod mods, tanks, and electronic nicotine delivery devices (ENDS)
  • Habitual consumption of nuts, nut butters, nut powders, nut side dishes, nut bars or other nut products
  • Known food allergies (milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, sesame, corn) due to samples not prepared in a hypoallergenic environment
  • Currently living in close contact with individuals who have an allergy to peanuts, in order to avoid exposing these individuals to an allergen
  • Self-reported history of difficulties with blood drawing procedures including prior fainting or dizziness, or veins assessed as not suitable for four separate venipunctures by licensed phlebotomist
  • Diagnosed active chronic diseases for which the individual is currently taking daily medication, including but not limited to:

    • Diabetes mellitus, cardiovascular disease, cancer, gastrointestinal disorders, kidney disease, liver disease, bleeding disorders, asthma, autoimmune disorders, hypertension, osteoporosis
  • Recent minor surgery (within 4 weeks) or major surgery (within 16 weeks)
  • Known gallbladder disease or history of cholecystectomy
  • History of gastrointestinal surgery, including gastric bypass surgery or resection
  • Diagnosis of irritable bowel syndrome
  • Recent antibiotic therapy (within 4 weeks)
  • Recent hospitalization (within 4 weeks)
  • Current participation in another research study
  • Has HIV/AIDS, hepatitis, or another disease that affects the immune system
  • Gives regular blood donations and is unwilling to stop during the study
  • Blood Pressure ≥ 140 mmHg systolic or 90 mmHg diastolic
  • Current diagnoses of an eating disorder (ex. anorexia, bulimia, etc.)
  • High - very high triglyceride levels: ≥ 300 mg/dL
  • Adults who are unable to consent, individuals who are not yet adults (infants, children and teenagers), pregnant women and prisoners will be excluded from participation in the study
  • Participants who are unwilling to collect and transport urine, stool and saliva samples
  • Abnormal hemoglobin and/or hematocrit levels
  • Abnormal liver function (defined as liver enzymes that are >200% of upper limit (ALT upper limit is 43 U/L or Aspartate transaminase (AST) upper limit is 54 U/L)
  • Unwillingness to discontinue probiotic, prebiotic, fiber, or other supplements (except RDA-level vitamin and mineral supplements) during the study
  • Unwilling to consume study foods
  • Alcohol consumption > 20 g/day

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:基础科学
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Peanut Intervention followed by corn chips Intervention
Participants will be asked to consume 42g of peanuts with skin daily for 4 weeks. Following a 4-week washout, the participant will then be asked to consume 45g of corn chips daily for 4 weeks.
42g roasted salted peanuts with skins consumed daily
Corn chips (45g)
实验性的:Corn chip Intervention followed by Peanut Intervention
The participant will be asked to consume 45g of corn chips daily for 4 weeks. Following a 4-week washout, the participant will be then asked to consume 42g of peanuts with skin daily for 4 weeks.
42g roasted salted peanuts with skins consumed daily
Corn chips (45g)

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
Change in psychosocial stress over time
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks

The PSS-10 will be administered 4 times during the study. The 10-item Perceived Stress Scale (PSS-10) is a validated, standard instrument used to assess subjective perceptions of chronic psychological stress (i.e., excessive demands, insufficient coping resources, and a perceived lack of control).

The minimum score is 0 and the maximum score is 40. Higher scores indicate greater severity of psychosocial stress.

Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of allostatic load following dietary interventions
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Before and after each intervention, cumulative physiological stress load, also referred to as allostatic load (AL), will be calculated. AL will be derived from 12-h overnight urinary cortisol, norepinephrine, and epinephrine levels (corrected for urinary creatinine levels), resting systolic and diastolic blood pressure, and overnight fasted waist-to-hip ratio, fasting serum levels of high-sensitivity C-reactive protein (hs-CRP), cholesterol, HDL-cholesterol, fasting plasma dehydroepiandrosterone sulfate (DHEA-S), and whole blood glycohemoglobin (HbA1c).
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of monocyte gene expression
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Total monocytes isolated from human peripheral blood mononuclear cells (PBMCs) at baseline and post-intervention will be collected, and their global gene expression will be analyzed by ribonucleic acid (RNA) sequencing.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of cytokine and interferon production in PBMCs
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Monocytes isolated from human peripheral blood mononuclear cells (PBMCs) will be challenged with and without toll-like receptor ligands to assess cytokine and interferon production in low- and high-stress subjects at baseline and after intervention.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of cytotoxicity of peripheral natural killer cells
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
The cytotoxicity of peripheral natural killer (NK) cells isolated from subject's peripheral blood mononuclear cells (PBMCs) of low- and high-stress individuals at baseline and after intervention will be assessed using an ex vivo cytotoxicity assay with human erythroleukemic cell line (K562) target cells.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of interferon-gamma
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Interferon-gamma (IFN-γ) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of tumor necrosis factors alpha and beta
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Tumor necrosis factors alpha and beta (TNF-α, TNF-β) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of interleukins
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
A panel of interleukins: (IL) (IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of fibroblast growth factor
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Fibroblast growth factor (FGF) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of granulocyte-macrophage colony-stimulating factor
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Granulocyte-macrophage colony-stimulating factor (GM-CSF) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery:
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of thymus and activation-regulated chemokine
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Thymus and activation-regulated chemokine (TARC). will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of macrophage inflammatory proteins-1 alpha and beta
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Macrophage inflammatory proteins-1 alpha and beta (MIP-1α, MIP-1β) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of macrophage-derived chemokine
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Macrophage-derived chemokine (MDC) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of monocyte chemoattractant proteins-1 and -4
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Monocyte chemoattractant proteins-1 and -4 (MCP-1, MCP-4) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of interferon gamma-induced protein-10
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Interferon gamma-induced protein-10 (IP-10) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of eotaxin and eotaxin-3
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Eotaxin and eotaxin-3 will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of C-reactive protein
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
C-reactive protein (CRP) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of intercellular adhesion molecule-1
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Intercellular adhesion molecule-1 (ICAM-1) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of placental growth factor
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Placental growth factor (PlGF) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of serum amyloid A
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Serum amyloid A (SAA) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of angiopoietin-1 receptor
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Angiopoietin-1 receptor (Tie-2) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of vascular cell adhesion molecule-1
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Vascular cell adhesion molecule-1 (VCAM-1) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of vascular endothelial growth factors A, C, and D
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Vascular endothelial growth factors A, C, and D (VEGF-A, VEGF-C, VEGF-D) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of vascular endothelial growth factor receptor-1
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Vascular endothelial growth factor receptor-1 (VEGFR-1/Flt-1) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of monocyte phenotype
大体时间:Baseline, 4 weeks, 8 weeks, 12 weeks
Classical monocytes, intermediate monocytes, and non-classical monocytes, will be identified by leukocyte common antigen (CD45+), Low-density lipoprotein receptor-related protein 1 (CD91+), cluster of differentiation 14 (CD14), cluster of differentiation 16 (CD16), and cluster of differentiation 3 (lin-CD3)/cluster of differentiation 66b (CD66b)/neural cell adhesion molecule (CD56)/cluster of differentiation 19 (CD19) using flow cytometry.
Baseline, 4 weeks, 8 weeks, 12 weeks
Change from baseline of monocyte functional profile
大体时间:Baseline, 4 weeks, 8 weeks, 12 weeks
Cellular activation of classical monocytes, intermediate monocytes, and non-classical monocytes will be assessed by expression of cluster of differentiation 11b (CD11b) and cluster of differentiation 163 (CD163).
Baseline, 4 weeks, 8 weeks, 12 weeks
Change from baseline of natural killer cell phenotype
大体时间:Baseline, 4 weeks, 8 weeks, 12 weeks
Natural killer (NK) cells will be identified by CD45+, cluster of differentiation 56+ (CD56+), and lin-CD3/CD66b/CD14/CD19 using flow cytometry.
Baseline, 4 weeks, 8 weeks, 12 weeks
Change from baseline of natural killer cell functional profile
大体时间:Baseline, 4 weeks, 8 weeks, 12 weeks
Natural killer (NK) cell maturation status and cytotoxic potential via CD16, cluster of differentiation 57 (CD57), killer cell lectin-like receptor K1 (NKG2D), and cluster of differentiation 159 (NKG2A) will be analyzed using flow cytometry.
Baseline, 4 weeks, 8 weeks, 12 weeks

次要结果测量

结果测量
措施说明
大体时间
Changes in stool consistency
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Participants will provide stool samples at 4 times throughout the study. Stool samples will be used to confirm the stool consistency reported by the study subject.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in stool metrics
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Participants will provide stool samples at 4 times throughout the study. Stool samples will be used to determine the whole stool weight.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in bowel movement frequency
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
During the week prior to each intervention and the final week of each intervention, participants will maintain a stool diary for recording frequency of bowel movements.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in Gastrointestinal (GI) symptoms
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
During the week prior to each intervention and the final week of each intervention, a short GI Symptoms Questionnaire will be administered via Qualtrics to record occurrence of gastric symptoms.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in gut microbial diversity
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Participants will provide stool samples at 4 times throughout the study. Stool samples will be used to determine the microbial community composition by 16-subunit ribosomal ribonucleic acid (16S rRNA) amplicon sequence analysis.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in stool short chain fatty acids
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Participants will provide stool samples at 4 times throughout the study. Stool samples will be used to measure the amount of fecal short chain fatty acids (SCFAs).
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in gut inflammatory markers
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Participants will provide stool samples at 4 times throughout the study. Stool samples will be used to measure the inflammatory marker, fecal calprotectin.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in salivary cortisol
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks

To assess waking and diurnal cortisol fluctuations, saliva will be collected at home at selected times upon waking and before bedtime. The waking saliva sample must be collected within 10-15 minutes of waking. Following the waking sample, participants will be asked to collect additional saliva samples at 15, 30, 45, and 60 minutes after the waking sample, as well as a saliva sample before bedtime.

In total, participants will return 24 saliva samples (6 per visit) throughout the study.

Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary cortisol levels
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Before and after each intervention, 12-hour overnight urinary cortisol will be measured.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary epinephrine levels
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Before and after each intervention, 12-hour overnight urinary epinephrine levels will be measured.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary norepinephrine levels
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Before and after each intervention, 12-hour overnight urinary norepinephrine levels will be measured.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary creatinine levels
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Before and after each intervention, 12-hour overnight urinary creatinine levels will be measured.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in resting blood pressure
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Research team will collect resting blood pressure (systolic and diastolic) in mmHg (millimeters of mercury).
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in dietary intake
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Dietary intake will be assessed by using the Automated Self-Administered 24-hour (ASA24®) dietary assessment tool, a web-based tool that enables multiple, automatically coded, self-administered 24-hour recalls. Three dietary recalls will be conducted in the week preceding and the final week of each intervention period, for a total of 12, 24-hour dietary recalls.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in Body Weight
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Research team will collect weight in kg.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in white blood cell count
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
White blood cell (WBC) count will be measured by a DxH 520 Hematology analyzer.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in lymphocyte count
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Lymphocyte (LY) count will be measured by a DxH 520 Hematology analyzer.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in monocyte count
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Monocyte (MO) count will be measured by a DxH 520 Hematology analyzer.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in neutrophil granulocyte count
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Neutrophil granulocyte (NE) count will be measured by a DxH 520 Hematology analyzer.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in eosinophil count
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Eosinophil (EO) count will be measured by a DxH 520 Hematology analyzer.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in basophil count
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Basophil (BA) count will be measured by a DxH 520 Hematology analyzer.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of triglycerides
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Lipid-related markers including triglycerides will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of total cholesterol
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Lipid-related markers including total cholesterol will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of HDL-cholesterol
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Lipid-related markers including HDL-cholesterol (HDL-C) will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of LDL-cholesterol
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Lipid-related markers including LDL-cholesterol (LDL-C) will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of glucose
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
Plasma glucose will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in gut transit time
大体时间:Baseline, 4 weeks, 8 weeks, and 12 weeks
During the week prior to each intervention and the final week of each intervention, participants will consume a muffin containing blue food dye. Participants will log the date and time of consumption, and will log each bowel movement until stool color changes. This will be used to measure gut transit time.
Baseline, 4 weeks, 8 weeks, and 12 weeks

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:Ryan Snodgrass, PhD、United States Department of Agriculture - Western Human Nutrition Research Center

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 (估计的)

2026年9月1日

初级完成 (估计的)

2028年8月1日

研究完成 (估计的)

2028年8月1日

研究注册日期

首次提交

2025年8月4日

首先提交符合 QC 标准的

2026年7月24日

首次发布 (实际的)

2026年7月29日

研究记录更新

最后更新发布 (实际的)

2026年9月11日

上次提交的符合 QC 标准的更新

2026年9月8日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

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

是的

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.

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