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临床试验/NCT05055362
NCT05055362已完成不适用

Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study

University of Florida2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年9月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
inflammation markers

研究概览

简要总结

The purpose of this research is to determine the effect a spiced-infused baked good has on inflammatory biomarkers in adults who are overweight and/or who has chronic kidney disease. Participants will be involved for 10 days in this research study.

详细描述

The dietary intervention will for 10-days, in which participants will eat a baked good each day for a total of 10 days. This baked good contains honey and spices (cinnamon and turmeric). At the first day of the study, participants will provide a urine sample, saliva sample, be weighed, take a pregnancy test, complete a total of 3 surveys - dietary and spice intake and demographics. Each survey will take no more than 10 minutes for a total of 30 minutes. At the end of the 10 days, participants will provide a saliva sample and complete 2 surveys - dietary and spice intake. Each survey will take no more than 10 minutes for a total of 20 minutes. Each day of the baked good intervention, participants will tick off the amount of baked good consumed (100%, 75%, 50%, 25%, 0%).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults who have been diagnosed with CKD and/or have a BMI >24.9
  • have no additional chronic diseases or GI disorders or GI disturbances
  • age 18 years or older
  • no food allergies or dietary restrictions
  • all with no contraindications to consuming anything by mouth as per their physician

排除标准

  • no diagnosis of CKD or BMI <24.9
  • GI disorders, diagnosed with other chronic diseases and conditions, gastrointestinal disturbances
  • pregnant and/or lactating
  • under 18 years old
  • food allergies to wheat, almonds, or aversion to turmeric, cinnamon, and honey. -Dietary restrictions as medically indicated
  • trouble chewing/swallowing as confirmed by physician

结局指标

主要结局

inflammation markers

时间窗: 10 days

Difference in salivary inflammation marker, CRP, concentration pre and post.

次要结局

  • Dietary and Spice habits(10 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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