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OpenTrials
Completed

NCT Number: NCT05055362

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

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.

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Key information

About this study

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%).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Honey Spice Group

Other

Consume baked good daily for 10 days and provide samples of saliva, urine and dietary habits and spice intake.

Primary outcomes

  1. inflammation markers

    Time frame: 10 days

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

  2. inflammation markers

    Time frame: 10 days

    Difference in salivary inflammation marker, IL-6, concentration pre and post.

Secondary outcomes

  1. Dietary and Spice habits

    Time frame: 10 days

    Relationship between dietary and spice habits and inflammation markers

Other outcomes

  1. Albuminuria

    Time frame: 10 days

    Determining relationship between inflammation markers and albuminuria

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Kidney Foundation, United States

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 24, 2021
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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