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NCT05055362 Clinical Trial

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

Overweight and Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05055362
Other study ID # IRB202101532
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 22, 2021
Est. completion date March 4, 2022

Study information
Verified date April 2022
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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%).

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date March 4, 2022
Est. primary completion date February 17, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Honey Spice Group
Consume baked good daily for 10 days and provide samples of saliva, urine and dietary habits and spice intake.

Locations
Country Name City State
United States University of Florida Gainesville Florida

Sponsors (2)
Lead Sponsor Collaborator
University of Florida National Kidney Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Albuminuria Determining relationship between inflammation markers and albuminuria 10 days
Primary inflammation markers Difference in salivary inflammation marker, CRP, concentration pre and post. 10 days
Primary inflammation markers Difference in salivary inflammation marker, IL-6, concentration pre and post. 10 days
Secondary Dietary and Spice habits Relationship between dietary and spice habits and inflammation markers 10 days
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