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
• Status: Completed
• Phase: N/A
• Start date: September 22, 2021
• Est. completion date: March 4, 2022

Study information

• Verified date: June 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Inflammation
• Kidney Diseases
• Overweight
• Overweight and Obesity
• Renal Insufficiency, Chronic

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