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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Overweight and Obesity
• Intervention / Treatment: Other: Honey Spice Group

Detailed 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%).

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32606
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Honey Spice Group; The dietary intervention will be a 10-day feasibility trial, using a honey, spice infused baked good. The participants will receive the baked good on day 1 and will be asked to consume a 50-gram baked good daily for 10 days with or without their meals. The honey, spice infused baked good will contain 15g honey and 3g of spice blend (turmeric and cinnamon). A saliva sample will be taken at the start of the intervention (day 1) before consumption of the baked good and after the intervention ends (day 10), 2 hours after consuming the final baked good. Additionally, participants will provide a urine sample to determine microalbuminuria level, complete a spice-consumption survey and a semi-quantitative food frequency questionnaire (day 1). At day 10, participants will indicate if their spice consumption and dietary intake has changed over the past 10 days. Each day, they will tick off the amount of baked good consumed (100%, 75%, 50%, 25%, 0%).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inflammation markers	Difference in salivary inflammation marker, CRP, concentration pre and post.	10 days
inflammation markers	Difference in salivary inflammation marker, IL-6, concentration pre and post.	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary and Spice habits	Relationship between dietary and spice habits and inflammation markers	10 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Albuminuria	Determining relationship between inflammation markers and albuminuria	10 days

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Kidney Foundation
• Investigators: Principal Investigator: Jeanette Andrade, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2021
• Primary Completion (Actual): February 17, 2022
• Study Completion (Actual): March 4, 2022

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 7, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Overnutrition; Nutrition Disorders; Body Weight; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Inflammation; Overweight
• Other Study ID Numbers: IRB202101532

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Will only be able to provide group information such as demographics

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No