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

Not Applicable

Completed

• Conditions: Overweight and Obesity; Chronic Kidney Diseases
• Interventions: Other: Honey Spice Group

• Registration Number: NCT05055362
• Lead Sponsor: University of Florida

Brief 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.

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 Timeline

• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-21
• Study Start: 2021-09-22
• Study First Posted: 2021-09-24
• Primary Completion: 2022-02-17
• Study Completion: 2022-03-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Honey Spice Group	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%).

Primary Outcome Measures

Name	Time	Method
inflammation markers	10 days	Difference in salivary inflammation marker, IL-6, concentration pre and post.

Secondary Outcome Measures

Name	Time	Method
Dietary and Spice habits	10 days	Relationship between dietary and spice habits and inflammation markers

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States