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

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT05055362
• Collaborator: National Kidney Foundation (Other)
• Enrollment: 15
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.4
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases; Overweight and Obesity	Other: Honey Spice Group	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study
• Actual Study Start Date: Sep 22, 2021
• Actual Primary Completion Date: Feb 17, 2022
• Actual Study Completion Date: Mar 4, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. inflammation markers [10 days]

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

2. inflammation markers [10 days]

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

Secondary Outcome Measures

1. Dietary and Spice habits [10 days]

   Relationship between dietary and spice habits and inflammation markers

Other Outcome Measures

1. Albuminuria [10 days]

   Determining relationship between inflammation markers and albuminuria

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32606

Sponsors and Collaborators

• University of Florida
• National Kidney Foundation

Investigators

• Principal Investigator: Jeanette Andrade, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeanette Andrade, Assistant Professor, University of Florida
• ClinicalTrials.gov Identifier: NCT05055362
• Other Study ID Numbers: IRB202101532
• First Posted: Sep 24, 2021
• Last Update Posted: Apr 18, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Inflammation; Overweight

Study Results

No Results Posted as of Apr 18, 2022