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

NCT05055362 | Completed

• 1 other identifier: IRB202101532
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Dietary and Spice habits

  10 days

Other Outcomes (1)

• Albuminuria

  10 days

Study Arms (1)

Honey Spice Group

EXPERIMENTAL

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

Interventions

Honey Spice Group OTHER

Consume baked good daily for 10 days and provide samples of saliva, urine and dietary habits and spice intake.

Honey Spice Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Kidney Foundation, United States: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32606, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Overweight; Obesity

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Jeanette Andrade

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 24, 2021
• Study Start: September 22, 2021
• Primary Completion: February 17, 2022
• Study Completion: March 4, 2022
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)