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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05055362
Enrollment
15
Registered
2021-09-24
Start date
2021-09-22
Completion date
2022-03-04
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Overweight and Obesity

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%).

Interventions

OTHERHoney Spice Group

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

Sponsors

National Kidney Foundation, United States
CollaboratorOTHER
University of Florida
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
inflammation markers10 daysDifference in salivary inflammation marker, CRP, concentration pre and post.

Secondary

MeasureTime frameDescription
Dietary and Spice habits10 daysRelationship between dietary and spice habits and inflammation markers

Other

MeasureTime frameDescription
Albuminuria10 daysDetermining relationship between inflammation markers and albuminuria

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026