- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06140602
Postprandial Urolithin Patterns Following Pecan Consumption
Postprandial Urolithin Response to a Pecan-Enriched Meal
Study Overview
Status
Intervention / Treatment
Detailed Description
This study aims to find a new marker for the consumptions of pecans, and any other food containing ellagitannins. Our goal is to find out the patterns of Urolithins (Uros), a metabolite originated from ellagic acid by the gut microbiota. Previous study supports that Urolithins and it's glucuronides conjugates, especially Uro A glucuronide, increase in blood plasma after 4-week intervention of chronic consumption of pecans. However, little is known about Uros in plasma after an acute meal containing ellagitannins. For this reason, this project's goal is to be able to hourly track Uros after a pecan enriched meal.This trial will be a double-blinded, randomized, cross-over design in humans. There will be three study visits. The screening visit (v1) will entail signing informed consent documents, anthropometric measurements, and receiving their dinner entrée for the night before v2. The two testing visits (v2 and v3) include blood draws after consuming one of the two different test meals: 1) a breakfast shake consisting primarily of pecans, Nesquik and 1% milk, or 2) a breakfast shake consisting primarily of heavy whipping cream, Nesquik and 1% milk. There will be a 6-14 day washout period between each study visit. There will be a total of thirty participants in this study (n=30). All visits will take place in the Human Nutrition Lab (HNL) at the University of Georgia in Athens.
Only Dr. Chad Paton and/or members of his research team will screen potential participants interested in the study. The screening process will be done over the phone, or in person. In contrast, the consent process will be done in person only. If potential participants complete an online interest screening form they will be contacted by the researchers listed above. These researchers will conduct the full telephone screening and inform the potential participant whether or not they qualify for the study. For participants that have completed the online interest form, researchers will clarify questions that have previously been asked, and focus on collecting new information in order to compete the full screening. If the potential participant does qualify for the study, an in-person Screening and Consent Visit (v1) will be scheduled during or after this phone call.
During the in-person Screening and Consent Visit, the participant will be provided with detailed verbal and written information regarding the study and activities it entails. This includes information regarding the nutritional content of the breakfast shakes, pre-visit 24-hour diet protocol (verbal and paper-copy instructions), and blood drawing procedures. If the participant willingly consents to the study and signs the consent form, we will proceed with the rest of the screening visit. If participants are eligible to participate in the study after the Screening Visit, then they will complete two additional testing visits. After the fasting blood draw, participants will be given a breakfast shake to consume. Liquid chromatography tandem mass spectrometry (LC-MS/MS) will be used to quantify plasma urolithin-A, -B, and -C as well as their glucuronide conjugates. Additionally, LC-MS/MS will be used to measure plasma tocopherols and tocotrienols. Plasma changes in triglycerides and glucose will be determined by enzyme assay.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chad M Paton, PhD
- Phone Number: 7065423750
- Email: Cpaton@uga.edu
Study Contact Backup
- Name: Gabriela Brocca, B.s
- Phone Number: 7063635607
- Email: gabriela.almeidabrocca@uga.edu
Study Locations
-
-
Georgia
-
Athens, Georgia, United States, 30601
- Recruiting
- Human Nutrition Lab
-
Contact:
- Christine Ward, M.S
- Phone Number: 706-542-7142
- Email: christine.ward@uga.edu
-
Principal Investigator:
- Chad M Paton, PhD
-
Sub-Investigator:
- Gabriela Brocca, B.S
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy individuals with BMI between 18.5 - 29.9 kg/m2. Birth control is accepted, and any medications that do not influence with metabolism.
Exclusion Criteria:
- Individuals outside of this BMI range, individuals with chronic diseases of the gastrointestinal system, individuals currently taking antibiotics, or that have a fever, or have any infection. Individuals can not be taking prebiotics/probiotics supplementation, as well as multivitamin.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention shake
The pecan shake is comprised of 1% milk, chocolate powder (Nesquik), soy lecithin, whole blended pecans, and water.
|
The pecan shake contains 69g of pecans
Other Names:
|
No Intervention: Control shake
the control cream shake is comprised of 1% milk, chocolate powder (Nesquik), soy lecithin, dextrin, heavy whipping cream, and water.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urolithins pattern in blood plasma
Time Frame: baseline blood draw 8 hours postprandial, then at 12 hours, 24 hours and 48 hours postprandial time points
|
A fasting/baseline blood draw, followed to 2 hours, 4 hours, 6 hours, 8 hours, 12 hours 24h, 48h.
|
baseline blood draw 8 hours postprandial, then at 12 hours, 24 hours and 48 hours postprandial time points
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Which isoform of Uros (A, B, C and it's glucuronides (Uro A-G, Uro B-G) will peak
Time Frame: baseline blood draw 8 hours postprandial, then at 12 hours, 24 hours and 48 hours postprandial time points
|
Which isoform will be seeing in greater amount when tracked
|
baseline blood draw 8 hours postprandial, then at 12 hours, 24 hours and 48 hours postprandial time points
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chad M Paton, PhD, University of Georgia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PROJECT00007260
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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