Recruiting

Urolithin Patterns

Sponsor:

University of Georgia

Code:

NCT06140602

Conditions

Change in Plasma Urolithins and Vitamin E

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

Interventions

Intervention shake

Study Details

Brief summary:

Pecan-enriched diets have been linked to improved cardiovascular health, including postprandial blood lipids and microvascular reactivity in older adults. This has led to recommendations to increase regular pecan consumption, however there is no consistent plasma measure of pecan intake. Traditionally, plasma tocopherols have been used, although they reach peak concentrations in plasma around 6-8 hours post pecan consumption, leading to high variability at 24 hours. Therefore, a more reliable biomarker of pecan consumption needs to be defined. The purpose of this study is to analyze the postprandial response of urolithins in human plasma after a pecan enriched meal and compare their appearance pattern to tocopherols. This single blind, randomized crossover trial is designed to provide two acute meal challenges for each participant (anticipated n=30, BMI 18.5 - 24.9, age 18-30y) with a washout period of \~14 days between each challenge. The intervention meal contains 68g of pecans and the control shake contains whipped cream instead of pecans, and the order of each meal will be randomly assigned. Blood draws will be collected at fasting (0-h) and every 2 hours until 8 hours postprandial, then at 12-, 24-, and 48h after the meal. The levels of urolithins and tocopherols will be quantified through liquid chromatography tandem mass spectrometry. To our knowledge, this is the first time urolithins will be tracked in plasma up to 48h post meal. This study will be used to establish of a new and more consistent dietary biomarker for pecans.

Conditions

Change in Plasma Urolithins and Vitamin E

Study ID

NCT06140602

Start date

Jul 18, 2023

Status verified date

Nov, 2023

Completion date

Jul 30, 2024

Anticipated

Primary completion date

May 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy individuals with BMI between 18.5 - 29.9 kg/m2
  • Does not make use of medication (Birth control, and antidepressants SSRIs accepted)
  • Does not make use of any nicotine products
  • Has not been diagnosed with any diseases that can impair swallowing, digestion or lipid metabolism

Exclusion Criteria:

  • Individuals with BMI < 18.5 or BMI > 29.9 kg/m2
  • Individuals with chronic diseases of the gastrointestinal system
  • Individuals currently taking antibiotics or any other medications not included on the inclusion criteria
  • Individuals that have a current fever, or have any infection
  • Individuals can not be taking prebiotics/probiotics supplementation, as well as multivitamin.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention shake

The pecan shake is comprised of 1% milk, chocolate powder (Nesquik), soy lecithin, whole blended pecans, and water.

no intervention: Control shake

the control cream shake is comprised of 1% milk, chocolate powder (Nesquik), soy lecithin, dextrin, heavy whipping cream, and water.

Interventions

Intervention shake

The pecan shake contains 69g of pecans

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Human Nutrition Lab

Recruiting

Athens, Georgia, United States, 30601

Contacts

Principal Investigator:

Chad M Paton, PhD

More Information

Sponsor

University of Georgia

Last update posted

Nov 24, 2023

Last verified

Nov, 2023

Keywords

  • Urolithins
  • Pecans
  • Dietary biomarker
  • Tocopherols

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Georgia on 2023-11-24.