Change in Plasma Urolithins and Vitamin ENCT06140602
Postprandial Urolithin Patterns Following Pecan Consumption
A study testing Intervention shake in people with Change in Plasma Urolithins and Vitamin E, run by University of Georgia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Change in Plasma Urolithins and Vitamin E
- What is being tested?
- Intervention shake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Human Nutrition Lab
Athens, Georgia, 30601
Christine Ward, M.S, 706-542-7142, christine.ward@uga.edu
Chad M Paton, PhD
About this study
Official title: Postprandial Urolithin Response to a Pecan-Enriched Meal
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.
Read the 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, the investigators 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.
- Being tested
- Intervention shake
- Keywords
- Urolithins, Pecans, Dietary biomarker, Tocopherols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention shakeOther
Also called Pecan shake
The pecan shake contains 69g of pecans
| Study group | Role | What they receive |
|---|---|---|
| Intervention shake | Experimental | The pecan shake is comprised of 1% milk, chocolate powder (Nesquik), soy lecithin, whole blended pecans, and water. Receives: Other: Intervention shake |
| Control shake | No intervention | the control cream shake is comprised of 1% milk, chocolate powder (Nesquik), soy lecithin, dextrin, heavy whipping cream, and water. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urolithins pattern in blood plasma
A fasting/baseline blood draw, followed to 2 hours, 4 hours, 6 hours, 8 hours, 12 hours 24h, 48h.
Measured: baseline blood draw 8 hours postprandial, then at 12 hours, 24 hours and 48 hours postprandial time points
Secondary outcomes (1)
Which isoform of Uros (A, B, C and it's glucuronides (Uro A-G, Uro B-G) will peak
Which isoform will be seeing in greater amount when tracked
Measured: baseline blood draw 8 hours postprandial, then at 12 hours, 24 hours and 48 hours postprandial time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start18 Jul 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Change in Plasma Urolithins and Vitamin EStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, crossover, single-blinded study with one intervention (breakfast milkshake
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Commodity Commission for Pecans, American Pecan Counsel
- Responsible party
- Principal investigator, Chad Paton, University of Georgia
- Investigators
- Chad M Paton, PhD, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140602
- Sponsor's protocol ID
- PROJECT00007260
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Urolithin Response to a Pecan-Enriched Meal
- ClinicalTrials.gov ID
- NCT06140602
- Acronym / sponsor ID
- PROJECT00007260
- Keywords
- Urolithins, Pecans, Dietary biomarker, Tocopherols
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- Georgia Commodity Commission for Pecans, American Pecan Counsel
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 20 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, the investigators 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, crossover, single-blinded study with one intervention (breakfast milkshake
| Arm | Type | Receives |
|---|---|---|
| Intervention shake | Experimental | Other: Intervention shakeThe pecan shake is comprised of 1% milk, chocolate powder (Nesquik), soy lecithin, whole blended pecans, and water. |
| Control shake | No intervention | –the control cream shake is comprised of 1% milk, chocolate powder (Nesquik), soy lecithin, dextrin, heavy whipping cream, and water. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention shakeAlso: Pecan shakeThe pecan shake contains 69g of pecans | Other | Intervention shake |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad M Paton, PhD principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention shake in people with Change in Plasma Urolithins and Vitamin E, run by University of Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chad M Paton, PhD (7065423750, Cpaton@uga.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.