Postprandial InflammationNCT05017428
Absorption and Digestion Kinetics of Human Metabolites
A study testing Spermidine, Nicotinamide and PEA in people with Postprandial Inflammation, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate the effects oral supplementation with four human metabolites (spermidine, nicotinamide, palmitoylethanolamide (PEA), and oleoylethanolamide(OEA)) at varying doses on the circulating blood levels of these metabolites as well as their immediate effects on plasma… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Postprandial Inflammation
- What is being tested?
- Spermidine, Nicotinamide and PEA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2021to 1 Jul 2021
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 20-40 years old to constitute a young study population
- BMI: 19-27 kg/m2 to constitute a normal/healthy weight population
- Weight: 133lbs or more
- Subjects must be willing and able to consume a standardized breakfast bar containing cashews and dates (Larabar).
- Subjects must be willing to consume oral dietary supplement versions of spermidine, 1-methlynicotinamide, palmitoylethanolamide, and oleoylethanolamide.
- Subjects must be willing and able to undergo blood draws at the UC Davis Ragle Nutrition Center at 0, 1, 2, and 4 hours after supplementation with spermidine, niacinamide, palmitoylethanolamide, and oleoylethanolamide.
Who cannot join
- Smoker
- Anemia
- Documented chronic diseases including diabetes, thyroid disease, metabolic syndrome, cancer, autoimmune diseases, or previous cardiovascular events
- Any inflammatory bowel disease including IBS, Crohn's Disease, Celiac Disease
- Any allergy or sensitivity to wheat, gluten, or soy products
- Consumption of >1 alcoholic drink/day
Show all 15Show fewer
- Current consumption of any probiotic, prebiotic, or dietary supplements
- Extreme dietary or exercise patterns
- Recent weight fluctuations (greater than 10% in the last six months)
- Regular use of over-the-counter allergy or pain medications (>1/week)
- Taking prescription lipid medications (e.g. statins) or other supplements known to alter lipoprotein metabolism such as isoflavones.
- Use of any form of hormonal birth control including oral contraception pills, hormonal IUDs or rings, or hormonal birth control patches
- Illness such as flu or cold of any kind within the last two weeks
- Allergy to components of standardized breakfast bar (cashew/dates)
- Changes to any of the above during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis
Davis, California, 95616
About this study
The purpose of this pilot study is to evaluate the effects oral supplementation with four human metabolites (spermidine, nicotinamide, palmitoylethanolamide (PEA), and oleoylethanolamide(OEA)) at varying doses on the circulating blood levels of these metabolites as well as their immediate effects on plasma functionality and postprandial inflammation. 5 young healthy subjects will participate in a four armed study consisting of a Placebo arm and a Low, Medium, and High Dose arm. Subjects will be given a standardized breakfast along with supplementation with either an escalating dose (Low: 1x, Medium: 2x, High: 3x) of a combination of spermidine, nicotinamide, PEA and OEA or a placebo control and a time course of their blood plasma will be collected after supplementation. Plasma samples will be assessed for their concentration of spermidine, nicotinamide, PEA, and OEA as well as their experimental and clinical functionalities including their anti-inflammatory, antioxidant, and cholesterol efflux abilities on primary human macrophage.
- Conditions
- Postprandial Inflammation
- Being tested
- Spermidine, Nicotinamide, PEA, OEA, Wheat Flour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpermidineDietary supplement
Also called Primeadine
Spermidine in the form of a 0.1% spermidine wheat germ extract
NicotinamideDietary supplement
Also called Jarrow Niacinamide
Nicotinamide given as niacinamide
PEADietary supplement
Also called Nootropics Depot PEA
Palmitoylethanolamide given at 98% purity
OEADietary supplement
Also called Riduzone
Oleoylehtanolamide given at 90% purity
Wheat FlourDietary supplement
Wheat flour given as a placebo control
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | The Low Dose arm provides subjects with supplementation with 5mg of spermidine (in the form of 5g of a 0.1% spermidine wheat germ extract), 500mg of nicotinamide, 400mg of palmitoylethanolamide, and 200mg of oleoylethanolamide. Receives: Dietary Supplement: Spermidine; Dietary Supplement: Nicotinamide; Dietary Supplement: PEA; Dietary Supplement: OEA |
| Medium Dose | Experimental | The Medium Dose arm provides subjects with supplementation with 10mg of spermidine (in the form of 10g of a 0.1% spermidine wheat germ extract), 750mg of nicotinamide, 800mg of palmitoylethanolamide, and 400mg of oleoylethanolamide. Receives: Dietary Supplement: Spermidine; Dietary Supplement: Nicotinamide; Dietary Supplement: PEA; Dietary Supplement: OEA |
| High Dose | Experimental | The Low Dose arm provides subjects with supplementation with 15mg of spermidine (in the form of 15g of a 0.1% spermidine wheat germ extract), 1000mg of nicotinamide, 1200mg of palmitoylethanolamide, and 600mg of oleoylethanolamide. Receives: Dietary Supplement: Spermidine; Dietary Supplement: Nicotinamide; Dietary Supplement: PEA; Dietary Supplement: OEA |
| Placebo | Placebo comparator | In this arm the participants are given supplementation with a placebo control consisting of 15g of wheat flour. Receives: Dietary Supplement: Wheat Flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating Plasma Levels of Metabolites
Quantitative plasma concentrations of spermidine, nicotinamide, pamitoylethanolamide, and oleoylethanolamide (in nmol/L).
Measured: 1, 2, and 4 hours after ingestion
Secondary outcomes (1)
Anti-inflammatory capacity of plasma
Ex vivo assessment of the effects of subject plasma on the secretion of pro-inflammatory cytokine TNF-alpha (pg/mL) by primary human macrophage
Measured: 1, 2, and 4 hours after ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start8 Apr 2021
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postprandial InflammationStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Participants will take a supplement containing 4 metabolites at escalating doses compared with placebo after a standardized meal and their blood will be drawn at mutliple points throughout a postprandial time course to evaluate markers of inflammation, circulating levels of each metabolite, and plasma functionalities.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Zivkovic, PhD, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017428
- Sponsor's protocol ID
- 1725738
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rhodes CH, Hong BV, Tang X, Weng CY, Kang JW, Agus JK, Lebrilla CB, Zivkovic AM. Absorption, anti-inflammatory, antioxidant, and cardioprotective impacts of a novel fasting mimetic containing spermidine, nicotinamide, palmitoylethanolamide, and oleoylethanolamide: A pilot dose-escalation study in healthy young adult men. Nutr Res. 2024 Dec;132:125-135. doi: 10.1016/j.nutres.2024.10.006. Epub 2024 Oct 23.
PubMed 39549554
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption and Digestion Kinetics of Human Metabolites
- ClinicalTrials.gov ID
- NCT05017428
- Acronym / sponsor ID
- 1725738
- Conditions
- Postprandial Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 23 Aug 2021 (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.
The purpose of this pilot study is to evaluate the effects oral supplementation with four human metabolites (spermidine, nicotinamide, palmitoylethanolamide (PEA), and oleoylethanolamide(OEA)) at varying doses on the circulating blood levels of these metabolites as well as their immediate effects on plasma functionality and postprandial inflammation. 5 young healthy subjects will participate in a four armed study consisting of a Placebo arm and a Low, Medium, and High Dose arm. Subjects will be given a standardized breakfast along with supplementation with either an escalating dose (Low: 1x, Medium: 2x, High: 3x) of a combination of spermidine, nicotinamide, PEA and OEA or a placebo control and a time course of their blood plasma will be collected after supplementation. Plasma samples will be assessed for their concentration of spermidine, nicotinamide, PEA, and OEA as well as their experimental and clinical functionalities including their anti-inflammatory, antioxidant, and cholesterol efflux abilities on primary human macrophage.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will take a supplement containing 4 metabolites at escalating doses compared with placebo after a standardized meal and their blood will be drawn at mutliple points throughout a postprandial time course to evaluate markers of inflammation, circulating levels of each metabolite, and plasma functionalities.
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Dietary Supplement: Spermidine, Dietary Supplement: Nicotinamide, Dietary Supplement: PEA, Dietary Supplement: OEAThe Low Dose arm provides subjects with supplementation with 5mg of spermidine (in the form of 5g of a 0.1% spermidine wheat germ extract), 500mg of nicotinamide, 400mg of palmitoylethanolamide, and 200mg of oleoylethanolamide. |
| Medium Dose | Experimental | Dietary Supplement: Spermidine, Dietary Supplement: Nicotinamide, Dietary Supplement: PEA, Dietary Supplement: OEAThe Medium Dose arm provides subjects with supplementation with 10mg of spermidine (in the form of 10g of a 0.1% spermidine wheat germ extract), 750mg of nicotinamide, 800mg of palmitoylethanolamide, and 400mg of oleoylethanolamide. |
| High Dose | Experimental | Dietary Supplement: Spermidine, Dietary Supplement: Nicotinamide, Dietary Supplement: PEA, Dietary Supplement: OEAThe Low Dose arm provides subjects with supplementation with 15mg of spermidine (in the form of 15g of a 0.1% spermidine wheat germ extract), 1000mg of nicotinamide, 1200mg of palmitoylethanolamide, and 600mg of oleoylethanolamide. |
| Placebo | Placebo comparator | Dietary Supplement: Wheat FlourIn this arm the participants are given supplementation with a placebo control consisting of 15g of wheat flour. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 20-40 years old to constitute a young study population
- BMI: 19-27 kg/m2 to constitute a normal/healthy weight population
- Weight: 133lbs or more
- Subjects must be willing and able to consume a standardized breakfast bar containing cashews and dates (Larabar).
- Subjects must be willing to consume oral dietary supplement versions of spermidine, 1-methlynicotinamide, palmitoylethanolamide, and oleoylethanolamide.
Key exclusion criteria (15 listed)
- Smoker
- Anemia
- Documented chronic diseases including diabetes, thyroid disease, metabolic syndrome, cancer, autoimmune diseases, or previous cardiovascular events
- Any inflammatory bowel disease including IBS, Crohn's Disease, Celiac Disease
- Any allergy or sensitivity to wheat, gluten, or soy products
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 |
|---|---|---|
| SpermidineAlso: PrimeadineSpermidine in the form of a 0.1% spermidine wheat germ extract | Dietary supplement | High Dose, Low Dose, Medium Dose |
| NicotinamideAlso: Jarrow NiacinamideNicotinamide given as niacinamide | Dietary supplement | High Dose, Low Dose, Medium Dose |
| PEAAlso: Nootropics Depot PEAPalmitoylethanolamide given at 98% purity | Dietary supplement | High Dose, Low Dose, Medium Dose |
| OEAAlso: RiduzoneOleoylehtanolamide given at 90% purity | Dietary supplement | High Dose, Low Dose, Medium Dose |
| Wheat FlourWheat flour given as a placebo control | Dietary supplement | Placebo |
Primary outcome
Circulating Plasma Levels of Metabolites
Time frame: 1, 2, and 4 hours after ingestion
Quantitative plasma concentrations of spermidine, nicotinamide, pamitoylethanolamide, and oleoylethanolamide (in nmol/L).
1 secondary outcome
Anti-inflammatory capacity of plasma
Time frame: 1, 2, and 4 hours after ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Derived from this study: PubMed 39549554Rhodes CH, Hong BV, Tang X, Weng CY, Kang JW, Agus JK, Lebrilla CB, Zivkovic AM. Absorption, anti-inflammatory, antioxidant, and cardioprotective impacts of a novel fasting mimetic containing spermidine, nicotinamide, palmitoylethanolamide, and oleoylethanolamide: A pilot dose-escalation study in healthy young adult men. Nutr Res. 2024 Dec;132:125-135. doi: 10.1016/j.nutres.2024.10.006. Epub 2024 Oct 23.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spermidine, Nicotinamide and PEA in people with Postprandial Inflammation, run by University of California, Davis 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 6 inclusion and 15 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: finished, as of the sponsor's last update on 23 Aug 2021. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating Plasma Levels of Metabolites (time frame: 1, 2, and 4 hours after ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05017428, which also lists 1 linked publication.
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 23 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.