Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Placebo | Placebo Comparator | In this arm the participants are given supplementation with a placebo control consisting of 15g of wheat flour. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spermidine | Dietary Supplement | Spermidine in the form of a 0.1% spermidine wheat germ extract |
|
| Measure | Description | Time Frame |
|---|---|---|
| Circulating Plasma Levels of Metabolites | Quantitative plasma concentrations of spermidine, nicotinamide, pamitoylethanolamide, and oleoylethanolamide (in nmol/L). | 1, 2, and 4 hours after ingestion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1, 2, and 4 hours after ingestion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Participation in the study will be restricted to males. Women will be excluded from the study as the study protocol includes multiple study arms to be completed within a 1 month timeframe. Biological variations caused by the menstrual cycle throughout a single month may cause week to week variability in the absorption, digestion, and metabolism of our metabolites of interest that cannot be controlled for in this small pilot study.
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis | Davis | California | 95616 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39549554 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013095 | Spermidine |
| D009536 | Niacinamide |
| D005433 | Flour |
| ID | Term |
|---|---|
| D011700 | Putrescine |
| D015317 | Biogenic Polyamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Nicotinamide | Dietary Supplement | Nicotinamide given as niacinamide |
|
|
| PEA | Dietary Supplement | Palmitoylethanolamide given at 98% purity |
|
|
| OEA | Dietary Supplement | Oleoylehtanolamide given at 90% purity |
|
|
| Wheat Flour | Dietary Supplement | Wheat flour given as a placebo control |
|
| D009930 |
| Organic Chemicals |
| D011073 | Polyamines |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |