Absorption and Digestion Kinetics of Human Metabolites

Completed · Not applicable · Has a placebo group

Conditions studied: Postprandial Inflammation

In brief

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.

Key facts

Study ID

NCT05017428

Run by

University of California, Davis

People needed

5

Starts

2021-04-08

Expected to finish

2021-07-01

Last updated by the study team

2021-08-23

Who can join

Age: 20 and older, up to 40. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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.

Where it is running

• University of California Davis — Davis, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.