Clinical trial NCT05017428: Absorption and Digestion Kinetics of Human Metabolites
Official title: Absorption and Digestion Kinetics of Human Metabolites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Inflammation
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 5
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Circulating Plasma Levels of Metabolites
timeFrame: 1, 2, and 4 hours after ingestion
Secondary outcomes:
measure: Anti-inflammatory capacity of plasma
timeFrame: 1, 2, and 4 hours after ingestion
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California Davis
state: California
Study officials:
References: