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Completed

NCT Number: NCT05017428

Absorption and Digestion Kinetics of Human Metabolites

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis

Davis, California, 95616, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spermidine

Dietary Supplement

Spermidine in the form of a 0.1% spermidine wheat germ extract

Other names: Primeadine

Nicotinamide

Dietary Supplement

Nicotinamide given as niacinamide

Other names: Jarrow Niacinamide

PEA

Dietary Supplement

Palmitoylethanolamide given at 98% purity

Other names: Nootropics Depot PEA

OEA

Dietary Supplement

Oleoylehtanolamide given at 90% purity

Other names: Riduzone

Wheat flour

Dietary Supplement

Wheat flour given as a placebo control

Primary outcomes

  1. 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).

Secondary outcomes

  1. Anti-inflammatory capacity of plasma

    Time frame: 1, 2, and 4 hours after ingestion

    Ex vivo assessment of the effects of subject plasma on the secretion of pro-inflammatory cytokine TNF-alpha (pg/mL) by primary human macrophage

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 23, 2021
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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