Absorption and Digestion Kinetics of Human Metabolites

University of California (UC) Davis

Status: Completed

Conditions: Postprandial Inflammation

Treatments: Dietary Supplement: Wheat Flour; Dietary Supplement: Spermidine; Dietary Supplement: OEA; Dietary Supplement: PEA; Dietary Supplement: Nicotinamide

Study type: Interventional

Funder types: Other

Identifiers

NCT05017428

1725738

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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5 participants in 4 patient groups, including a placebo group

Low Dose

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Nicotinamide

Dietary Supplement: PEA

Dietary Supplement: OEA

Dietary Supplement: Spermidine

Medium Dose

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Nicotinamide

Dietary Supplement: PEA

Dietary Supplement: OEA

Dietary Supplement: Spermidine

High Dose

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Nicotinamide

Dietary Supplement: PEA

Dietary Supplement: OEA

Dietary Supplement: Spermidine

Placebo

Placebo Comparator group

Description:

In this arm the participants are given supplementation with a placebo control consisting of 15g of wheat flour.

Treatment:

Dietary Supplement: Wheat Flour