Absorption and Digestion Kinetics of Human Metabolites

Postprandial Inflammation Clinical Trial

Official title:

Absorption and Digestion Kinetics of Human Metabolites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05017428
• Other study ID #: 1725738
• Status: Completed
• Phase: N/A
• Start date: April 8, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: August 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Postprandial Inflammation

Intervention

Dietary Supplement:
• Spermidine
Spermidine in the form of a 0.1% spermidine wheat germ extract
• Nicotinamide
Nicotinamide given as niacinamide
• PEA
Palmitoylethanolamide given at 98% purity
• OEA
Oleoylehtanolamide given at 90% purity
• Wheat Flour
Wheat flour given as a placebo control

Locations

Country	Name	City	State
United States	University of California Davis	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating Plasma Levels of Metabolites	Quantitative plasma concentrations of spermidine, nicotinamide, pamitoylethanolamide, and oleoylethanolamide (in nmol/L).	1, 2, and 4 hours after ingestion
Secondary	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