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Absorption and Digestion Kinetics of Human Metabolites

Primary Purpose

Postprandial Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spermidine
Nicotinamide
PEA
OEA
Wheat Flour
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Postprandial Inflammation

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts 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.

Sites / Locations

  • University of California Davis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Low Dose

Medium Dose

High Dose

Placebo

Arm 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.

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.

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.

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

Outcomes

Primary Outcome Measures

Circulating Plasma Levels of Metabolites
Quantitative plasma concentrations of spermidine, nicotinamide, pamitoylethanolamide, and oleoylethanolamide (in nmol/L).

Secondary Outcome Measures

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

Full Information

First Posted
August 11, 2021
Last Updated
August 17, 2021
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT05017428
Brief Title
Absorption and Digestion Kinetics of Human Metabolites
Official Title
Absorption and Digestion Kinetics of Human Metabolites
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose
Arm Type
Experimental
Arm 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.
Arm Title
Medium Dose
Arm Type
Experimental
Arm 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.
Arm Title
High Dose
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
In this arm the participants are given supplementation with a placebo control consisting of 15g of wheat flour.
Intervention Type
Dietary Supplement
Intervention Name(s)
Spermidine
Other Intervention Name(s)
Primeadine
Intervention Description
Spermidine in the form of a 0.1% spermidine wheat germ extract
Intervention Type
Dietary Supplement
Intervention Name(s)
Nicotinamide
Other Intervention Name(s)
Jarrow Niacinamide
Intervention Description
Nicotinamide given as niacinamide
Intervention Type
Dietary Supplement
Intervention Name(s)
PEA
Other Intervention Name(s)
Nootropics Depot PEA
Intervention Description
Palmitoylethanolamide given at 98% purity
Intervention Type
Dietary Supplement
Intervention Name(s)
OEA
Other Intervention Name(s)
Riduzone
Intervention Description
Oleoylehtanolamide given at 90% purity
Intervention Type
Dietary Supplement
Intervention Name(s)
Wheat Flour
Intervention Description
Wheat flour given as a placebo control
Primary Outcome Measure Information:
Title
Circulating Plasma Levels of Metabolites
Description
Quantitative plasma concentrations of spermidine, nicotinamide, pamitoylethanolamide, and oleoylethanolamide (in nmol/L).
Time Frame
1, 2, and 4 hours after ingestion
Secondary Outcome Measure Information:
Title
Anti-inflammatory capacity of plasma
Description
Ex vivo assessment of the effects of subject plasma on the secretion of pro-inflammatory cytokine TNF-alpha (pg/mL) by primary human macrophage
Time Frame
1, 2, and 4 hours after ingestion

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Participation in the study will be restricted to males. Women will be excluded from the study as the study protocol includes multiple study arms to be completed within a 1 month timeframe. Biological variations caused by the menstrual cycle throughout a single month may cause week to week variability in the absorption, digestion, and metabolism of our metabolites of interest that cannot be controlled for in this small pilot study.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of California Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Absorption and Digestion Kinetics of Human Metabolites

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