Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2021-04-08
2021-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Low Dose
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.
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
Medium Dose
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.
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
High Dose
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.
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
Placebo
In this arm the participants are given supplementation with a placebo control consisting of 15g of wheat flour.
Wheat Flour
Wheat flour given as a placebo control
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
40 Years
MALE
Yes
Sponsors
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University of California, Davis
OTHER
Responsible Party
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Angela Zivkovic, PhD
Associate Professor
Locations
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University of California Davis
Davis, California, United States
Countries
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References
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Rhodes CH, Hong BV, Tang X, Weng CY, Kang JW, Agus JK, Lebrilla CB, Zivkovic AM. Absorption, anti-inflammatory, antioxidant, and cardioprotective impacts of a novel fasting mimetic containing spermidine, nicotinamide, palmitoylethanolamide, and oleoylethanolamide: A pilot dose-escalation study in healthy young adult men. Nutr Res. 2024 Dec;132:125-135. doi: 10.1016/j.nutres.2024.10.006. Epub 2024 Oct 23.
Other Identifiers
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1725738
Identifier Type: -
Identifier Source: org_study_id
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