Evidence map›Paper›PMID 42320787›Full record

Trial reportContemporary clinical trials2026

Protocol for a randomized, controlled trial of a bioactive dietary polyphenol preparation to promote resilience in healthy individuals.

M M Marchidan, M M Rizk, E Karpman, A Lizzano, R Fremont, M F Dobbs, J H Lee, H Irizar, W Lyu, Z Yin and 5 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Contemporary clinical trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

M M MarchidanThe Dennis S Charney, MD, Depression and Anxiety Discovery Center, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
M M RizkThe Dennis S Charney, MD, Depression and Anxiety Discovery Center, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
E KarpmanThe Dennis S Charney, MD, Depression and Anxiety Discovery Center, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
A LizzanoThe Dennis S Charney, MD, Depression and Anxiety Discovery Center, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
R FremontThe Dennis S Charney, MD, Depression and Anxiety Discovery Center, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
M F DobbsThe Dennis S Charney, MD, Depression and Anxiety Discovery Center, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
J H LeeCenters for Biostatistics, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
H IrizarCenters for Biostatistics, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
W LyuNew Use Agriculture and Natural Plant Products Program, Department of Plant Biology and the Rutgers Core Facility for Natural Products and Bioanalysis, New Brunswick, NJ, United States; Department of Medicinal Chemistry, Ernest Mario School of Pharmacy, Rutgers University, Piscataway, NJ, United States.
Z YinNew Use Agriculture and Natural Plant Products Program, Department of Plant Biology and the Rutgers Core Facility for Natural Products and Bioanalysis, New Brunswick, NJ, United States.
Q WuNew Use Agriculture and Natural Plant Products Program, Department of Plant Biology and the Rutgers Core Facility for Natural Products and Bioanalysis, New Brunswick, NJ, United States; Department of Medicinal Chemistry, Ernest Mario School of Pharmacy, Rutgers University, Piscataway, NJ, United States.
J E SimonNew Use Agriculture and Natural Plant Products Program, Department of Plant Biology and the Rutgers Core Facility for Natural Products and Bioanalysis, New Brunswick, NJ, United States; Department of Medicinal Chemistry, Ernest Mario School of Pharmacy, Rutgers University, Piscataway, NJ, United States.
M FerruzziDepartment of Food, Bioprocessing and Nutrition Sciences, Plants for Human Health Institute, North Carolina State University, Kannapolis, NC, United States.
G M PasinettiGeriatrics Research, Education and Clinical Center (GRECC), James J. Peters VA Medical Center, Bronx, NY, United States; The Bronx Veterans Medical Research Foundation, Bronx, NY, USA; VA Sequencing Collaborations United for Research and Epidemiology (seqCURE), James J. Peters VA Medical Center, Bronx, NY, USA. Electronic address: giulio.pasinetti@va.gov.
J W MurroughThe Dennis S Charney, MD, Depression and Anxiety Discovery Center, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States; Nash Family Department of Neuroscience, Icahn School of Medicine at Mount Sinai, New York, NY, United States; VISN 2 Mental Illness Research, Education, and Clinical Centers (MIRECC), James J. Peters VA Medical Center, Bronx, New York, United States. Electronic address: james.murrough@mssm.edu.

Funding

Conduits: Mount Sinai Health System Translational Science HubUL1TR004419 · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · 2025 to 2025
$9.2M
NCATS NIH HHS UL1 TR004419NCCIH NIH HHS U19 AT010835
6 · The paper itself

Abstract

Botanicals and nutritional supplements have gained tremendous popularity as natural approaches to enhancing physical and mental health. However, alongside this trend, there is a growing recognition of the importance of rigorous human studies to validate the absorption, bioavailability, safety and physiological effects of these botanicals. Understanding the effects of these compounds on stress-related outcomes is crucial for ensuring their efficacy and safety to promote stress resilience and overall health. This report describes the design of a parallel arm, randomized, double-blind, placebo-controlled clinical trial to assess the absorption and bioavailability of a 5-week intervention of a daily Bioactive Dietary Polyphenol Preparation (BDPP) consisting of Concord grape juice (CGJ), grape seed polyphenol extract (GSPE), and trans-resveratrol (RSV). Healthy adults (ages 18-55 years) are randomized to receive low, medium, or high doses of BDPP or matching placebo. In addition to pharmacokinetic profiling, the study will evaluate the effects of BDPP on immune function and behavioral measures of stress. The trier social stress test (TSST) will probe acute response to stress. Findings from this trial are intended to lay the foundation for future, larger studies of BDPP and other natural polyphenol-rich products investigating the clinical utility of phenolic supplements for stress resilience and health.

Indexed as

Grape Seed ExtractPolyphenolsResilience, PsychologicalStilbenesStress, PsychologicalAdolescentAdultBiological AvailabilityDietary SupplementsDouble-Blind MethodFemaleFruit and Vegetable JuicesHumansMaleMiddle AgedResearch DesignGrape Seed ExtractPolyphenolsResveratrolStilbenesClinical trialComplementary and alternative medicineImmune systemInflammationMethodologyPolyphenolsStress

Identifiers

PMID42320787
PMCPMC13405406

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.