---
title: "NG00133 – Safety and pharmacokinetics of a highly bioavailable resveratrol preparation (JOTROL <sup>TM</sup>)"
id: "3741"
type: "dataset"
slug: "ng00133"
published_at: "2023-05-27T15:43:00+00:00"
modified_at: "2026-09-08T20:47:34+00:00"
url: "https://dss.niagads.org/datasets/ng00133/"
markdown_url: "https://dss.niagads.org/datasets/ng00133.md"
taxonomy_dataset_categories:
  - "AD"
  - "Data Type"
  - "Disease"
  - "Open Access"
  - "Summary Statistics"
---

## Overview

#### Description

Resveratrol exhibits a wide range of biological properties, including anti-glycation, antioxidant, anti-inflammation, neuroprotective (including against advanced dementia and Alzheimer’s disease), anti-cancer, and anti-aging activity in experimental models. Unfortunately, this compound exhibits low bioavailability and solubility, requiring large doses that can cause nausea and GI distress. JOTROLTM is a micellar 10% resveratrol solubilization formulation that is thought to increase bioavailability of resveratrol via lymphatic system absorption. Jupiter Neurosciences (formerly Jupiter Orphan Therapeutics; “Jupiter”) is pursuing the use of resveratrol in mucopolysaccharidosis type 1 (MPS 1), Friedreich’s Ataxia, and Alzheimer’s Disease/Mild Cognitive Impairment.

This paper describes a first in human study (FIH) to evaluate the bioavailability of resveratrol after ascending, single oral doses up to 700 mg resveratrol as JOTROLTM. After a single 500 mg dose of JOTROLTM, a Cmax of 455 ng/mL was observed, vs. 85 ng/mL Cmax after a 1g encapsulated dose[2]and 1942 ng/mL after a 2.5 g micronized dose[3]. In this study, resveratrol exposures (AUCs and Cmax) increased with increasing doses. This increase appears to be higher than dose-proportional for AUC0-t and Cmax. Resveratrol and its three major conjugates accounted for 40 to 55% of the dose in urine, consistent with a high extent of absorption, but <1% of drug related material was intact relative to key metabolites in plasma and urine. Studies in Alzheimer’s patients and in MPS 1 are currently in development to test the effect this improved bioavailability has on those patient populations. (Clintrials.gov, [NCT04668274](https://clinicaltrials.gov/show/NCT04668274)
, 12/16/2020, [https://clinicaltrials.gov/ct2/show/NCT04668274](https://clinicaltrials.gov/ct2/show/NCT04668274)
).

There are 3 study reports available with this dataset:

1. Plasma levels of resveratrol and 3 key metabolites- a table from the complete clinical study report that contains Measured Values of Resveratrol, Resveratrol Sulfate, Resveratrol 3-Glucuronide and Resveratrol 4-Glucuronide in Human Plasma Samples.
2. Urinary excretion data of resveratrol and 3 key metabolites- a table from the complete clinical study report that contains Measured Values of Resveratrol, Resveratrol Sulfate, Resveratrol 3-Glucuronide and Resveratrol 4-Glucuronide in Human Urine Samples.
3. PK summary statistics in plasma and urine- a table from the complete clinical study report that contains Descriptive Statistics of Plasma Pharmacokinetic Parameters by Treatment for JOTROL (Resveratrol) and Metabolites – PK Population.

#### Available Filesets

| Name | Accession | Latest Release | Description |
| --- | --- | --- | --- |
| Suppl_1_plasma, Suppl_2_urine, and Suppl_3_PK_Summary | fsa000043 | NG00133.v1 | Plasma, Urine and PK Summary |

View the [File Manifest](https://st1.niagads.org/portal/download-public/NG00133.v1/fm)
 for a full list of files released in this dataset.

## Related Studies

- [sa000029 - Safety and pharmacokinetics of a highly bioavailable resveratrol preparation (JOTROL TM)](https://dss.niagads.org/studies/sa000029/) Resveratrol exhibits a wide range of biological properties, including anti-glycation, antioxidant, anti-inflammation, neuroprotective (including against advanced dementia and Alzheimer’s disease), anti-cancer, and anti-aging activity in experimental models. Unfortunately, this compound… [Learn more](https://dss.niagads.org/studies/sa000029/)

## Acknowledgement

### Acknowledgment statement for any data distributed by NIAGADS:

Data for this study were prepared, archived, and distributed by the National Institute on Aging Alzheimer's Disease Data Storage Site (NIAGADS) at the University of Pennsylvania (U24-AG041689), funded by the National Institute on Aging.

Use the study-specific acknowledgement statements below (as applicable):

### For investigators using any data from this dataset:

Please cite/reference the use of NIAGADS data by including the accession [NG00133](https://archive.niagads.org/datasets/NG00133)
.

### For investigators using Safety and pharmacokinetics of a highly bioavailable resveratrol preparation (sa000029) data:

The Clinical Study aspects of this report were supported by a research grant from the US National Institute on Aging, Grant 1 R44 AG067907-01A1.

## Publications

- Kemper C. **Safety and pharmacokinetics of a highly bioavailable resveratrol preparation (JOTROL (TM)).***AAPS open. 2022.*[PubMed link](https://pubmed.ncbi.nlm.nih.gov/35789594/)

### Total number of participants: 0