C04 12444726Q0078 SOW.pdf

STATEMENT OF WORK (SOW)

Project Metabolomic links of blueberry intake and cognitive function

General Information

1.0 Scope of Work

The USDA Agricultural Research Service (ARS) at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University seeks to investigate metabolomic changes linked to cognitive improvement following blueberry consumption. This project involves analyzing 58 human plasma samples collected at baseline and after 90 days, with profiling of more than 2,500 metabolites. All metabolites will undergo comprehensive quality control and normalization.

The analysis requires access to proprietary metabolite libraries and annotation algorithms, as well as demonstrated expertise in human plasma metabolomics. Comparative analyses will be conducted between the blueberry group (n=15) and the placebo group (n=14), and between baseline and 90‑day measurements. The objective is to identify metabolomic signatures associated with blueberry intake that may underpin observed enhancements in cognitive function.

Goals and Objectives include:

• Accurate measurement of over 2500 metabolites using targeted or untargeted or broad-spectrum profiling.

• Comparison of metabolite abundance between treatment and placebo groups at both study timepoints.

• Identification of metabolic changes from baseline to 90 days.

• Exploratory linkage of metabolite profiles to cognitive function measurements provided by ARS.

2.0 Background

The USDA Agricultural Research Service carried out a controlled human nutrition study to examine how regular blueberry consumption influences metabolic profiles. Plasma samples were collected from participants at baseline and again after 90 days, following randomization to either a blueberry treatment group or a placebo group. The primary goal of the research is to identify metabolite patterns associated with changes in cognitive function.

We are seeking a company capable of accurately quantifying more than 2,500 metabolites per sample and with extensive prior experience analyzing human plasma. High-quality analytical service and data reliability are essential requirements.

Contractor Requirements

3.0 Technical Requirements / Tasks

• Accurate measurement of over 2500 metabolites in human plasma samples.

• Plasma samples should be profiled using Ultrahigh Performance Liquid Chromatography-Tandem Mass Spectroscopy system. (UPLC-MS/MS)

• A relative concentration profile of all structurally named small-molecule entities, which can include both endogenous compounds, xenobiotics, and their metabolites, extracted from the samples and detected by metabolomic platform.

• Normalized concentration of each metabolite across all the samples.

• Access to proprietary metabolite libraries and annotation algorithms.

• Prior extensive experience analyzing human plasma samples.

• Spectral Data for client provided samples in 300 ul format. Excludes Spectral Data for

QC samples. Includes access and ability to download Spectral Data for twelve (12) months following delivery.

• One Matrix Study (Data Only).

• Relative quantitation for unnamed compounds with specific identifiers, i.e. X-12345, identified in the samples provided by the client to the vendor. Only compounds identified will be included. No tentative details about unnamed compounds are needed.

• Default Disposition: Unused samples should be returned to USDA ARS 90 days after project completion.

4.0 Government Furnished

• USDA ARS will prepare 58 plasma samples for this Study in accordance with vendor’s

Standard Sample Preparation.

• USDA ARS will ship all the samples to the company by following Shipping Procedures.

• USDA ARS will complete the sample manifest template (.csv file) provided by the company and in accordance with guidance sent by the vendor, including necessary information (e.g., balancing schemes, sample run order, or metadata for statistical comparisons.

5.0 Deliverables / Schedule

The Contractor shall provide the following deliverables:

• Sample processing and QC summary report.

• Accurate measurements of 2500 metabolites.

• Original concentrations and normalized concentrations of each metabolite across all the samples.

• A complete matrix of identified metabolites and their abundances.

• Statistical tables showing group differences, fold-changes, significance levels, and adjusted p-values.

• Multivariate analysis outputs (e.g., PCA, PLS-DA).

• Correlation outputs linking metabolites with cognitive outcomes.

• Final summary report with methods, findings, limitations, and interpretation notes.

• All electronic deliverables must comply with Section 508 accessibility standards.

6.0 Travel

No travel is required.

7.0 Contractor’s Key Personnel

The Contractor must demonstrate:

• Expertise in high-throughput metabolomic profiling.

• Established LC-MS and GC-MS analytical platforms with validated QA/QC procedures.

• Access to proprietary metabolite libraries and annotation algorithms.

• Prior experience analyzing human plasma samples.

8.0 Security Requirements

• All data shall be treated as confidential research data.

• No identifiable information will be shared with the Contractor.

• The Contractor may not distribute or disclose any data without written ARS authorization.

• Secure file transfer methods must be used for electronic deliverables.

9.0 Data Rights

The USDA ARS holds all rights to the data generated in this project. Vendors may not transfer or publish any data without USDA ARS authorization.

10.0 Section 508 – Electronic and Information Technology Standards All electronic deliverables provided under this agreement must comply with Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. § 794d), as amended, and the U.S. Access Board’s EIT Accessibility Standards (36 CFR Part 1194).

The company shall ensure that all electronic documents, data files, reports, and digital communications delivered to ARS meet applicable Section 508 requirements, including but not limited to:

• Accessible PDF, Excel, Word, or other document formats.

• Proper tagging, reading order, and alternative text for figures, charts, or graphics where applicable.

• Use of accessible table structures, headings, and labels to support screen-reader navigation.

• Ensuring that color-dependent information is also conveyed textually.

• Ensuring that all data visualizations (e.g., PCA plots, volcano plots) meet accessibility requirements or are accompanied by equivalent text descriptions.

If full accessibility cannot be met due to scientific data constraints or platform-generated limitations, the company shall provide:

• An explanation of the accessibility exception, and equivalent alternative formats or descriptions enabling ARS personnel with disabilities to interpret the information.

All materials will be reviewed by ARS for Section 508 compliance prior to acceptance.