The Effects of Mannose Supplementation on Glycosylation and Protein Levels in Human Sera

February 24, 2025 updated by: Jeffrey SoRelle, University of Texas Southwestern Medical Center
The purpose of our study is to investigate the effects of supplemental mannose on sera of humans who are healthy. We will perform proteomics studies to elucidate changes to glycan structure and protein level changes. We hypothesize that we may find that mannose supplies more properly glycosylated protein substrate and helps expedite protein synthesis, that excess mannose leads to alternative glycan structures which confer improved stability, or that there are new sites that become glycosylated after mannose supplementation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will be enrolled and a baseline blood sample taken. Subjects will take mannose supplements for 1 week (3-4 packets of a standard dose in water), then a follow up blood sample will be taken.

Subject blood will be analyzed by proteomic analysis for 1) change in glycan structure or 2) other protein based approaches to measure changes in levels of proteins.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • At least 18 years of age
  • No known medical conditions
  • Taking no medications or nutritional supplements
  • Agree to the study and provide informed consent

Exclusion Criteria:

  • Less than 18 years of age
  • Known medical diagnosis, including pregnancy
  • Presently taking medications and/or nutritional supplements
  • Do not provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mannose supplementation
Mannose supplementation will be given and subjects will be studied at baseline and after treatment.
Dietary supplement: Mannose
Mannose is a sugar monomer that is important in the glycosylation of many proteins. The concentration of mannose in mammalian plasma is ~50-100 μM, which is primarily derived from N-glycan processing. Taking dietary mannose supplements can raise the levels of plasma mannose by 3- to 5-fold. There are currently no known adverse effects of mannose supplementation in humans.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes to glycan structure
Time Frame: ~1 month
Glycopeptide mass spectrometry will be applied to the major glycoproteins present in serum.
~1 month
Change in glycoprotein levels
Time Frame: ~1 month
Standard laboratory methods such as ELISA in either research or clinical laboratory settings (Roche Cobas or similar platform).
~1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Jeffrey SoRelle, M.D., UT Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2024

Primary Completion (Actual)

November 6, 2024

Study Completion (Actual)

November 6, 2024

Study Registration Dates

First Submitted

July 11, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • STU-2024-0127
  • Velos Study Number (Other Identifier: 58400)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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