NCT06507735

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 29, 2024

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2024

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

8 days

First QC Date

July 11, 2024

Last Update Submit

February 24, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Changes to glycan structure

    Glycopeptide mass spectrometry will be applied to the major glycoproteins present in serum.

    ~1 month

  • Change in glycoprotein levels

    Standard laboratory methods such as ELISA in either research or clinical laboratory settings (Roche Cobas or similar platform).

    ~1 month

Study Arms (1)

Mannose supplementation

EXPERIMENTAL

Mannose supplementation will be given and subjects will be studied at baseline and after treatment.

Dietary Supplement: Mannose

Interventions

MannoseDIETARY_SUPPLEMENT

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.

Mannose supplementation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

Mannose

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Jeffrey SoRelle, M.D.

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 11, 2024

First Posted

July 18, 2024

Study Start

October 29, 2024

Primary Completion

November 6, 2024

Study Completion

November 6, 2024

Last Updated

February 27, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations