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

NCT ID: NCT06507735

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-29

Study Completion Date

2024-11-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Physiological Stress

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Mannose supplementation

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

Group Type EXPERIMENTAL

Mannose

Intervention Type DIETARY_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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey SoRelle

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey SoRelle, M.D.

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

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University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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Velos Study Number

Identifier Type: OTHER

Identifier Source: secondary_id

STU-2024-0127

Identifier Type: -

Identifier Source: org_study_id

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