HealthyPhase 1NCT05040204
The Effects of Dietary Supplementation on Serum Protein Glycosylation
A Phase 1 study testing Monosaccharide Powder in people with Healthy, run by University of California, Davis at 1 site in United States.
Trial summary
Two randomized double-blind placebo-controlled clinical studies to assess the effects of dietary glycan monomer supplementation on the immune system, especially antibody glycosylation in healthy adults. Immune profiling and glycoproteomics will be performed on serum isolated at these same time points. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Monosaccharide Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2022to 22 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult men/women (age 18-45) who are in general good health with Body Mass Index (BMI) range of 18.5-25
Who cannot join
- Adults younger than 18 or older than 45 years of age
- Women who are pregnant, actively nursing or have had a pregnancy within the last year
- Women who are peri-menopausal or post-menopausal
- Women with irregular menstrual cycles (more frequently than every 21 days or lasts longer than 8 days. Missed, early, or late periods are also considered signs of an irregular cycle)
- Women on hormonal contraception, including birth control, hormonal intrauterine device, or contraceptive implant
- Individuals with past medical history of an autoimmune condition or malignancy, excluding non-melanoma skin cancer
Show all 31Show fewer
- Individuals with cardiovascular, pulmonary, reproductive, endocrine, metabolic, neurologic, gastrointestinal, hematologic, or infectious diseases of any type
- Individuals with diagnosis of galactosemia or congenital disorders of glycosylation
- Individuals with phenylketonuria
- Individuals currently taking prescription medications, or who have taken prescription medications within the last 3 months
- Individuals currently taking over-the-counter medications
- Individuals currently taking or who have taken supplements including herbal, protein or vitamin supplements in the last 3 months (e.g. whey protein, St. John's Wort, green tea supplements, biotin, creatine supplements), excluding multivitamins or essential vitamins
- Individuals with BMI less than 18.5 or greater than 25
- Individuals with prior history of severe food or drug allergic reactions
- Individuals with allergic reaction or adverse reaction to shellfish, N-acetylglucosamine, galactose, Spirulina/chlorella/algae supplements, or arabinose containing compounds/foods/supplements
- Individuals with first-degree relative with history of an autoimmune condition
- Individuals with social history of current use of tobacco, alcohol or other drugs
- Individuals with dietary restrictions (vegetarians are permitted to participate in the study) or atypical exercise patterns, or to whom any of the following dietary habits or characteristics apply (the following exclusion criteria are placed to minimize variability in diet/exercise patterns in our pilot study population):
- Actively dieting or trying to lose weight
- Vegan diet
- Consume equal to or greater than 2 cups of tea a day
- Consume equal to or greater than 4 cups of coffee a day
- Consume equal to or greater than 3 cups of fruit juice a day
- Practice intensive exercise patterns (marathon training, workouts >4 hours a day)
- Consume soda or energy drinks of any amount
- Consume fast food equal to or greater than 5 days per week
- Consume greater than one serving of alcohol per day
- (1 serving of wine = 6 oz, 1 serving of beer = 12 oz, 1 serving of spirits = 1 oz)
- On a carbohydrate-restricted or "Paleo" diet, or calorie-restricted diet (less than 20-25% of maintenance calories)
- Adults unable to consent
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Davis Medical Center
Sacramento, California, 95816
Monica Tran, BS, 916-551-2634, montran@ucdavis.edu
Emanual Maverakis, MD
About this study
Two randomized double-blind placebo-controlled clinical studies to assess the effects of dietary glycan monomer supplementation on the immune system, especially antibody glycosylation in healthy adults. Immune profiling and glycoproteomics will be performed on serum isolated at these same time points.
- Conditions
- Healthy
- Being tested
- Monosaccharide Powder, Placebo Comparator
- Keywords
- dietary supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monosaccharide PowderDietary supplement
Monosaccharide powder dissolved in water.
Placebo ComparatorDietary supplement
Placebo (glucose powder)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Supplement 1 | Experimental | 6 subjects will consume 12 grams of dietary supplement 1 daily for 4 weeks Receives: Dietary Supplement: Monosaccharide Powder |
| Experimental Supplement 2 | Experimental | 6 subjects will consume 12 grams of dietary supplement 2 daily for 4 weeks Receives: Dietary Supplement: Monosaccharide Powder |
| Experimental Supplement 3 | Experimental | 20 subjects will consume 50 grams of dietary supplement 3 daily for 4 weeks Receives: Dietary Supplement: Monosaccharide Powder |
| Placebo Comparator 1 | Placebo comparator | 6 subjects will consume 12 grams of placebo dietary supplement daily for 4 weeks Receives: Dietary Supplement: Placebo Comparator |
| Placebo Comparator 2 | Placebo comparator | 6 subjects will consume 50 grams of placebo dietary supplement daily for 4 weeks Receives: Dietary Supplement: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize Immunoglobulin fragment crystallization modifications
Use mass spectrometry and RNA sequencing from subject blood samples to characterize site specific glycosylation on Immunoglobulin A, Immunoglobulin M, and Immunoglobulin G.
Measured: 4 Weeks
Secondary outcomes (4)
Assess for potential adverse events
Monitor symptoms, severity, and duration of adverse events.
Measured: 2 months after first dose
Quantification of enzymatic modifications measured in grams by spectrometry
The investigators will measure enzymatic changes on glycoproteins in the immune system by spectrometry, i.e., these changes will be measured in grams. Spectometry will allow the investigators to quantify these changes in small detail, and therefore give a better idea of how supplementation can change enzymatic process that then affect the structure, and mass, of glycoproteins.
Measured: 6 months
Flow cytometry to determine the effect of dietary supplementation on the immune system
Perform flow cytometry on subject blood samples to determine the effect of dietary supplement on immune system. For example, the investigators will note changes to immune cell pro-inflammatory and anti-inflammatory cytokine clusters as translated proteins (measured as height and area of cytokine intensity).
Measured: 6 months
Transcriptome analysis to determine the effect of dietary supplementation on the immune system
Perform transcriptome analysis on subject blood samples to determine the effect of dietary supplement on immune system. For example, the investigators will note changes to immune cell pro-inflammatory and anti-inflammatory cytokine clusters as RNA (measure on a logarithmic scale per number of reads) to determine the effects of supplementation on both gene transcription and translation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start23 Jun 2022
- Primary completion22 Nov 2026 (estimated)
- Study completion22 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Emanual Maverakis, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040204
- Sponsor's protocol ID
- 949221
- Other IDs
- 1K24AR077313-01A1
- Status last verified
- May 2026
- First submitted
- 1 Sep 2021
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dietary Supplementation on Serum Protein Glycosylation
- ClinicalTrials.gov ID
- NCT05040204
- Acronym / sponsor ID
- 949221
- Conditions
- Healthy
- Keywords
- dietary supplement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 22 Nov 2026 (estimated)
- Study completion
- 22 Nov 2026 (estimated)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two randomized double-blind placebo-controlled clinical studies to assess the effects of dietary glycan monomer supplementation on the immune system, especially antibody glycosylation in healthy adults. Immune profiling and glycoproteomics will be performed on serum isolated at these same time points.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Experimental Supplement 1 | Experimental | Dietary Supplement: Monosaccharide Powder6 subjects will consume 12 grams of dietary supplement 1 daily for 4 weeks |
| Experimental Supplement 2 | Experimental | Dietary Supplement: Monosaccharide Powder6 subjects will consume 12 grams of dietary supplement 2 daily for 4 weeks |
| Experimental Supplement 3 | Experimental | Dietary Supplement: Monosaccharide Powder20 subjects will consume 50 grams of dietary supplement 3 daily for 4 weeks |
| Placebo Comparator 1 | Placebo comparator | Dietary Supplement: Placebo Comparator6 subjects will consume 12 grams of placebo dietary supplement daily for 4 weeks |
| Placebo Comparator 2 | Placebo comparator | Dietary Supplement: Placebo Comparator6 subjects will consume 50 grams of placebo dietary supplement daily for 4 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult men/women (age 18-45) who are in general good health with Body Mass Index (BMI) range of 18.5-25
Key exclusion criteria (31 listed)
- Adults younger than 18 or older than 45 years of age
- Women who are pregnant, actively nursing or have had a pregnancy within the last year
- Women who are peri-menopausal or post-menopausal
- Women with irregular menstrual cycles (more frequently than every 21 days or lasts longer than 8 days. Missed, early, or late periods are also considered signs of an irregular cycle)
- Women on hormonal contraception, including birth control, hormonal intrauterine device, or contraceptive implant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monosaccharide PowderMonosaccharide powder dissolved in water. | Dietary supplement | Experimental Supplement 1, Experimental Supplement 2, Experimental Supplement 3 |
| Placebo ComparatorPlacebo (glucose powder) | Dietary supplement | Placebo Comparator 1, Placebo Comparator 2 |
Primary outcome
Characterize Immunoglobulin fragment crystallization modifications
Time frame: 4 Weeks
Use mass spectrometry and RNA sequencing from subject blood samples to characterize site specific glycosylation on Immunoglobulin A, Immunoglobulin M, and Immunoglobulin G.
4 secondary outcomes
Assess for potential adverse events
Time frame: 2 months after first dose
Quantification of enzymatic modifications measured in grams by spectrometry
Time frame: 6 months
Flow cytometry to determine the effect of dietary supplementation on the immune system
Time frame: 6 months
Transcriptome analysis to determine the effect of dietary supplementation on the immune system
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Learn more or sign up for the study here!Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emanual Maverakis, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Monosaccharide Powder in people with Healthy, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emanual Maverakis, MD (916-551-2635, emaverakis@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize Immunoglobulin fragment crystallization modifications (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.