Healthy IndividualsPhase 1NCT04466761
Ascending Glycan Dietary Supplementation in Healthy Adults
A Phase 1 study testing Monosaccharide Powder in people with Healthy Individuals, run by University of California, Davis at 1 site in United States.
Trial summary
The investigators will conduct a parallel-group, placebo-controlled, randomized, double-blind ascending dose Phase I study of dietary supplementation in healthy individuals to evaluate safety and to determine the pharmacologically effective dose (ED). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- Monosaccharide Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2022to 6 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patients must be 18-45 years of age
- Patients who are in general good health
- Body Mass Index (BMI) range of 18.5-25
- All individuals must have the ability to provide inform consent
Who cannot join
- Women who are pregnant, actively nursing, or pregnant 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
- Past medical history of an autoimmune condition or malignancy, excluding non-melanoma skin cancer
- Individuals with first degree relative with history of an autoimmune condition
Show all 26Show fewer
- Individuals with cardiovascular, pulmonary, reproductive, endocrine, metabolic, neurologic, gastrointestinal, hematologic, or infectious diseases of any kind
- Individuals with diagnosis of galactosemia or congenital disorders of glycosylation
- Individuals with phenylketonuria
- Individuals currently taking prescription medications, or have taken prescription medications within the last 3 months
- Individuals currently taking over the counter medications
- Individuals currently taking or 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 prior history of severe food or drug allergic reactions
- Individuals with a diagnosis of type I or II diabetes mellitus
- Individuals with allergic reaction or adverse reaction to shellfish, N-acetyl glucosamine, galactose, or Spirulina/chlorella/algae supplements
- 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 to whom any of the following dietary habits or characteristics apply (the following exclusion criteria are placed to minimize variability in diet in our 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
- On a carbohydrate-restricted or "Paleo" diet
- Calorie-restricted diet (less than 20%-25% of maintenance calories)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Medical Center
Sacramento, California, 95630
About this study
Official title: Phase I Ascending Dose Study of Dietary Supplementation With Glycan Monomers in Healthy Adults
The investigators will conduct a parallel-group, placebo-controlled, randomized, double-blind ascending dose Phase I study of dietary supplementation in healthy individuals to evaluate safety and to determine the pharmacologically effective dose (ED).
- Conditions
- Healthy Individuals
- Being tested
- Monosaccharide Powder, Placebo Comparator
- Keywords
- Healthy Adults, Dietary supplements
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 ComparatorOther
Placebo (cellulose powder).
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Cohort 1-4 | Experimental | 60% of subjects per cohort will consume 30-90 grams of dietary supplement daily for 4 weeks, with each successive cohort dosage increasing according to a Fibonacci dose escalation. Receives: Dietary Supplement: Monosaccharide Powder |
| Placebo: Cohort 1-4 | Placebo comparator | 40% of subjects per cohort will consume 30-90 grams of daily placebo for 4 weeks with each successive cohort dosage increasing in parallel to the experimental arm. Receives: Other: 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
Identify the maximum effective dose
Identify maximum effective dose of dietary supplement in grams/day.
Measured: 16 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 Jul 2020
- Study start23 Jun 2022
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Why it stopped: The IRB closed the protocol. PI failed to submit study for continuing review.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emanual Maverakis, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466761
- Sponsor's protocol ID
- 1516913
- Status last verified
- Nov 2024
- First submitted
- 26 Jun 2020
- Last updated
- 12 Nov 2024
- 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 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Ascending Dose Study of Dietary Supplementation With Glycan Monomers in Healthy Adults
- ClinicalTrials.gov ID
- NCT04466761
- Acronym / sponsor ID
- 1516913
- Conditions
- Healthy Individuals
- Keywords
- Healthy Adults, Dietary supplements
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The IRB closed the protocol. PI failed to submit study for continuing review.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 10 Jul 2020 (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.
The investigators will conduct a parallel-group, placebo-controlled, randomized, double-blind ascending dose Phase I study of dietary supplementation in healthy individuals to evaluate safety and to determine the pharmacologically effective dose (ED).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Cohort 1-4 | Experimental | Dietary Supplement: Monosaccharide Powder60% of subjects per cohort will consume 30-90 grams of dietary supplement daily for 4 weeks, with each successive cohort dosage increasing according to a Fibonacci dose escalation. |
| Placebo: Cohort 1-4 | Placebo comparator | Other: Placebo Comparator40% of subjects per cohort will consume 30-90 grams of daily placebo for 4 weeks with each successive cohort dosage increasing in parallel to the experimental arm. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients must be 18-45 years of age
- Patients who are in general good health
- Body Mass Index (BMI) range of 18.5-25
- All individuals must have the ability to provide inform consent
Key exclusion criteria (26 listed)
- Women who are pregnant, actively nursing, or pregnant 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
- Past medical history of an autoimmune condition or malignancy, excluding non-melanoma skin cancer
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: Cohort 1-4 |
| Placebo ComparatorPlacebo (cellulose powder). | Other | Placebo: Cohort 1-4 |
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.
Identify the maximum effective dose
Time frame: 16 Weeks
Identify maximum effective dose of dietary supplement in grams/day.
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
The study was stopped early (reason given: The IRB closed the protocol. PI failed to submit study for continuing review.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Healthy Individuals
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
Histamine, Cowhage
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
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. This study is not recruiting at the moment.
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 Individuals, 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 4 inclusion and 26 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: stopped early, as of the sponsor's last update on 12 Nov 2024. 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?
The study was stopped early (reason given: The IRB closed the protocol. PI failed to submit study for continuing review.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize Immunoglobulin fragment crystallization modifications (time frame: 4 Weeks). The study lists 2 primary outcomes in all. 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 12 Nov 2024.