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Dietary Supplement
Monosaccharide Powder for Healthy Subjects
Phase 1
Recruiting
Led By Emanual Maverakis, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult men/women aged 18-45
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will assess the effects of dietary glycan monomer supplementation on the immune system, especially antibody glycosylation in healthy adults.
Who is the study for?
Healthy adults aged 18-45 with a BMI of 18.5-25 can join this trial. They shouldn't have taken any supplements except basic vitamins, or prescription meds in the last 3 months, and must not be on restrictive diets, consume lots of caffeine or alcohol, or have irregular menstrual cycles.Check my eligibility
What is being tested?
The study is testing if taking a monosaccharide powder supplement affects immune system proteins differently than a placebo (a substance with no active drug). Participants will be randomly assigned to one group or the other without knowing which they're getting.See study design
What are the potential side effects?
Potential side effects are not specified but may include reactions typical for dietary supplements such as digestive discomfort. Since it's a study on healthy individuals, serious side effects are unlikely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 45 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Characterize Immunoglobulin fragment crystallization modifications
Secondary outcome measures
Assess for potential adverse events
Flow cytometry to determine the effect of dietary supplementation on the immune system
Quantification of enzymatic modifications measured in grams by spectrometry
+1 moreTrial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental Supplement 3Experimental Treatment1 Intervention
20 subjects will consume 50 grams of dietary supplement 3 daily for 4 weeks
Group II: Experimental Supplement 2Experimental Treatment1 Intervention
6 subjects will consume 12 grams of dietary supplement 2 daily for 4 weeks
Group III: Experimental Supplement 1Experimental Treatment1 Intervention
6 subjects will consume 12 grams of dietary supplement 1 daily for 4 weeks
Group IV: Placebo Comparator 1Placebo Group1 Intervention
6 subjects will consume 12 grams of placebo dietary supplement daily for 4 weeks
Group V: Placebo Comparator 2Placebo Group1 Intervention
6 subjects will consume 50 grams of placebo dietary supplement daily for 4 weeks
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of California, DavisLead Sponsor
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4,706,947 Total Patients Enrolled
National Institutes of Health (NIH)NIH
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 and younger than 45 years old.I have taken prescription medications in the last 3 months.I am going through or have completed menopause.My parent, sibling, or child has an autoimmune disease.I have a history of autoimmune disease or cancer, except for non-melanoma skin cancer.I am currently taking over-the-counter medications.I have phenylketonuria.I have been diagnosed with galactosemia or a congenital disorder of glycosylation.I have a health condition affecting my heart, lungs, hormones, metabolism, nerves, stomach, blood, or I have an infection.I am unable to give consent for medical procedures.I am between 18 and 45 years old.My menstrual cycles are irregular, occurring more often than every 21 days or lasting longer than 8 days.I have taken supplements like protein, herbal, or vitamins other than multivitamins in the last 3 months.I am 18-45 years old, in good health, and my BMI is between 18.5-25.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Supplement 1
- Group 2: Experimental Supplement 2
- Group 3: Experimental Supplement 3
- Group 4: Placebo Comparator 1
- Group 5: Placebo Comparator 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must potential participants meet to qualify for enrollment in this trial?
"This medical investigation is open to 44 individuals, aged 18-45 and who meet the criteria of general wellness as evidenced by a BMI between 18.5 and 25. All participants must also be in sound physical condition."
Answered by AI
Is this study open to adults aged eighteen and over?
"The age range for this investigation is 18-45, thus participants must be of adult age to participate."
Answered by AI
Has Monosaccharide Powder been given the seal of approval by the FDA?
"Monosaccharide Powder has not yet been tested extensively, so it was rated a 1 due to the Stage of this trial indicating limited data regarding efficacy and safety."
Answered by AI
How many participants is the trial enrolling at this time?
"Affirmative. The clinical trial record on the government website signposts that recruitment for this research endeavour is active, with plans to involve 44 patients at a solitary location since its posting date of 1/1/2023 and last update on 5/3/2022."
Answered by AI
Is this research project still accepting participants?
"Correct. According to the clinicaltrials.gov portal, this medical trial was first shared on January 1st 2023 and is actively seeking enrolment from 44 individuals at a single location. The information has been updated as recently as May 3rd 2022."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
University of California, Davis Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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