The Effects of Dietary Supplementation on Serum Protein Glycosylation
NCT ID: NCT05040204
Last Updated: 2025-12-02
Study Results
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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RECRUITING
PHASE1
44 participants
INTERVENTIONAL
2022-06-23
2026-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Experimental Supplement 1
6 subjects will consume 12 grams of dietary supplement 1 daily for 4 weeks
Monosaccharide Powder
Monosaccharide powder dissolved in water.
Experimental Supplement 2
6 subjects will consume 12 grams of dietary supplement 2 daily for 4 weeks
Monosaccharide Powder
Monosaccharide powder dissolved in water.
Experimental Supplement 3
20 subjects will consume 50 grams of dietary supplement 3 daily for 4 weeks
Monosaccharide Powder
Monosaccharide powder dissolved in water.
Placebo Comparator 1
6 subjects will consume 12 grams of placebo dietary supplement daily for 4 weeks
Placebo Comparator
Placebo (glucose powder)
Placebo Comparator 2
6 subjects will consume 50 grams of placebo dietary supplement daily for 4 weeks
Placebo Comparator
Placebo (glucose powder)
Interventions
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Monosaccharide Powder
Monosaccharide powder dissolved in water.
Placebo Comparator
Placebo (glucose powder)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
* 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
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Emanual Maverakis, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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University of California, Davis Medical Center
Sacramento, California, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Learn more or sign up for the study here!
Other Identifiers
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949221
Identifier Type: -
Identifier Source: org_study_id
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