Clinical trial NCT05040204: The Effects of Dietary Supplementation on Serum Protein Glycosylation
Official title: The Effects of Dietary Supplementation on Serum Protein Glycosylation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Keywords: dietary supplement
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2021-09-10
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Adult men/women (age 18-45) who are in general good health with Body Mass Index (BMI) range of 18.5-25

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Characterize Immunoglobulin fragment crystallization modifications
timeFrame: 4 Weeks
Secondary outcomes:
measure: Assess for potential adverse events
timeFrame: 2 months after first dose
measure: Quantification of enzymatic modifications measured in grams by spectrometry
timeFrame: 6 months
measure: Flow cytometry to determine the effect of dietary supplementation on the immune system
timeFrame: 6 months
measure: Transcriptome analysis to determine the effect of dietary supplementation on the immune system
timeFrame: 6 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Emanual Maverakis, MD
role: PRINCIPAL_INVESTIGATOR
References: