Summary

Eligibility
for people ages 18-45 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UC Davis
Dates
study started
estimated completion
Principal Investigator
by Emanual Maverakis, MD (ucdavis)

Description

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.

Keywords

Healthy dietary supplement Monosaccharide Powder

Eligibility

You can join if…

Open to people ages 18-45

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

You CAN'T join if...

  • 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

Location

  • University of California, Davis Medical Center accepting new patients
    Sacramento California 95816 United States

Lead Scientist at University of California Health

  • Emanual Maverakis, MD (ucdavis)
    Professor, Dermatology. Authored (or co-authored) 173 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
Links
Learn more or sign up for the study here!
ID
NCT05040204
Phase
Phase 1
Study Type
Interventional
Participants
Expecting 44 study participants
Last Updated