Summary

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

Description

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).

Official Title

Phase I Ascending Dose Study of Dietary Supplementation With Glycan Monomers in Healthy Adults

Keywords

Healthy Individuals, Healthy Adults, Dietary supplements, Monosaccharide Powder

Eligibility

You can join if…

Open to people ages 18-45

  • 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

You CAN'T join if...

  • 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
  • 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)

Location

  • University of California, Davis Medical Center accepting new patients
    Sacramento California 95630 United States

Lead Scientist at University of California Health

  • Emanual Maverakis, MD (ucdavis)
    Professor, Dermatology, School of Medicine. Authored (or co-authored) 217 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT04466761
Phase
Phase 1
Study Type
Interventional
Participants
Expecting 65 study participants
Last Updated