Clinical trial NCT04466761: Ascending Glycan Dietary Supplementation in Healthy Adults
Official title: Phase I Ascending Dose Study of Dietary Supplementation With Glycan Monomers in Healthy Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Individuals
Keywords: Healthy Adults
Dietary supplements
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 14
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: 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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Characterize Immunoglobulin fragment crystallization modifications
timeFrame: 4 Weeks
measure: Identify the maximum effective dose
timeFrame: 16 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: