RECRUITING

The Effects of Dietary Supplementation on Serum Protein Glycosylation

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Healthydietary supplement

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effects of Dietary Supplementation on Serum Protein Glycosylation

Quick Facts

Study Start:2022-06-23
Study Completion:2025-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05040204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult men/women (age 18-45) who are in general good health with Body Mass Index (BMI) range of 18.5-25
  1. * Adults younger than 18 or older than 45 years of age
  2. * Women who are pregnant, actively nursing or have had a pregnancy within the last year
  3. * Women who are peri-menopausal or post-menopausal
  4. * 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)
  5. * Women on hormonal contraception, including birth control, hormonal intrauterine device, or contraceptive implant
  6. * Individuals with past medical history of an autoimmune condition or malignancy, excluding non-melanoma skin cancer
  7. * Individuals with cardiovascular, pulmonary, reproductive, endocrine, metabolic, neurologic, gastrointestinal, hematologic, or infectious diseases of any type
  8. * Individuals with diagnosis of galactosemia or congenital disorders of glycosylation
  9. * Individuals with phenylketonuria
  10. * Individuals currently taking prescription medications, or who have taken prescription medications within the last 3 months
  11. * Individuals currently taking over-the-counter medications
  12. * 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
  13. * Individuals with BMI less than 18.5 or greater than 25
  14. * Individuals with prior history of severe food or drug allergic reactions
  15. * Individuals with allergic reaction or adverse reaction to shellfish, N-acetylglucosamine, galactose, Spirulina/chlorella/algae supplements, or arabinose containing compounds/foods/supplements
  16. * Individuals with first-degree relative with history of an autoimmune condition
  17. * Individuals with social history of current use of tobacco, alcohol or other drugs
  18. * 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):
  19. * Actively dieting or trying to lose weight
  20. * Vegan diet
  21. * Consume equal to or greater than 2 cups of tea a day
  22. * Consume equal to or greater than 4 cups of coffee a day
  23. * Consume equal to or greater than 3 cups of fruit juice a day
  24. * Practice intensive exercise patterns (marathon training, workouts \>4 hours a day)
  25. * Consume soda or energy drinks of any amount
  26. * Consume fast food equal to or greater than 5 days per week
  27. * Consume greater than one serving of alcohol per day
  28. * (1 serving of wine = 6 oz, 1 serving of beer = 12 oz, 1 serving of spirits = 1 oz)
  29. * On a carbohydrate-restricted or "Paleo" diet, or calorie-restricted diet (less than 20-25% of maintenance calories)
  30. * Adults unable to consent
  31. * Prisoners

Contacts and Locations

Study Contact

Emanual Maverakis, MD
CONTACT
916-551-2635
emaverakis@ucdavis.edu

Principal Investigator

Emanual Maverakis, MD
PRINCIPAL_INVESTIGATOR
University of California, Davis

Study Locations (Sites)

University of California, Davis Medical Center
Sacramento, California, 95816
United States

Collaborators and Investigators

Sponsor: University of California, Davis

  • Emanual Maverakis, MD, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-23
Study Completion Date2025-09-01

Study Record Updates

Study Start Date2022-06-23
Study Completion Date2025-09-01

Terms related to this study

Keywords Provided by Researchers

  • dietary supplement

Additional Relevant MeSH Terms

  • Healthy