RecruitingPhase 1NCT05040204

The Effects of Dietary Supplementation on Serum Protein Glycosylation


Sponsor

University of California, Davis

Enrollment

44 participants

Start Date

Jun 23, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria1

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

Exclusion Criteria30

  • 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
  • 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

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Interventions

DIETARY_SUPPLEMENTMonosaccharide Powder

Monosaccharide powder dissolved in water.

DIETARY_SUPPLEMENTPlacebo Comparator

Placebo (glucose powder)


Locations(1)

University of California, Davis Medical Center

Sacramento, California, United States

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NCT05040204


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