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Recruiting NCT05040204

The Effects of Dietary Supplementation on Serum Protein Glycosylation

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Monosaccharide Powder, Placebo Comparator.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Dietary supplement Monosaccharide Powder
    Monosaccharide powder dissolved in water.
  • Dietary supplement Placebo Comparator
    Placebo (glucose powder)

Primary outcome measures

  • Characterize Immunoglobulin fragment crystallization modifications [Time frame: 4 Weeks]
Secondary outcome measures (4)
  • Assess for potential adverse events [Time frame: 2 months after first dose]
  • Quantification of enzymatic modifications measured in grams by spectrometry [Time frame: 6 months]
  • Flow cytometry to determine the effect of dietary supplementation on the immune system [Time frame: 6 months]
  • Transcriptome analysis to determine the effect of dietary supplementation on the immune system [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of California, Davis Medical Center — Sacramento

Identifiers

NCT: NCT05040204 · 949221 · 1K24AR077313-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗