Recruiting
Phase 1

Dietary Supplementation

Sponsor:

UCLA

Code:

NCT05040204

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Monosaccharide Powder

Placebo Comparator

Study Details

Brief 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.

Conditions

Healthy

Study ID

NCT05040204

Start date

Jun 23, 2022

Status verified date

May, 2026

Completion date

Nov 22, 2026

Anticipated

Primary completion date

Nov 22, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Experimental Supplement 1

6 subjects will consume 12 grams of dietary supplement 1 daily for 4 weeks

experimental: Experimental Supplement 2

6 subjects will consume 12 grams of dietary supplement 2 daily for 4 weeks

experimental: Experimental Supplement 3

20 subjects will consume 50 grams of dietary supplement 3 daily for 4 weeks

placebo comparator: Placebo Comparator 1

6 subjects will consume 12 grams of placebo dietary supplement daily for 4 weeks

placebo comparator: Placebo Comparator 2

6 subjects will consume 50 grams of placebo dietary supplement daily for 4 weeks

Interventions

Monosaccharide Powder

Monosaccharide powder dissolved in water.

Placebo Comparator

Placebo (glucose powder)

Primary outcome measure

  • Characterize Immunoglobulin fragment crystallization modifications [ Time Frame: 4 Weeks ]

Central Contacts and Locations

Central contacts

Emanual Maverakis, MD

916-551-2635emaverakis@ucdavis.edu

Locations

University of California, Davis Medical Center

Recruiting

Sacramento, California, United States, 95816

Contacts

Monica Tran, BS

916-551-2634montran@ucdavis.edu

Principal Investigator:

Emanual Maverakis, MD

More Information

Sponsor

University of California, Davis

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

  • dietary supplement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-05-28.