Ascending Glycan Dietary Supplementation in Healthy Adults

Healthy Individuals Clinical Trial

Official title:

Phase I Ascending Dose Study of Dietary Supplementation With Glycan Monomers in Healthy Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04466761
• Other study ID #: 1516913
• Status: Recruiting
• Phase: Phase 1
• Start date: June 23, 2022
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: University of California, Davis
• Contact: Emanual Maverakis, MD
• Phone: 916-551-2635
• Email: emaverakis[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Individuals

Intervention

Dietary Supplement:
• Monosaccharide Powder
Monosaccharide powder dissolved in water.

Other:
• Placebo Comparator
Placebo (cellulose powder).

Locations

Country	Name	City	State
United States	University of California, Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize Immunoglobulin fragment crystallization modifications	Use mass spectrometry and RNA sequencing from subject blood samples to characterize site specific glycosylation on Immunoglobulin A, Immunoglobulin M, and Immunoglobulin G.	4 Weeks
Primary	Identify the maximum effective dose	Identify maximum effective dose of dietary supplement in grams/day.	16 Weeks
Secondary	Assess for potential adverse events	Monitor symptoms, severity, and duration of adverse events.	2 Months after first dose
Secondary	Quantification of enzymatic modifications measured in grams by spectrometry	The investigators will measure enzymatic changes on glycoproteins in the immune system by spectrometry, i.e., these changes will be measured in grams. Spectometry will allow the investigators to quantify these changes in small detail, and therefore give a better idea of how supplementation can change enzymatic process that then affect the structure, and mass, of glycoproteins.	6 Months
Secondary	Flow cytometry to determine the effect of dietary supplementation on the immune system	Perform flow cytometry on subject blood samples to determine the effect of dietary supplement on immune system. For example, the investigators will note changes to immune cell pro-inflammatory and anti-inflammatory cytokine clusters as translated proteins (measured as height and area of cytokine intensity).	6 Months
Secondary	Transcriptome analysis to determine the effect of dietary supplementation on the immune system	Perform transcriptome analysis on subject blood samples to determine the effect of dietary supplement on immune system. For example, the investigators will note changes to immune cell pro-inflammatory and anti-inflammatory cytokine clusters as RNA (measure on a logarithmic scale per number of reads) to determine the effects of supplementation on both gene transcription and translation.	6 Months