Ascending Glycan Dietary Supplementation in Healthy Adults

NCT ID: NCT04466761

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-23
• Study Completion Date: 2024-08-06

Brief 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).

Conditions

Healthy Individuals

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Experimental: Cohort 1-4

60% of subjects per cohort will consume 30-90 grams of dietary supplement daily for 4 weeks, with each successive cohort dosage increasing according to a Fibonacci dose escalation.

Group Type: EXPERIMENTAL

Monosaccharide Powder

Intervention Type: DIETARY_SUPPLEMENT

Monosaccharide powder dissolved in water.

Placebo: Cohort 1-4

40% of subjects per cohort will consume 30-90 grams of daily placebo for 4 weeks with each successive cohort dosage increasing in parallel to the experimental arm.

Group Type: PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type: OTHER

Placebo (cellulose powder).

Interventions

Monosaccharide Powder

Monosaccharide powder dissolved in water.

Intervention Type: DIETARY_SUPPLEMENT

Placebo Comparator

Placebo (cellulose powder).

Intervention Type: OTHER

Eligibility Criteria

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

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emanual Maverakis, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California, Davis Medical Center

Sacramento, California, United States

Countries

United States

Other Identifiers

1516913

Identifier Type: -

Identifier Source: org_study_id