Ascending Glycan Dietary Supplementation in Healthy Adults

University of California (UC) Davis

Status and phase: Enrolling; Phase 1

Conditions: Healthy Individuals

Treatments: Other: Placebo Comparator; Dietary Supplement: Monosaccharide Powder

Study type: Interventional

Funder types: Other

Identifiers

NCT04466761

1516913

Details and patient eligibility

About

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).

Enrollment: 65 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 2 patient groups, including a placebo group

Experimental: Cohort 1-4

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Monosaccharide Powder

Placebo: Cohort 1-4

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo Comparator