Clinical trial NCT04386226: An Assessment of the Glyconutrient Ambrotose™ on Immunity, Gut Health, and Safety in Men and Women
Official title: An Assessment of the Glyconutrient Ambrotose™ on Immunity, Gut Health, and Safety in Men and Women: a Placebo-controlled, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Ambrotose
Immunity
Gut Health
Lead sponsor: University of Memphis
Sponsor class: OTHER
Collaborators: name: Mannatech, Inc
First posted: 2020-05-13
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-Blind, Randomized, Control
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the impact of two Ambrotose products on immunity, gut health, and associated measures in healthy men and women. Subjects are randomly assigned in double-blind manner to one of five conditions: 1) 2 grams Advanced Ambrotose, 2) 4 grams Advanced Ambrotose, 3) 2 grams Ambrotose LIFE, 4) 4 grams Ambrotose LIFE, or 5) placebo. Subjects ingested their assigned condition daily for eight weeks.

Detailed description: The product Ambrotose, which contains a blend of glyconutrients, has been used by human subjects for several years. It has been shown to enhance immunity, improve cognitive performance, and enhance antioxidant capacity. To date, the treatment with Ambrotose has been very well tolerated, with adverse events limited to "mild" or "self-limiting" or absent altogether.

This study evaluates the impact of two Ambrotose products on immunity, gut health, and associated measures in healthy men and women. Subjects are randomly assigned in double-blind manner to one of five conditions: 1) 2 grams Advanced Ambrotose, 2) 4 grams Ambrotose Advanced, 3) 2 grams Ambrotose LIFE, 4) 4 grams Ambrotose LIFE, or 5) placebo. Subjects ingested their assigned condition daily for eight weeks.

Eligibility criteria: Inclusion Criteria:

* must be physically active by participating in structured exercise at least twice per week for 30 or more minutes per session;
* not be pregnant

Exclusion Criteria:

* diagnosed cardiovascular disease
* diagnosed metabolic disease
* diagnosed neurological disease
* using nutritional supplements or medications known to impact immunity or gut health

Primary outcomes:
measure: general well-being (Short Form-12)
timeFrame: at baseline
measure: general well-being (Short Form-12)
timeFrame: at 4 weeks
measure: general well-being (Short Form-12)
timeFrame: at 8 weeks
measure: Self-reported psychological general well-being index
timeFrame: at baseline
measure: The Self-reported psychological general well-being index was used to assess subject's perceived well-being during their intervention. The index goes from 0 (worst possible level of well-being) to 110 (maximum level of well being)
timeFrame: at 4 weeks
measure: The Self-reported psychological general well-being index was used to assess subject's perceived well-being during their intervention. The index goes from 0 (worst possible level of well-being) to 110 (maximum level of well being)
timeFrame: at 8 weeks
measure: Self-reported assessment of fatigue & associated variables
timeFrame: at baseline
measure: Self-reported assessment of fatigue & associated variables
timeFrame: at 4 weeks
measure: Self-reported assessment of fatigue & associated variables
timeFrame: at 8 weeks
measure: White blood cell numbers
timeFrame: at baseline
measure: White blood cell numbers
timeFrame: at 4 weeks
measure: White blood cell numbers
timeFrame: at 8 weeks
measure: Interleukin-10 (IL-10) level following blood incubation
timeFrame: at baseline
measure: Interleukin-10 (IL-10) level following blood incubation
timeFrame: at 4 weeks
measure: Interleukin-10 (IL-10) level following blood incubation
timeFrame: at 8 weeks
measure: Interleukin-6 (IL-6) level following blood incubation
timeFrame: at baseline
measure: Interleukin-6 (IL-6) level following blood incubation
timeFrame: at 4 weeks
measure: Interleukin-6 (IL-6) level following blood incubation
timeFrame: at 8 weeks
measure: Interleukin-1beta (IL-1beta) level following blood incubation
timeFrame: at baseline
measure: Interleukin-1beta (IL-1beta) level following blood incubation
timeFrame: at 4 weeks
measure: Interleukin-1beta (IL-1beta) level following blood incubation
timeFrame: at 8 weeks
measure: Tumor Necrosis Factor alpha (TNFalpha) level following blood incubation
timeFrame: at baseline
measure: Tumor Necrosis Factor alpha (TNFalpha) level following blood incubation
timeFrame: at 4 weeks
measure: Tumor Necrosis Factor alpha (TNFalpha) level following blood incubation
timeFrame: at 8 weeks
measure: IL-10 level following blood incubation with lipopolysaccharide (LPS)
timeFrame: at baseline
measure: IL-10 level following blood incubation with lipopolysaccharide (LPS)
timeFrame: at 4 weeks
measure: IL-10 level following blood incubation with lipopolysaccharide (LPS)
timeFrame: at 8 weeks
measure: IL-6 level following blood incubation with LPS
timeFrame: at baseline
measure: IL-6 level following blood incubation with LPS
timeFrame: at 4 weeks
measure: IL-6 level following blood incubation with LPS
timeFrame: at 8 weeks
measure: IL-1beta level following blood incubation with LPS
timeFrame: at baseline
measure: IL-1beta level following blood incubation with LPS
timeFrame: at 4 weeks
measure: IL-1beta level following blood incubation with LPS
timeFrame: at 8 weeks
measure: TNFalpha level following blood incubation with LPS
timeFrame: at baseline
measure: TNFalpha level following blood incubation with LPS
timeFrame: at 4 weeks
measure: TNFalpha level following blood incubation with LPS
timeFrame: at 8 weeks
measure: Serum Zonulin levels
timeFrame: at baseline
measure: Serum Zonulin levels
timeFrame: at 4 weeks
measure: Serum Zonulin levels
timeFrame: at 8 weeks
Secondary outcomes:
measure: Dietary Intake
timeFrame: at baseline
measure: Dietary Intake
timeFrame: at 4 weeks
measure: Dietary Intake
timeFrame: at 8 weeks
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Center for Nutraceutical and Dietary Supplement Research
state: Tennessee
Study officials:
affiliation: University of Memphis
name: Richard Bloomer, PhD
role: PRINCIPAL_INVESTIGATOR
References: