An Assessment of the Glyconutrient Ambrotose™ on Immunity, Gut Health, and Safety in Men and Women: a Placebo-controlled

Overview

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.

Full Title of Study: “An Assessment of the Glyconutrient Ambrotose™ on Immunity, Gut Health, and Safety in Men and Women: a Placebo-controlled, Randomized Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 15, 2019

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.

Interventions

  • Dietary Supplement: Ambrotose LIFE
    • Ambrotose LIFE contains aloe vera extract inner leaf gel, arabinogalactin, ghatti gum, glucosamine hydrogen chloride, gum tragacanth, vitamin A, beta carotene, wakame algae extract, rice starch, RiFiber (rice bran), and Modified Citrus Pectin with Sodium Alginate.
  • Dietary Supplement: Advanced Ambrotose
    • Advanced Ambrotose contains aloe vera extract inner leaf gel, arabinogalactan, ghatti gum, glucosamine hydrogen chloride, gum tragacanth, vitamin A, beta carotene, wakame algae extract, and rice starch
  • Other: Placebo
    • Maltodextrin

Arms, Groups and Cohorts

  • Experimental: 2 grams Ambrotose LIFE
    • 2 grams daily for 8 weeks
  • Experimental: 4 grams Ambrotose LIFE
    • 4 grams daily for 8 weeks
  • Active Comparator: 2 grams Advanced Ambrotose
    • 2 grams daily for 8 weeks
  • Active Comparator: 4 grams Advanced Ambrotose
    • 4 grams daily for 8 weeks
  • Placebo Comparator: Placebo
    • 4 grams Maltodextrin daily for 8 weeks

Clinical Trial Outcome Measures

Primary Measures

  • general well-being (SF-12)
    • Time Frame: at baseline
    • A 12-item questionnaire was used to measure functional health and well-being from the subject’s point of view during their intervention.
  • general well-being (SF-12)
    • Time Frame: at 4 weeks
    • A 12-item questionnaire was used to measure functional health and well-being from the subject’s point of view during their intervention.
  • general well-being (SF-12)
    • Time Frame: at 8 weeks
    • A 12-item questionnaire was used to measure functional health and well-being from the subject’s point of view during their intervention.
  • Self-reported psychological general well-being index
    • Time Frame: at baseline
    • The Self-reported psychological general well-being index was used to assess subject’s perceived well-being during their intervention
  • Self-reported psychological general well-being index
    • Time Frame: at 4 weeks
    • The Self-reported psychological general well-being index was used to assess subject’s perceived well-being during their intervention
  • Self-reported psychological general well-being index
    • Time Frame: at 8 weeks
    • The Self-reported psychological general well-being index was used to assess subject’s perceived well-being during their intervention
  • Self-reported assessment of fatigue & associated variables
    • Time Frame: at baseline
    • A visual analog scale in which the subject was asked to make a mark on a 100-mm scale to indicate how he/she felt in regards to the variable in question during their intervention
  • Self-reported assessment of fatigue & associated variables
    • Time Frame: at 4 weeks
    • A visual analog scale in which the subject was asked to make a mark on a 100-mm scale to indicate how he/she felt in regards to the variable in question during their intervention
  • Self-reported assessment of fatigue & associated variables
    • Time Frame: at 8 weeks
    • A visual analog scale in which the subject was asked to make a mark on a 100-mm scale to indicate how he/she felt in regards to the variable in question during their intervention
  • White blood cell numbers
    • Time Frame: at baseline
    • We determined the white blood cell numbers for each subject during their intervention.
  • White blood cell numbers
    • Time Frame: at 4 weeks
    • We determined the white blood cell numbers for each subject during their intervention.
  • White blood cell numbers
    • Time Frame: at 8 weeks
    • We determined the white blood cell numbers for each subject during their intervention.
  • Interleukin-10 (IL-10) level following blood incubation
    • Time Frame: at baseline
    • IL-10 was measured following blood incubation with Roswell Park Memorial Institute (RPMI) medium for 6 hrs
  • Interleukin-10 (IL-10) level following blood incubation
    • Time Frame: at 4 weeks
    • IL-10 was measured following blood incubation with Roswell Park Memorial Institute (RPMI) medium for 6 hrs
  • Interleukin-10 (IL-10) level following blood incubation
    • Time Frame: at 8 weeks
    • IL-10 was measured following blood incubation with Roswell Park Memorial Institute (RPMI) medium for 6 hrs
  • Interleukin-6 (IL-6) level following blood incubation
    • Time Frame: at baseline
    • IL-6 was measured following blood incubation with RPMI medium for 6 hrs
  • Interleukin-6 (IL-6) level following blood incubation
    • Time Frame: at 4 weeks
    • IL-6 was measured following blood incubation with RPMI medium for 6 hrs
  • Interleukin-6 (IL-6) level following blood incubation
    • Time Frame: at 8 weeks
    • IL-6 was measured following blood incubation with RPMI medium for 6 hrs
  • Interleukin-1beta (IL-1beta) level following blood incubation
    • Time Frame: at baseline
    • IL-1beta was measured following blood incubation with RPMI medium for 6 hrs
  • Interleukin-1beta (IL-1beta) level following blood incubation
    • Time Frame: at 4 weeks
    • IL-1beta was measured following blood incubation with RPMI medium for 6 hrs
  • Interleukin-1beta (IL-1beta) level following blood incubation
    • Time Frame: at 8 weeks
    • IL-1beta was measured following blood incubation with RPMI medium for 6 hrs
  • Tumor Necrosis Factor alpha (TNFalpha) level following blood incubation
    • Time Frame: at baseline
    • TNFalpha was measured following blood incubation with RPMI medium for 6 hrs
  • Tumor Necrosis Factor alpha (TNFalpha) level following blood incubation
    • Time Frame: at 4 weeks
    • TNFalpha was measured following blood incubation with RPMI medium for 6 hrs
  • Tumor Necrosis Factor alpha (TNFalpha) level following blood incubation
    • Time Frame: at 8 weeks
    • TNFalpha was measured following blood incubation with RPMI medium for 6 hrs
  • IL-10 level following blood incubation with lipopolysaccharide (LPS)
    • Time Frame: at baseline
    • IL-10 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
  • IL-10 level following blood incubation with lipopolysaccharide (LPS)
    • Time Frame: at 4 weeks
    • IL-10 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
  • IL-10 level following blood incubation with lipopolysaccharide (LPS)
    • Time Frame: at 8 weeks
    • IL-10 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
  • IL-6 level following blood incubation with LPS
    • Time Frame: at baseline
    • IL-6 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
  • IL-6 level following blood incubation with LPS
    • Time Frame: at 4 weeks
    • IL-6 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
  • IL-6 level following blood incubation with LPS
    • Time Frame: at 8 weeks
    • IL-6 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
  • IL-1beta level following blood incubation with LPS
    • Time Frame: at baseline
    • IL-1beta was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
  • IL-1beta level following blood incubation with LPS
    • Time Frame: at 4 weeks
    • IL-1beta was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
  • IL-1beta level following blood incubation with LPS
    • Time Frame: at 8 weeks
    • IL-1beta was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
  • TNFalpha level following blood incubation with LPS
    • Time Frame: at baseline
    • TNFalpha was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
  • TNFalpha level following blood incubation with LPS
    • Time Frame: at 4 weeks
    • TNFalpha was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
  • TNFalpha level following blood incubation with LPS
    • Time Frame: at 8 weeks
    • TNFalpha was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
  • Serum Zonulin levels
    • Time Frame: at baseline
    • Zonulin from blood serum during the intervention was measured using an ELISA
  • Serum Zonulin levels
    • Time Frame: at 4 weeks
    • Zonulin from blood serum during the intervention was measured using an ELISA
  • Serum Zonulin levels
    • Time Frame: at 8 weeks
    • Zonulin from blood serum during the intervention was measured using an ELISA

Secondary Measures

  • Dietary Intake
    • Time Frame: at baseline
    • Dietary intake of subjects for 5-days prior to testing days was entered into Food Processor Pro software and analyzed for analyzed for total calories, macro- and micro-nutrient composition
  • Dietary Intake
    • Time Frame: at 4 weeks
    • Dietary intake of subjects for 5-days prior to testing days was entered into Food Processor Pro software and analyzed for analyzed for total calories, macro- and micro-nutrient composition
  • Dietary Intake
    • Time Frame: at 8 weeks
    • Dietary intake of subjects for 5-days prior to testing days was entered into Food Processor Pro software and analyzed for analyzed for total calories, macro- and micro-nutrient composition

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Memphis
  • Collaborator
    • Mannatech, Inc
  • Provider of Information About this Clinical Study
    • Principal Investigator: Richard Bloomer, Dean of School of Health Studies – University of Memphis
  • Overall Official(s)
    • Richard Bloomer, PhD, Principal Investigator, University of Memphis

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