An Assessment of the Glyconutrient Ambrotose™ on Immunity, Gut Health, and Safety in Men and Women

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Ambrotose LIFE; Dietary supplement: Advanced Ambrotose; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38152
      • Center for Nutraceutical and Dietary Supplement Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2 grams Ambrotose LIFE; 2 grams daily for 8 weeks	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.
Experimental: 4 grams Ambrotose LIFE; 4 grams daily for 8 weeks	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.
Active Comparator: 2 grams Advanced Ambrotose; 2 grams daily for 8 weeks	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
Active Comparator: 4 grams Advanced Ambrotose; 4 grams daily for 8 weeks	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
Placebo Comparator: Placebo; 4 grams Maltodextrin daily for 8 weeks	Other: Placebo; Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
general well-being (Short Form-12)	A 12-item questionnaire was used to measure functional health and well-being from the subject's point of view during their intervention. Scores range from 0 to 100, with higher scores representing better self-reported health	at baseline
general well-being (Short Form-12)	A 12-item questionnaire was used to measure functional health and well-being from the subject's point of view during their intervention. Scores range from 0 to 100, with higher scores representing better self-reported health	at 4 weeks
general well-being (Short Form-12)	A 12-item questionnaire was used to measure functional health and well-being from the subject's point of view during their intervention. Scores range from 0 to 100, with higher scores representing better self-reported health	at 8 weeks
Self-reported psychological general well-being index	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)	at baseline
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)	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)	at 4 weeks
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)	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)	at 8 weeks
Self-reported assessment of fatigue & associated variables	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 with 0 being "not at all" and 100 being "the most"	at baseline
Self-reported assessment of fatigue & associated variables	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 with 0 being "not at all" and 100 being "the most"	at 4 weeks
Self-reported assessment of fatigue & associated variables	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 with 0 being "not at all" and 100 being "the most"	at 8 weeks
White blood cell numbers	We determined the white blood cell numbers for each subject during their intervention.	at baseline
White blood cell numbers	We determined the white blood cell numbers for each subject during their intervention.	at 4 weeks
White blood cell numbers	We determined the white blood cell numbers for each subject during their intervention.	at 8 weeks
Interleukin-10 (IL-10) level following blood incubation	IL-10 was measured following blood incubation with Roswell Park Memorial Institute (RPMI) medium for 6 hrs	at baseline
Interleukin-10 (IL-10) level following blood incubation	IL-10 was measured following blood incubation with Roswell Park Memorial Institute (RPMI) medium for 6 hrs	at 4 weeks
Interleukin-10 (IL-10) level following blood incubation	IL-10 was measured following blood incubation with Roswell Park Memorial Institute (RPMI) medium for 6 hrs	at 8 weeks
Interleukin-6 (IL-6) level following blood incubation	IL-6 was measured following blood incubation with RPMI medium for 6 hrs	at baseline
Interleukin-6 (IL-6) level following blood incubation	IL-6 was measured following blood incubation with RPMI medium for 6 hrs	at 4 weeks
Interleukin-6 (IL-6) level following blood incubation	IL-6 was measured following blood incubation with RPMI medium for 6 hrs	at 8 weeks
Interleukin-1beta (IL-1beta) level following blood incubation	IL-1beta was measured following blood incubation with RPMI medium for 6 hrs	at baseline
Interleukin-1beta (IL-1beta) level following blood incubation	IL-1beta was measured following blood incubation with RPMI medium for 6 hrs	at 4 weeks
Interleukin-1beta (IL-1beta) level following blood incubation	IL-1beta was measured following blood incubation with RPMI medium for 6 hrs	at 8 weeks
Tumor Necrosis Factor alpha (TNFalpha) level following blood incubation	TNFalpha was measured following blood incubation with RPMI medium for 6 hrs	at baseline
Tumor Necrosis Factor alpha (TNFalpha) level following blood incubation	TNFalpha was measured following blood incubation with RPMI medium for 6 hrs	at 4 weeks
Tumor Necrosis Factor alpha (TNFalpha) level following blood incubation	TNFalpha was measured following blood incubation with RPMI medium for 6 hrs	at 8 weeks
IL-10 level following blood incubation with lipopolysaccharide (LPS)	IL-10 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs	at baseline
IL-10 level following blood incubation with lipopolysaccharide (LPS)	IL-10 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs	at 4 weeks
IL-10 level following blood incubation with lipopolysaccharide (LPS)	IL-10 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs	at 8 weeks
IL-6 level following blood incubation with LPS	IL-6 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs	at baseline
IL-6 level following blood incubation with LPS	IL-6 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs	at 4 weeks
IL-6 level following blood incubation with LPS	IL-6 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs	at 8 weeks
IL-1beta level following blood incubation with LPS	IL-1beta was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs	at baseline
IL-1beta level following blood incubation with LPS	IL-1beta was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs	at 4 weeks
IL-1beta level following blood incubation with LPS	IL-1beta was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs	at 8 weeks
TNFalpha level following blood incubation with LPS	TNFalpha was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs	at baseline
TNFalpha level following blood incubation with LPS	TNFalpha was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs	at 4 weeks
TNFalpha level following blood incubation with LPS	TNFalpha was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs	at 8 weeks
Serum Zonulin levels	Zonulin from blood serum during the intervention was measured using an ELISA	at baseline
Serum Zonulin levels	Zonulin from blood serum during the intervention was measured using an ELISA	at 4 weeks
Serum Zonulin levels	Zonulin from blood serum during the intervention was measured using an ELISA	at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary Intake	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	at baseline
Dietary Intake	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	at 4 weeks
Dietary Intake	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	at 8 weeks

Collaborators and Investigators

• Sponsor: University of Memphis
• Collaborators: Mannatech, Inc

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Immunity; Ambrotose; Gut Health
• Other Study ID Numbers: PRO-FY2018-488

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No