An Assessment of the Glyconutrient Ambrotose™ on Immunity, Gut Health, and Safety in Men and Women
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Aug 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 5, 2020
CompletedFirst Posted
Study publicly available on registry
May 13, 2020
CompletedApril 28, 2021
April 1, 2021
7 months
May 5, 2020
April 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (39)
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 Outcomes (3)
Dietary Intake
at baseline
Dietary Intake
at 4 weeks
Dietary Intake
at 8 weeks
Study Arms (5)
2 grams Ambrotose LIFE
EXPERIMENTAL2 grams daily for 8 weeks
4 grams Ambrotose LIFE
EXPERIMENTAL4 grams daily for 8 weeks
2 grams Advanced Ambrotose
ACTIVE COMPARATOR2 grams daily for 8 weeks
4 grams Advanced Ambrotose
ACTIVE COMPARATOR4 grams daily for 8 weeks
Placebo
PLACEBO COMPARATOR4 grams Maltodextrin daily for 8 weeks
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- must be physically active by participating in structured exercise at least twice per week for 30 or more minutes per session;
- not be pregnant
You may not qualify if:
- diagnosed cardiovascular disease
- diagnosed metabolic disease
- diagnosed neurological disease
- using nutritional supplements or medications known to impact immunity or gut health
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Memphislead
- Mannatech, Inccollaborator
Study Sites (1)
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, 38152, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Bloomer, PhD
University of Memphis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-Blind
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dean
Study Record Dates
First Submitted
May 5, 2020
First Posted
May 13, 2020
Study Start
August 15, 2018
Primary Completion
March 15, 2019
Study Completion
June 1, 2019
Last Updated
April 28, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share