An Assessment of the Glyconutrient Ambrotose™ on Immunity, Gut Health, and Safety in Men and Women: a Placebo-controlled, Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Memphis
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- general well-being (Short Form-12)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Masking Description
Double-Blind
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
2 grams Ambrotose LIFE
2 grams daily for 8 weeks
Intervention: Ambrotose LIFE (Dietary Supplement)
4 grams Ambrotose LIFE
4 grams daily for 8 weeks
Intervention: Ambrotose LIFE (Dietary Supplement)
2 grams Advanced Ambrotose
2 grams daily for 8 weeks
Intervention: Advanced Ambrotose (Dietary Supplement)
4 grams Advanced Ambrotose
4 grams daily for 8 weeks
Intervention: Advanced Ambrotose (Dietary Supplement)
Placebo
4 grams Maltodextrin daily for 8 weeks
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
general well-being (Short Form-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. Scores range from 0 to 100, with higher scores representing better self-reported health
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)
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. The index goes from 0 (worst possible level of well-being) to 110 (maximum level of well being)
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-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
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. The index goes from 0 (worst possible level of well-being) to 110 (maximum level of well being)
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 with 0 being "not at all" and 100 being "the most"
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
White blood cell numbers
Time Frame: at 8 weeks
We determined the white blood cell numbers for each subject during their intervention.
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
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 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 8 weeks
Zonulin from blood serum during the intervention was measured using an ELISA
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 8 weeks
IL-10 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
general well-being (Short Form-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. Scores range from 0 to 100, with higher scores representing better self-reported health
general well-being (Short Form-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. Scores range from 0 to 100, with higher scores representing better self-reported health
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)
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. The index goes from 0 (worst possible level of well-being) to 110 (maximum level of well being)
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 with 0 being "not at all" and 100 being "the most"
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 with 0 being "not at all" and 100 being "the most"
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.
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-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-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
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
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-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-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
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
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
Secondary Outcomes
- Dietary Intake(at 8 weeks)
- Dietary Intake(at baseline)
- Dietary Intake(at 4 weeks)
Investigators
Richard Bloomer
Dean
University of Memphis