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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Ambrotose LIFE
* Dietary Supplement: Advanced Ambrotose
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-Blind, Randomized, Control
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 grams Ambrotose LIFE<br>2 grams daily for 8 weeks | Dietary Supplement: Ambrotose LIFE<br>* 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.<br>|
| Experimental: 4 grams Ambrotose LIFE<br>4 grams daily for 8 weeks | Dietary Supplement: Ambrotose LIFE<br>* 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.<br>|
| Active Comparator: 2 grams Advanced Ambrotose<br>2 grams daily for 8 weeks | Dietary Supplement: Advanced Ambrotose<br>* 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<br>|
| Active Comparator: 4 grams Advanced Ambrotose<br>4 grams daily for 8 weeks | Dietary Supplement: Advanced Ambrotose<br>* 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<br>|
| Placebo Comparator: Placebo<br>4 grams Maltodextrin daily for 8 weeks | Other: Placebo<br>* Maltodextrin<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ambrotose, Immunity, Gut Health