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| Name | Class |
|---|---|
| Mannatech, Inc | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 grams Ambrotose LIFE | Experimental | 2 grams daily for 8 weeks |
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| 4 grams Ambrotose LIFE | Experimental | 4 grams daily for 8 weeks |
|
| 2 grams Advanced Ambrotose | Active Comparator | 2 grams daily for 8 weeks |
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| 4 grams Advanced Ambrotose | Active Comparator | 4 grams daily for 8 weeks |
|
| Placebo | Placebo Comparator | 4 grams Maltodextrin daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambrotose LIFE | Dietary Supplement | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Bloomer, PhD | University of Memphis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Nutraceutical and Dietary Supplement Research | Memphis | Tennessee | 38152 | United States |
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Double-Blind, Randomized, Control
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Double-Blind
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| Advanced Ambrotose | Dietary Supplement | 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 | Other | Maltodextrin |
|
| 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 |
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 |