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Completed

NCT Number: NCT04386226

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

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.

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Key information

Conditions

Healthy

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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)

  6. 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)

  7. 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"

  8. 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"

  9. 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"

  10. White blood cell numbers

    Time frame: at baseline

    We determined the white blood cell numbers for each subject during their intervention.

  11. White blood cell numbers

    Time frame: at 4 weeks

    We determined the white blood cell numbers for each subject during their intervention.

  12. White blood cell numbers

    Time frame: at 8 weeks

    We determined the white blood cell numbers for each subject during their intervention.

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. Serum Zonulin levels

    Time frame: at baseline

    Zonulin from blood serum during the intervention was measured using an ELISA

  38. Serum Zonulin levels

    Time frame: at 4 weeks

    Zonulin from blood serum during the intervention was measured using an ELISA

  39. Serum Zonulin levels

    Time frame: at 8 weeks

    Zonulin from blood serum during the intervention was measured using an ELISA

Secondary outcomes

  1. Dietary Intake

    Time frame: at baseline

    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

  2. Dietary Intake

    Time frame: at 4 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

  3. Dietary Intake

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Memphis

Other

Collaborators

  • Mannatech, Inc

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 13, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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