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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04386226
• Other study ID #: PRO-FY2018-488
• Status: Completed
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: April 2021
• Source: University of Memphis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 1, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Ambrotose LIFE
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
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

Other:
• Placebo
Maltodextrin

Locations

Country	Name	City	State
United States	Center for Nutraceutical and Dietary Supplement Research	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Memphis	Mannatech, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	White blood cell numbers	We determined the white blood cell numbers for each subject during their intervention.	at baseline
Primary	White blood cell numbers	We determined the white blood cell numbers for each subject during their intervention.	at 4 weeks
Primary	White blood cell numbers	We determined the white blood cell numbers for each subject during their intervention.	at 8 weeks
Primary	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
Primary	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
Primary	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
Primary	Interleukin-6 (IL-6) level following blood incubation	IL-6 was measured following blood incubation with RPMI medium for 6 hrs	at baseline
Primary	Interleukin-6 (IL-6) level following blood incubation	IL-6 was measured following blood incubation with RPMI medium for 6 hrs	at 4 weeks
Primary	Interleukin-6 (IL-6) level following blood incubation	IL-6 was measured following blood incubation with RPMI medium for 6 hrs	at 8 weeks
Primary	Interleukin-1beta (IL-1beta) level following blood incubation	IL-1beta was measured following blood incubation with RPMI medium for 6 hrs	at baseline
Primary	Interleukin-1beta (IL-1beta) level following blood incubation	IL-1beta was measured following blood incubation with RPMI medium for 6 hrs	at 4 weeks
Primary	Interleukin-1beta (IL-1beta) level following blood incubation	IL-1beta was measured following blood incubation with RPMI medium for 6 hrs	at 8 weeks
Primary	Tumor Necrosis Factor alpha (TNFalpha) level following blood incubation	TNFalpha was measured following blood incubation with RPMI medium for 6 hrs	at baseline
Primary	Tumor Necrosis Factor alpha (TNFalpha) level following blood incubation	TNFalpha was measured following blood incubation with RPMI medium for 6 hrs	at 4 weeks
Primary	Tumor Necrosis Factor alpha (TNFalpha) level following blood incubation	TNFalpha was measured following blood incubation with RPMI medium for 6 hrs	at 8 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Serum Zonulin levels	Zonulin from blood serum during the intervention was measured using an ELISA	at baseline
Primary	Serum Zonulin levels	Zonulin from blood serum during the intervention was measured using an ELISA	at 4 weeks
Primary	Serum Zonulin levels	Zonulin from blood serum during the intervention was measured using an ELISA	at 8 weeks
Secondary	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
Secondary	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
Secondary	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