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

NCT ID: NCT04386226

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2019-06-01

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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-Blind, Randomized, Control
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Double-Blind

Study Groups

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2 grams Ambrotose LIFE

2 grams daily for 8 weeks

Group Type EXPERIMENTAL

Ambrotose LIFE

Intervention Type 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.

4 grams Ambrotose LIFE

4 grams daily for 8 weeks

Group Type EXPERIMENTAL

Ambrotose LIFE

Intervention Type 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.

2 grams Advanced Ambrotose

2 grams daily for 8 weeks

Group Type ACTIVE_COMPARATOR

Advanced Ambrotose

Intervention Type 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

4 grams Advanced Ambrotose

4 grams daily for 8 weeks

Group Type ACTIVE_COMPARATOR

Advanced Ambrotose

Intervention Type 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

4 grams Maltodextrin daily for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Maltodextrin

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Maltodextrin

Intervention Type OTHER

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mannatech, Inc

UNKNOWN

Sponsor Role collaborator

University of Memphis

OTHER

Sponsor Role lead

Responsible Party

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Richard Bloomer

Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Bloomer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Memphis

Locations

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Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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PRO-FY2018-488

Identifier Type: -

Identifier Source: org_study_id

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