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

University of Memphis logo

University of Memphis

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Advanced Ambrotose
Other: Placebo
Dietary Supplement: Ambrotose LIFE

Study type

Interventional

Funder types

Other

Identifiers

NCT04386226
PRO-FY2018-488

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

75 participants in 5 patient groups, including a placebo group

2 grams Ambrotose LIFE
Experimental group
Description:
2 grams daily for 8 weeks
Treatment:
Dietary Supplement: Ambrotose LIFE
4 grams Ambrotose LIFE
Experimental group
Description:
4 grams daily for 8 weeks
Treatment:
Dietary Supplement: Ambrotose LIFE
2 grams Advanced Ambrotose
Active Comparator group
Description:
2 grams daily for 8 weeks
Treatment:
Dietary Supplement: Advanced Ambrotose
4 grams Advanced Ambrotose
Active Comparator group
Description:
4 grams daily for 8 weeks
Treatment:
Dietary Supplement: Advanced Ambrotose
Placebo
Placebo Comparator group
Description:
4 grams Maltodextrin daily for 8 weeks
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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