An Assessment of the Glyconutrient Ambrotose™ on Immunity, Gut Health, and Safety in Men and Women
- Conditions
- Healthy
- Interventions
- Dietary Supplement: Ambrotose LIFEDietary Supplement: Advanced AmbrotoseOther: Placebo
- Registration Number
- NCT04386226
- Lead Sponsor
- University of Memphis
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- must be physically active by participating in structured exercise at least twice per week for 30 or more minutes per session;
- not be pregnant
- diagnosed cardiovascular disease
- diagnosed metabolic disease
- diagnosed neurological disease
- using nutritional supplements or medications known to impact immunity or gut health
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 grams Ambrotose LIFE Ambrotose LIFE 4 grams daily for 8 weeks 2 grams Ambrotose LIFE Ambrotose LIFE 2 grams daily for 8 weeks 4 grams Advanced Ambrotose Advanced Ambrotose 4 grams daily for 8 weeks 2 grams Advanced Ambrotose Advanced Ambrotose 2 grams daily for 8 weeks Placebo Placebo 4 grams Maltodextrin daily for 8 weeks
- Primary Outcome Measures
Name Time Method 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 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)
Interleukin-10 (IL-10) level following blood incubation at 8 weeks IL-10 was measured following blood incubation with Roswell Park Memorial Institute (RPMI) medium for 6 hrs
Interleukin-1beta (IL-1beta) level following blood incubation at 8 weeks IL-1beta was measured following blood incubation with RPMI medium for 6 hrs
general well-being (Short Form-12) 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
Self-reported psychological general well-being index 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)
Self-reported assessment of fatigue & associated variables 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"
IL-6 level following blood incubation with LPS at 8 weeks IL-6 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
White blood cell numbers at 8 weeks We determined the white blood cell numbers for each subject during their intervention.
Interleukin-6 (IL-6) level following blood incubation at 8 weeks IL-6 was measured following blood incubation with RPMI medium for 6 hrs
IL-1beta level following blood incubation with LPS at 8 weeks IL-1beta was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
TNFalpha level following blood incubation with LPS at 8 weeks TNFalpha was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
Serum Zonulin levels at 8 weeks Zonulin from blood serum during the intervention was measured using an ELISA
Tumor Necrosis Factor alpha (TNFalpha) level following blood incubation at 8 weeks TNFalpha was measured following blood incubation with RPMI medium for 6 hrs
IL-10 level following blood incubation with lipopolysaccharide (LPS) at 8 weeks IL-10 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
- Secondary Outcome Measures
Name Time Method Dietary Intake 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
Trial Locations
- Locations (1)
Center for Nutraceutical and Dietary Supplement Research
🇺🇸Memphis, Tennessee, United States