HealthyNCT04386226
An Assessment of the Glyconutrient Ambrotose™ on Immunity, Gut Health, and Safety in Men and Women
A study testing Ambrotose LIFE and Advanced Ambrotose in people with Healthy, run by University of Memphis at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ambrotose LIFE and Advanced Ambrotose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- must be physically active by participating in structured exercise at least twice per week for 30 or more minutes per session;
- not be pregnant
Who cannot join
- diagnosed cardiovascular disease
- diagnosed metabolic disease
- diagnosed neurological disease
- using nutritional supplements or medications known to impact immunity or gut health
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, 38152
About this study
Official title: An Assessment of the Glyconutrient Ambrotose™ on Immunity, Gut Health, and Safety in Men and Women: a Placebo-controlled, Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Ambrotose LIFE, Advanced Ambrotose, Placebo
- Keywords
- Ambrotose, Immunity, Gut Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambrotose LIFEDietary 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 AmbrotoseDietary 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
PlaceboOther
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| 2 grams Ambrotose LIFE | Experimental | 2 grams daily for 8 weeks Receives: Dietary Supplement: Ambrotose LIFE |
| 4 grams Ambrotose LIFE | Experimental | 4 grams daily for 8 weeks Receives: Dietary Supplement: Ambrotose LIFE |
| 2 grams Advanced Ambrotose | Active comparator | 2 grams daily for 8 weeks Receives: Dietary Supplement: Advanced Ambrotose |
| 4 grams Advanced Ambrotose | Active comparator | 4 grams daily for 8 weeks Receives: Dietary Supplement: Advanced Ambrotose |
| Placebo | Placebo comparator | 4 grams Maltodextrin daily for 8 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at baseline
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
Measured: at 4 weeks
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
Measured: at 8 weeks
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: at 8 weeks
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"
Measured: at baseline
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"
Measured: at 4 weeks
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"
Measured: at 8 weeks
White blood cell numbers
We determined the white blood cell numbers for each subject during their intervention.
Measured: at baseline
White blood cell numbers
We determined the white blood cell numbers for each subject during their intervention.
Measured: at 4 weeks
White blood cell numbers
We determined the white blood cell numbers for each subject during their intervention.
Measured: at 8 weeks
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
Measured: at baseline
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
Measured: at 4 weeks
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
Measured: at 8 weeks
Interleukin-6 (IL-6) level following blood incubation
IL-6 was measured following blood incubation with RPMI medium for 6 hrs
Measured: at baseline
Interleukin-6 (IL-6) level following blood incubation
IL-6 was measured following blood incubation with RPMI medium for 6 hrs
Measured: at 4 weeks
Interleukin-6 (IL-6) level following blood incubation
IL-6 was measured following blood incubation with RPMI medium for 6 hrs
Measured: at 8 weeks
Interleukin-1beta (IL-1beta) level following blood incubation
IL-1beta was measured following blood incubation with RPMI medium for 6 hrs
Measured: at baseline
Interleukin-1beta (IL-1beta) level following blood incubation
IL-1beta was measured following blood incubation with RPMI medium for 6 hrs
Measured: at 4 weeks
Interleukin-1beta (IL-1beta) level following blood incubation
IL-1beta was measured following blood incubation with RPMI medium for 6 hrs
Measured: at 8 weeks
Tumor Necrosis Factor alpha (TNFalpha) level following blood incubation
TNFalpha was measured following blood incubation with RPMI medium for 6 hrs
Measured: at baseline
Tumor Necrosis Factor alpha (TNFalpha) level following blood incubation
TNFalpha was measured following blood incubation with RPMI medium for 6 hrs
Measured: at 4 weeks
Tumor Necrosis Factor alpha (TNFalpha) level following blood incubation
TNFalpha was measured following blood incubation with RPMI medium for 6 hrs
Measured: at 8 weeks
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
Measured: at baseline
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
Measured: at 4 weeks
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
Measured: at 8 weeks
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
Measured: at baseline
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
Measured: at 4 weeks
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
Measured: at 8 weeks
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
Measured: at baseline
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
Measured: at 4 weeks
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
Measured: at 8 weeks
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
Measured: at baseline
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
Measured: at 4 weeks
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
Measured: at 8 weeks
Serum Zonulin levels
Zonulin from blood serum during the intervention was measured using an ELISA
Measured: at baseline
Serum Zonulin levels
Zonulin from blood serum during the intervention was measured using an ELISA
Measured: at 4 weeks
Serum Zonulin levels
Zonulin from blood serum during the intervention was measured using an ELISA
Measured: at 8 weeks
Secondary outcomes (3)
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
Measured: at baseline
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
Measured: at 4 weeks
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
Measured: at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start15 Aug 2018
- Primary completion15 Mar 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-Blind, Randomized, Control
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- Mannatech, Inc
- Responsible party
- Principal investigator, Richard Bloomer, University of Memphis
- Investigators
- Richard Bloomer, PhD, Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386226
- Sponsor's protocol ID
- PRO-FY2018-488
- Status last verified
- Apr 2021
- First submitted
- 5 May 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Glyconutrient Ambrotose™ on Immunity, Gut Health, and Safety in Men and Women: a Placebo-controlled, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04386226
- Acronym / sponsor ID
- PRO-FY2018-488
- Conditions
- Healthy
- Keywords
- Ambrotose, Immunity, Gut Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- Mannatech, Inc
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Double-Blind, Randomized, Control
| Arm | Type | Receives |
|---|---|---|
| 2 grams Ambrotose LIFE | Experimental | Dietary Supplement: Ambrotose LIFE2 grams daily for 8 weeks |
| 4 grams Ambrotose LIFE | Experimental | Dietary Supplement: Ambrotose LIFE4 grams daily for 8 weeks |
| 2 grams Advanced Ambrotose | Active comparator | Dietary Supplement: Advanced Ambrotose2 grams daily for 8 weeks |
| 4 grams Advanced Ambrotose | Active comparator | Dietary Supplement: Advanced Ambrotose4 grams daily for 8 weeks |
| Placebo | Placebo comparator | Other: Placebo4 grams Maltodextrin daily for 8 weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- must be physically active by participating in structured exercise at least twice per week for 30 or more minutes per session;
- not be pregnant
Key exclusion criteria (4 listed)
- diagnosed cardiovascular disease
- diagnosed metabolic disease
- diagnosed neurological disease
- using nutritional supplements or medications known to impact immunity or gut health
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambrotose LIFEAmbrotose 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. | Dietary supplement | 2 grams Ambrotose LIFE, 4 grams Ambrotose LIFE |
| Advanced AmbrotoseAdvanced 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 | Dietary supplement | 2 grams Advanced Ambrotose, 4 grams Advanced Ambrotose |
| PlaceboMaltodextrin | Other | Placebo |
Primary outcome
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
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
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
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)
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)
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)
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"
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"
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"
White blood cell numbers
Time frame: at baseline
We determined the white blood cell numbers for each subject during their intervention.
White blood cell numbers
Time frame: at 4 weeks
We determined the white blood cell numbers for each subject during their intervention.
White blood cell numbers
Time frame: at 8 weeks
We determined the white blood cell numbers for each subject during their intervention.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Serum Zonulin levels
Time frame: at baseline
Zonulin from blood serum during the intervention was measured using an ELISA
Serum Zonulin levels
Time frame: at 4 weeks
Zonulin from blood serum during the intervention was measured using an ELISA
Serum Zonulin levels
Time frame: at 8 weeks
Zonulin from blood serum during the intervention was measured using an ELISA
3 secondary outcomes
Dietary Intake
Time frame: at baseline
Dietary Intake
Time frame: at 4 weeks
Dietary Intake
Time frame: at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Bloomer, PhD principal investigator
University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambrotose LIFE and Advanced Ambrotose in people with Healthy, run by University of Memphis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
general well-being (Short Form-12) (time frame: at baseline). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.