HealthyHOPNCT03383341
What's Hopping? Cricket Protein and Human Gut Microbiota
A study testing Cricket Protein Powder in people with Healthy, run by Colorado State University at 1 site in United States.
Trial summary
Edible insects are often considered a nutritious, protein-rich, environmentally sustainable alternative to traditional meat. They represent a new food for North American consumers. While the nutrient composition of several insects is characterized, all potential health impacts have not been evaluated. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cricket Protein Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 10 May 2017
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy males and non-pregnant or lactating healthy females of any race or ethnicity and between the ages of 18-65 with a BMI between 18.5-29.9.
Who cannot join
- Individuals younger than 18 years of age or older than 65 years, and those outside of the BMI range of 18.5-29.9 will be excluded. Individuals will also be excluded if they have taken antibiotics or commercial probiotic/prebiotic supplements within two months of the start of the study treatment. Subjects who self-report food allergies will be excluded from the study because some proteins in insect foods are similar to those found in shellfish that could trigger an allergic reaction and tree nut or dairy products may be used in the breakfast foods.
- Additionally, current medications and dietary supplements will be assessed on a case by case basis and will result in exclusion if there is a possibility that the drugs or supplements used would influence the endpoints of the study. This would include statins, metformin, non-steroidal anti-inflammatory drugs (NSAID), Monoamine oxidase inhibitors (MAOI), and botanical supplements that target the gastrointestinal tract or gut microbiota. Individuals with current diagnosis of cancer, liver or kidney disease, gastrointestinal diseases, and metabolic disorders will also be excluded. Pregnant and breastfeeding women will be excluded from the study as well. Additionally, exclusion will be determined if the individual feels they are unable to adhere to the study requirements which include consuming 1 prepared breakfast per day (treatment or placebo) for a total of 28 days (treatment periods), making 3 clinic visits, and providing 3 blood and stool samples.
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University
Fort Collins, Colorado, 80523-1571
About this study
Official title: What's Hopping? Edible Cricket (Gryllodes Sigillatus) Consumption and Gut Microbiota in Healthy Adults, a Double-blind, Randomized Crossover Trial
Edible insects are often considered a nutritious, protein-rich, environmentally sustainable alternative to traditional meat. They represent a new food for North American consumers. While the nutrient composition of several insects is characterized, all potential health impacts have not been evaluated. Crickets contain chitin and other fibers that may influence gut health. In this study, we evaluated the effects of consuming 25 grams/day whole cricket powder on gut microbiota composition, while assessing safety and tolerability. Twenty healthy adults participated in this six-week, double-blind, crossover dietary intervention. Participants were randomized into two treatment arms and consumed either cricket-containing or control breakfast foods for 14 days, followed by a 14-day washout period and assignment to the opposite arm. Blood and stool samples were collected at baseline and after each treatment period to assess liver function and microbiota changes. Results demonstrate that cricket consumption is tolerable and non-toxic at the treatment dose. Cricket powder supported growth of the probiotic bacteria, Bifidobacterium animalis, which increased more than 5.7-fold. Cricket consumption was also associated with reduced plasma TNF-a. These data suggest that eating crickets may improve gut health and reduce systemic inflammation; however, more research is needed to understand these effects and underlying mechanisms.
Read the detailed description
Although no research on the impact of edible insect protein powder on the human microbiome, there is plenty of evidence that edible insects offer a good source nutrition. Extensive research demonstrates that edible insects provide a source of high-quality bioavailable animal protein as many edible insects contain all essential amino acids for human nutrition and have high crude protein levels containing between 40 and 75% protein by dry weight. House crickets, for example, have more protein by dry weight than ground beef or broiled cod fish. Insects are also rich in healthy fatty acids, B vitamins (riboflavin, pantothenic acid, biotin, and folate, as well as important minerals such as iron and zinc. In addition to their nutrient content, and as arthropods, edible insects are also rich in dietary fiber, including chitin, which is found in the exoskeleton.
Chitin is a modified polysaccharide containing nitrogen; it is considered an insoluble fiber with potential prebiotic properties that could benefit human health by selectively promoting the growth of beneficial bacterial species in the intestines. Previous studies on the impact of chitin-glucan derived from Aspergillus niger mycelium on oxidized low-density lipoprotein (OxLDL) in adults, a risk factor for atherosclerosis, found that chitin-glucan intakes of 4.5g/day significantly reduced OxLDL in 6 weeks. Additionally, a study of chito-oligosaccharides found that chitosan derivatives from shrimp cells with a great content of acetylated residues did not cause a putatively prebiotic effect in human gut microbiota-although this study was conducted on human fecal microbiota in batch cultures (not in humans). To date, no comprehensive study has evaluated the impact of whole insect consumption on the microbiota in humans, which would include consumption of insect-derived dietary fibers and chitins with potential health benefits. An assessment of the tolerability of whole insect consumption is also needed, despite the fact that around 2 billion people consume insects on a regular basis in 130 countries or more.
The "What's Hopping? Cricket Protein and Human Gut Microbiota" study will determine the impact of a commercially available insect flour, containing high levels of protein and dietary fiber on human gut bacterial composition and functional capacity. A secondary aim is to establish whether insect powder acts as a prebiotic. In this study, a 100% insect-based flour/powder derived from edible crickets (Acheta domesticus) will be assessed. The objective of this study is to determine if Insect powder consumption changes gut bacteria and reduces inflammation in your intestinal tract compared to a placebo. To this end, we intend to enroll 20 healthy individuals to participate in a crossover diet intervention study. Participants will consume meals made with cricket powder and placebo meals daily for 2 weeks per treatment arm with a 2-week washout period. Both study participants and study personnel (clinical coordinators, PI's, statisticians) will be blinded to the intervention group. Anthropometric measures, as well as stool and blood samples, will be collected at each of 3 clinic visits (baseline, and the end of each intervention period). Primary outcome measures will include gut microbiota and microbial metabolism (determined by measuring fecal short chain fatty acids), local and systemic inflammatory markers, comprehensive metabolic panels and GI health questionnaires to assess safety and tolerability of the intervention foods.
- Conditions
- Healthy
- Being tested
- Cricket Protein Powder, Placebo control
- Keywords
- gut microbiota, cricket powder, prebiotic fiber, inflammation, dietary intervention
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cricket Protein PowderDietary supplement
Cricket powder was supplied by Entomo farms and consists of roasted and milled whole crickets.
Placebo controlOther
Placebo controls consisted of intervention foods (muffin and smoothie powder packet) that were visually and organoleptically similar to cricket-containing foods but contained no cricket powder.
| Study group | Role | What they receive |
|---|---|---|
| Cricket powder protein | Experimental | Participants were provided with frozen 70 gram breakfast muffins and pre-mixed powder packets to prepare smoothies. Participants were asked to consume one muffin package and one smoothie (mixed with water or choice of milk/milk substitutes) daily for 14 days. The amount of intervention food consumed daily contained 25 grams of cricket protein powder. Receives: Dietary Supplement: Cricket Protein Powder |
| Placebo Control | Placebo comparator | Participants were provided with a placebo comparator that included frozen 70 gram breakfast muffins and pre-mixed powder packets to prepare smoothies. Participants were asked to consume one muffin package and one smoothie (mixed with water or choice of milk/milk substitutes) daily for 14 days. These foods were formulated to taste and appear similar to the cricket intervention foods but did not consume any cricket powder. Receives: Other: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gut microbiota with intervention foods
Characterization of microbes in fecal samples using 16s sequencing methodologies.
Measured: T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.
Secondary outcomes (6)
Change in liver function with intervention foods
Comprehensive metabolic panel
Measured: T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.
Tolerability of intervention foods based on change in GI symptoms
Self assessment of gastrointestinal symptoms determined by completion of a questionnaire
Measured: T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.
Change in mucosal immunity with intervention foods
ELISA analysis of secretory Immunoglobulin A (sIgA) in stool samples
Measured: T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.
Change in microbial metabolism with intervention foods
Gas Chromatography determination of fecal short chain fatty acids
Measured: T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.
Change in lipid metabolism with intervention foods
Liquid Chromatography determination of fecal secondary and primary bile acids
Measured: T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.
Change in systemic inflammation with intervention foods
Luminex panel to examine 13 circulating cytokines (pro and anti-inflammatory)
Measured: T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start1 Feb 2017
- Primary completion10 May 2017
- Study completion10 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, placebo controlled crossover dietary intervention
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Principal investigator, Tiffany Weir, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383341
- Sponsor's protocol ID
- 16-6966H
- Acronym
- HOP
- Status last verified
- Apr 2019
- First submitted
- 14 Dec 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stull VJ, Finer E, Bergmans RS, Febvre HP, Longhurst C, Manter DK, Patz JA, Weir TL. Impact of Edible Cricket Consumption on Gut Microbiota in Healthy Adults, a Double-blind, Randomized Crossover Trial. Sci Rep. 2018 Jul 17;8(1):10762. doi: 10.1038/s41598-018-29032-2.
PubMed 30018370
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What's Hopping? Edible Cricket (Gryllodes Sigillatus) Consumption and Gut Microbiota in Healthy Adults, a Double-blind, Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT03383341
- Acronym / sponsor ID
- HOP / 16-6966H
- Conditions
- Healthy
- Keywords
- gut microbiota, cricket powder, prebiotic fiber, inflammation, dietary intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 10 May 2017 (actual)
- Study completion
- 10 May 2017 (actual)
- First posted
- 26 Dec 2017 (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.
Edible insects are often considered a nutritious, protein-rich, environmentally sustainable alternative to traditional meat. They represent a new food for North American consumers. While the nutrient composition of several insects is characterized, all potential health impacts have not been evaluated. Crickets contain chitin and other fibers that may influence gut health. In this study, we evaluated the effects of consuming 25 grams/day whole cricket powder on gut microbiota composition, while assessing safety and tolerability. Twenty healthy adults participated in this six-week, double-blind, crossover dietary intervention. Participants were randomized into two treatment arms and consumed either cricket-containing or control breakfast foods for 14 days, followed by a 14-day washout period and assignment to the opposite arm. Blood and stool samples were collected at baseline and after each treatment period to assess liver function and microbiota changes. Results demonstrate that cricket consumption is tolerable and non-toxic at the treatment dose. Cricket powder supported growth of the probiotic bacteria, Bifidobacterium animalis, which increased more than 5.7-fold. Cricket consumption was also associated with reduced plasma TNF-a. These data suggest that eating crickets may improve gut health and reduce systemic inflammation; however, more research is needed to understand these effects and underlying mechanisms.
Detailed description
Although no research on the impact of edible insect protein powder on the human microbiome, there is plenty of evidence that edible insects offer a good source nutrition. Extensive research demonstrates that edible insects provide a source of high-quality bioavailable animal protein as many edible insects contain all essential amino acids for human nutrition and have high crude protein levels containing between 40 and 75% protein by dry weight. House crickets, for example, have more protein by dry weight than ground beef or broiled cod fish. Insects are also rich in healthy fatty acids, B vitamins (riboflavin, pantothenic acid, biotin, and folate, as well as important minerals such as iron and zinc. In addition to their nutrient content, and as arthropods, edible insects are also rich in dietary fiber, including chitin, which is found in the exoskeleton.
Chitin is a modified polysaccharide containing nitrogen; it is considered an insoluble fiber with potential prebiotic properties that could benefit human health by selectively promoting the growth of beneficial bacterial species in the intestines. Previous studies on the impact of chitin-glucan derived from Aspergillus niger mycelium on oxidized low-density lipoprotein (OxLDL) in adults, a risk factor for atherosclerosis, found that chitin-glucan intakes of 4.5g/day significantly reduced OxLDL in 6 weeks. Additionally, a study of chito-oligosaccharides found that chitosan derivatives from shrimp cells with a great content of acetylated residues did not cause a putatively prebiotic effect in human gut microbiota-although this study was conducted on human fecal microbiota in batch cultures (not in humans). To date, no comprehensive study has evaluated the impact of whole insect consumption on the microbiota in humans, which would include consumption of insect-derived dietary fibers and chitins with potential health benefits. An assessment of the tolerability of whole insect consumption is also needed, despite the fact that around 2 billion people consume insects on a regular basis in 130 countries or more.
The "What's Hopping? Cricket Protein and Human Gut Microbiota" study will determine the impact of a commercially available insect flour, containing high levels of protein and dietary fiber on human gut bacterial composition and functional capacity. A secondary aim is to establish whether insect powder acts as a prebiotic. In this study, a 100% insect-based flour/powder derived from edible crickets (Acheta domesticus) will be assessed. The objective of this study is to determine if Insect powder consumption changes gut bacteria and reduces inflammation in your intestinal tract compared to a placebo. To this end, we intend to enroll 20 healthy individuals to participate in a crossover diet intervention study. Participants will consume meals made with cricket powder and placebo meals daily for 2 weeks per treatment arm with a 2-week washout period. Both study participants and study personnel (clinical coordinators, PI's, statisticians) will be blinded to the intervention group. Anthropometric measures, as well as stool and blood samples, will be collected at each of 3 clinic visits (baseline, and the end of each intervention period). Primary outcome measures will include gut microbiota and microbial metabolism (determined by measuring fecal short chain fatty acids), local and systemic inflammatory markers, comprehensive metabolic panels and GI health questionnaires to assess safety and tolerability of the intervention foods.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo controlled crossover dietary intervention
| Arm | Type | Receives |
|---|---|---|
| Cricket powder protein | Experimental | Dietary Supplement: Cricket Protein PowderParticipants were provided with frozen 70 gram breakfast muffins and pre-mixed powder packets to prepare smoothies. Participants were asked to consume one muffin package and one smoothie (mixed with water or choice of milk/milk substitutes) daily for 14 days. The amount of intervention food consumed daily contained 25 grams of cricket protein powder. |
| Placebo Control | Placebo comparator | Other: Placebo controlParticipants were provided with a placebo comparator that included frozen 70 gram breakfast muffins and pre-mixed powder packets to prepare smoothies. Participants were asked to consume one muffin package and one smoothie (mixed with water or choice of milk/milk substitutes) daily for 14 days. These foods were formulated to taste and appear similar to the cricket intervention foods but did not consume any cricket powder. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Apparently healthy males and non-pregnant or lactating healthy females of any race or ethnicity and between the ages of 18-65 with a BMI between 18.5-29.9.
Key exclusion criteria (2 listed)
- Individuals younger than 18 years of age or older than 65 years, and those outside of the BMI range of 18.5-29.9 will be excluded. Individuals will also be excluded if they have taken antibiotics or commercial probiotic/prebiotic supplements within two months of the start of the study treatment. Subjects who self-report food allergies will be excluded from the study because some proteins in insect foods are similar to those found in shellfish that could trigger an allergic reaction and tree nut or dairy products may be used in the breakfast foods.
- Additionally, current medications and dietary supplements will be assessed on a case by case basis and will result in exclusion if there is a possibility that the drugs or supplements used would influence the endpoints of the study. This would include statins, metformin, non-steroidal anti-inflammatory drugs (NSAID), Monoamine oxidase inhibitors (MAOI), and botanical supplements that target the gastrointestinal tract or gut microbiota. Individuals with current diagnosis of cancer, liver or kidney disease, gastrointestinal diseases, and metabolic disorders will also be excluded. Pregnant and breastfeeding women will be excluded from the study as well. Additionally, exclusion will be determined if the individual feels they are unable to adhere to the study requirements which include consuming 1 prepared breakfast per day (treatment or placebo) for a total of 28 days (treatment periods), making 3 clinic visits, and providing 3 blood and stool samples.
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 |
|---|---|---|
| Cricket Protein PowderCricket powder was supplied by Entomo farms and consists of roasted and milled whole crickets. | Dietary supplement | Cricket powder protein |
| Placebo controlPlacebo controls consisted of intervention foods (muffin and smoothie powder packet) that were visually and organoleptically similar to cricket-containing foods but contained no cricket powder. | Other | Placebo Control |
Primary outcome
Change in gut microbiota with intervention foods
Time frame: T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.
Characterization of microbes in fecal samples using 16s sequencing methodologies.
6 secondary outcomes
Change in liver function with intervention foods
Time frame: T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.
Tolerability of intervention foods based on change in GI symptoms
Time frame: T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.
Change in mucosal immunity with intervention foods
Time frame: T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.
Change in microbial metabolism with intervention foods
Time frame: T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.
Change in lipid metabolism with intervention foods
Time frame: T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.
Change in systemic inflammation with intervention foods
Time frame: T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.
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 4 Apr 2019.
- Results publication: PubMed 30018370Stull VJ, Finer E, Bergmans RS, Febvre HP, Longhurst C, Manter DK, Patz JA, Weir TL. Impact of Edible Cricket Consumption on Gut Microbiota in Healthy Adults, a Double-blind, Randomized Crossover Trial. Sci Rep. 2018 Jul 17;8(1):10762. doi: 10.1038/s41598-018-29032-2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cricket Protein Powder in people with Healthy, run by Colorado State University 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 1 inclusion and 2 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 4 Apr 2019. 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?
Change in gut microbiota with intervention foods (time frame: T=0; Baseline visit prior to starting diet intervention, T1: End of Treatment 1 (2-weeks after the start of intervention), T2: End of study (approximately 6-weeks after T=0 and 2-weeks after starting treatment 2.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03383341, which also lists 1 linked publication.
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 4 Apr 2019.