Appetitive BehaviorStrucSatNCT04289883
Food Structure and Satiety
A study of Appetitive Behavior, run by Arne Astrup at 1 site in Denmark.
Trial summary
Based on in vitro studies identifying changes in food structures potential to delay digestion as well as results from animal studies showing potential of these foods to decrease appetite, nano-particulated whey protein and high molecular weight whey protein-alginate coacervates were chosen to be investigated in… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Apr 2020to 30 Jun 2020
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who have provided written informed consent
- Healthy men and women (at least 40% of each gender)
- Age between 18 and 45 years
- BMI between 22.0-30.0 kg/m2
- Regular breakfast eaters (eating breakfast ≥ 4 times a week)
Who cannot join
- Participants unable to consume the test products (the test product will be presented at screening)
- Participants not able to comply with the study protocol, including consumption of the specific study foods served during lunch and in the snack box (the study foods will be presented at screening)
- Any known food allergies or food intolerance likely to affect the present study
- Significant health problems as judged by the principal investigator
- Taking any medication or supplements known to affect appetite or body weight within the past month and/or during the study, as judged by the principal investigator
- Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes, gum etc.). Irregular smokers accepted
Show all 12Show fewer
- Self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months
- Significant weight changes (±3 kg) over the course of the study (from screening to completion of last appetite probe day)
- Significant changes in physical activity patterns in the past 4 weeks or significant changes over the course of the study (from screening to completion of last appetite probe day), as judged by the sub-investigator
- Significant changes in diet in the past 4 weeks or significant changes over the course of the study (from screening to completion of last appetite probe day) as judged by the sub-investigator
- Participants who work in appetite related areas
- Simultaneous or within the past month participating in other clinical trials that can interfere with the study
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports, University of Copenhagen
Copenhagen, Frederiksberg, 1958
About this study
Official title: Nano-particulated and Alginate Whey Protein's Effects on Appetite - Food Structure Approaches Developed Within the StrucSat Project
Based on in vitro studies identifying changes in food structures potential to delay digestion as well as results from animal studies showing potential of these foods to decrease appetite, nano-particulated whey protein and high molecular weight whey protein-alginate coacervates were chosen to be investigated in humans. Thereby, the aim of this short-term study is to investigate if nano-particulated whey protein has appetite reducing effects in humans compared to non-particulated whey protein (Part 1) as well as if high molecular weight whey protein-alginate coacervates have appetite reducing effects in humans compared to calcium alginate (Part 2).
Read the detailed description
Based on animal studies in mice, nano-particulated whey protein and high molecular weight whey protein-alginate coacervates are expected to have appetite reducing (and potentially also other) effects, which potentially may be beneficial for body weight management. In order to investigate these effects in humans, this study is divided into two parts (Part 1 and Part 2), of which the specific objectives are specified below:
Part 1: The objective of this part of the study is to examine if nano-particulated whey protein can reduce appetite compared with non-particulated whey protein.
Part 2: The objective of this part of the study is to examine if high molecular weight whey protein-alginate coacervates can reduce appetite compared to calcium alginate.
A double-blind, randomised crossover design with four arms divided into the two parts will be applied. After having successfully completed screening procedures, eligible participants will be invited to two separate appetite probe days with particulated whey protein followed by at least 14 days break followed by another two separate appetite probe days with the whey protein-alginate coacervates. The appetite probe days must be separated by at least 7 days, but there is no upper limit for days in between, as long as the participants remain weight stable and do not change diet or physical activity level significantly. The study includes a total of five visits to the study site.
For standardisation, 48 hours before the appetite probe days, the participants will be asked to consume a regular diet compliant to what they usually eat and no excessive alcohol consumption (not above 5 units and no alcohol at all from 8 pm the night before the appetite probe days) or intense physical activity is allowed. Within each part of the study, the participants will be instructed to consume similar meals the evening before the appetite probe days and the meal must be consumed at approximately the same time. The participants will also be instructed to go to bed at the same time in the evening prior to the appetite probe days. Additionally, the participants must arrive at the study facilities in the morning after an overnight fast (from 10 pm) using non strenuous means of transportation. Furthermore, over the course of the study (from screening (visit 1) to completion of the last appetite probe day (visit 5)), the participants are not allowed to change body weight (±3 kg), diet or physical activity level (as judged by the sub-investigator). The participants will be weighed and asked about compliance with additional standardisation criteria in a room away from the other participants before initiating each appetite probe day. Possible non-compliance with the standardisation will be judged whether to result in re-scheduling of the visit or to be recorded as a protocol deviation.
Participants arrive at the study facility in the morning. Compliance with standardisation is controlled along with registration of possible adverse events and use of concomitant medications. During the appetite probe days, participants are settled together in an open office, where they are separated at individual tables. During the ad libitum lunch, participants are settled into individual feeding cubicles, where they cannot see each other and are instructed not to talk to each other.
VAS' will be completed for measurement of fasting levels of self-reported appetite.
The test products will be provided as a standardised fixed breakfast and as a standardised fixed mid-morning meal provided 3 hour and 1 hour prior to the ad libitum lunch, respectively.
Immediately before and after the test products and the ad libitum lunch and at 30 minutes intervals, VAS' will be completed assessing self-reported appetite.
After the ad libitum lunch, the participants will be free to leave the laboratory. They will be provided with a snack box including a variety of foods to including a ready-to-heat dish for dinner etc. providing approximately 10000 kJ. The participants will be instructed only to consume foods and drinks (water excepted) from the snack box for the remaining of the days, and to be focussed while eating and only eat until feeling comfortably full. The participants will be instructed to complete a diary registering the time point of consumption of which items from the snack box (and potential additional items). If consuming any foods or energy containing drinks besides those provided in the snack box, the participants will be instructed to register the type and amount consumed. Within the diary, the participants will also be instructed to register the time of going to bed on the day of the appetite probe day. At the second appetite probe day within each part of the study, the participants will be instructed to go to bed at approximately the same time as registered at the first appetite probe day within each part of the study. On the following day after each appetite probe day, the participants will be instructed to hand in the leftovers from the snack box and the diary at the research facility.
- Conditions
- Appetitive Behavior
- Being tested
- Nano-particulated whey protein vs non-particulated whey protein (control), High molecular weight whey protein-alginate coacervates vs calcium alginate (control)
- Keywords
- Satiety, Appetite, Food structure
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano-particulated whey protein vs non-particulated whey protein (control)Combination product
Different particularisations of whey protein were identified to potentially delay digestion based on in vitro studies and to potentially affect appetite and body weight based on animal studies compared to non-particulated whey protein, with nano-particulated whey protein suggested to be more efficient than micro-particulated.
High molecular weight whey protein-alginate coacervates vs calcium alginate (control)Combination product
Different whey protein-alginate coacervates were identified to potentially delay digestion based on in vitro studies and to potentially affect appetite based on animal studies compared to calcium alginate, with high molecular weight alginate suggested to be more efficient than low molecular weight alginate.
| Study group | Role | What they receive |
|---|---|---|
| High molecular weight whey protein-alginate/Calcium alginate | Experimental | Produced from whey protein with different structures (nano-particulated vs. non-particulated whey proteins and high molecular weight whey protein-alginate coacervates vs. calcium alginate) added cream, sucrose and lactose in order for the products to contain all macronutrients and in equal amounts between the intervention and the control products. Additionally, vanilla flavour (Dr. Oetker vanilla extract) is added in order for the test products to taste similar to "koldskål" (a well-known Danish food). All test products will be produced in the dairy pilot plant at Department of Food Science at University of Copenhagen prior to performance of the appetite probe days. All test products will have a pH of 4 and will be manufactured from dry (powdered) ingredients and pasteurized cream. They will be kept refrigerated for a maximum of 3 days prior to use and production will be planned accordingly. Receives: Combination Product: High molecular weight whey protein-alginate coacervates vs calcium alginate (control) |
| Nano-particulated whey protein/Non-particulated whey protein | Experimental | Produced from whey protein with different structures (nano-particulated vs. non-particulated whey proteins and high molecular weight whey protein-alginate coacervates vs. calcium alginate) added cream, sucrose and lactose in order for the products to contain all macronutrients and in equal amounts between the intervention and the control products. Additionally, vanilla flavour (Dr. Oetker vanilla extract) is added in order for the test products to taste similar to "koldskål" (a well-known Danish food). All test products will be produced in the dairy pilot plant at Department of Food Science at University of Copenhagen prior to performance of the appetite probe days. All test products will have a pH of 4 and will be manufactured from dry (powdered) ingredients and pasteurized cream. They will be kept refrigerated for a maximum of 3 days prior to use and production will be planned accordingly. Receives: Combination Product: Nano-particulated whey protein vs non-particulated whey protein (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour energy intake (kJ)
Difference in 24-hour energy intake (the total energy intake from the test products, the ad libitum lunch and the ad libitum snack box) between exposure to the experimental conditions compared to the matching control conditions.
Measured: 24 hour
Secondary outcomes (5)
Energy intake (kJ) at each of the ad libitum meals
Difference in energy intake at each of the ad libitum meals (lunch and snack box) between exposure to the experimental conditions compared to the matching control conditions.
Measured: Lunch: 30 minutes; Snack box: from 12.00 pm until going to bed (app. 11 hour)
Visual analogue scales (VAS) of self-reported appetite assessed throughout the appetite probe days while being in the laboratory
Difference in perceptions of satiety, fullness, hunger and predicted prospective food consumption between exposure to the experimental conditions compared to the matching control conditions using VAS (0-100 mm with 0 indicating no hunger or perccieved ability to consume food / no satiety or no fullness).
Measured: 3 hour
Satiety quotient (SQ)
Difference in SQ between exposure to the experimental conditions compared to the matching control conditions is assessed by analysing the VAS assessments before and after the ad libitum lunch in relation to the energy consumed at the test meal will be assessed.
Measured: 30 minutes
Visual analogue scales of self-reported nausea and well-being assessed throughout the appetite probe days while being in the laboratory
Difference in perceptions of nausea and well-being between exposure to the experimental conditions compared to the matching control conditions using VAS (0-100 mm with 0 indicating no nausea).
Measured: 3 hour
Visual analogue scales of self-reported product palatability
Difference in perceptions of palatability of the test products between exposure to the experimental conditions compared to the matching control conditions using VAS (0-100 mm with 0 indicating low palatability of the product).
Measured: 5 minutes (assessed after both exposures at each appetite probe day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start25 Apr 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Why it stopped: The Covid-19 pandemic that made it impossible to conduct within the timeframe.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A double-blind, randomised crossover design with four arms divided into two parts.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arne Astrup
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Technical University of Denmark, DuPont Nutrition and Health, Arla Foods
- Responsible party
- Sponsor-investigator, Arne Astrup, University of Copenhagen
- Investigators
- Anders Sjödin, PhD, Principal investigator, University of Copenhagen, Department of Nutrition, Exercise and Sports
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289883
- Sponsor's protocol ID
- B311
- Acronym
- StrucSat
- Status last verified
- May 2020
- First submitted
- 13 Feb 2020
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nano-particulated and Alginate Whey Protein's Effects on Appetite - Food Structure Approaches Developed Within the StrucSat Project
- ClinicalTrials.gov ID
- NCT04289883
- Acronym / sponsor ID
- StrucSat / B311
- Conditions
- Appetitive Behavior
- Keywords
- Satiety, Appetite, Food structure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Covid-19 pandemic that made it impossible to conduct within the timeframe.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Arne AstrupUniversity, hospital or other
- Collaborators
- University of Copenhagen, Technical University of Denmark, DuPont Nutrition and Health, Arla Foods
- Study start
- 25 Apr 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 28 Feb 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.
Based on in vitro studies identifying changes in food structures potential to delay digestion as well as results from animal studies showing potential of these foods to decrease appetite, nano-particulated whey protein and high molecular weight whey protein-alginate coacervates were chosen to be investigated in humans. Thereby, the aim of this short-term study is to investigate if nano-particulated whey protein has appetite reducing effects in humans compared to non-particulated whey protein (Part 1) as well as if high molecular weight whey protein-alginate coacervates have appetite reducing effects in humans compared to calcium alginate (Part 2).
Detailed description
Based on animal studies in mice, nano-particulated whey protein and high molecular weight whey protein-alginate coacervates are expected to have appetite reducing (and potentially also other) effects, which potentially may be beneficial for body weight management. In order to investigate these effects in humans, this study is divided into two parts (Part 1 and Part 2), of which the specific objectives are specified below:
Part 1: The objective of this part of the study is to examine if nano-particulated whey protein can reduce appetite compared with non-particulated whey protein.
Part 2: The objective of this part of the study is to examine if high molecular weight whey protein-alginate coacervates can reduce appetite compared to calcium alginate.
A double-blind, randomised crossover design with four arms divided into the two parts will be applied. After having successfully completed screening procedures, eligible participants will be invited to two separate appetite probe days with particulated whey protein followed by at least 14 days break followed by another two separate appetite probe days with the whey protein-alginate coacervates. The appetite probe days must be separated by at least 7 days, but there is no upper limit for days in between, as long as the participants remain weight stable and do not change diet or physical activity level significantly. The study includes a total of five visits to the study site.
For standardisation, 48 hours before the appetite probe days, the participants will be asked to consume a regular diet compliant to what they usually eat and no excessive alcohol consumption (not above 5 units and no alcohol at all from 8 pm the night before the appetite probe days) or intense physical activity is allowed. Within each part of the study, the participants will be instructed to consume similar meals the evening before the appetite probe days and the meal must be consumed at approximately the same time. The participants will also be instructed to go to bed at the same time in the evening prior to the appetite probe days. Additionally, the participants must arrive at the study facilities in the morning after an overnight fast (from 10 pm) using non strenuous means of transportation. Furthermore, over the course of the study (from screening (visit 1) to completion of the last appetite probe day (visit 5)), the participants are not allowed to change body weight (±3 kg), diet or physical activity level (as judged by the sub-investigator). The participants will be weighed and asked about compliance with additional standardisation criteria in a room away from the other participants before initiating each appetite probe day. Possible non-compliance with the standardisation will be judged whether to result in re-scheduling of the visit or to be recorded as a protocol deviation.
Participants arrive at the study facility in the morning. Compliance with standardisation is controlled along with registration of possible adverse events and use of concomitant medications. During the appetite probe days, participants are settled together in an open office, where they are separated at individual tables. During the ad libitum lunch, participants are settled into individual feeding cubicles, where they cannot see each other and are instructed not to talk to each other.
VAS' will be completed for measurement of fasting levels of self-reported appetite.
The test products will be provided as a standardised fixed breakfast and as a standardised fixed mid-morning meal provided 3 hour and 1 hour prior to the ad libitum lunch, respectively.
Immediately before and after the test products and the ad libitum lunch and at 30 minutes intervals, VAS' will be completed assessing self-reported appetite.
After the ad libitum lunch, the participants will be free to leave the laboratory. They will be provided with a snack box including a variety of foods to including a ready-to-heat dish for dinner etc. providing approximately 10000 kJ. The participants will be instructed only to consume foods and drinks (water excepted) from the snack box for the remaining of the days, and to be focussed while eating and only eat until feeling comfortably full. The participants will be instructed to complete a diary registering the time point of consumption of which items from the snack box (and potential additional items). If consuming any foods or energy containing drinks besides those provided in the snack box, the participants will be instructed to register the type and amount consumed. Within the diary, the participants will also be instructed to register the time of going to bed on the day of the appetite probe day. At the second appetite probe day within each part of the study, the participants will be instructed to go to bed at approximately the same time as registered at the first appetite probe day within each part of the study. On the following day after each appetite probe day, the participants will be instructed to hand in the leftovers from the snack box and the diary at the research facility.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind, randomised crossover design with four arms divided into two parts.
| Arm | Type | Receives |
|---|---|---|
| High molecular weight whey protein-alginate/Calcium alginate | Experimental | Combination Product: High molecular weight whey protein-alginate coacervates vs calcium alginate (control)Produced from whey protein with different structures (nano-particulated vs. non-particulated whey proteins and high molecular weight whey protein-alginate coacervates vs. calcium alginate) added cream, sucrose and lactose in order for the products to contain all macronutrients and in equal amounts between the intervention and the control products. Additionally, vanilla flavour (Dr. Oetker vanilla extract) is added in order for the test products to taste similar to "koldskål" (a well-known Danish food). All test products will be produced in the dairy pilot plant at Department of Food Science at University of Copenhagen prior to performance of the appetite probe days. All test products will have a pH of 4 and will be manufactured from dry (powdered) ingredients and pasteurized cream. They will be kept refrigerated for a maximum of 3 days prior to use and production will be planned accordingly. |
| Nano-particulated whey protein/Non-particulated whey protein | Experimental | Combination Product: Nano-particulated whey protein vs non-particulated whey protein (control)Produced from whey protein with different structures (nano-particulated vs. non-particulated whey proteins and high molecular weight whey protein-alginate coacervates vs. calcium alginate) added cream, sucrose and lactose in order for the products to contain all macronutrients and in equal amounts between the intervention and the control products. Additionally, vanilla flavour (Dr. Oetker vanilla extract) is added in order for the test products to taste similar to "koldskål" (a well-known Danish food). All test products will be produced in the dairy pilot plant at Department of Food Science at University of Copenhagen prior to performance of the appetite probe days. All test products will have a pH of 4 and will be manufactured from dry (powdered) ingredients and pasteurized cream. They will be kept refrigerated for a maximum of 3 days prior to use and production will be planned accordingly. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants who have provided written informed consent
- Healthy men and women (at least 40% of each gender)
- Age between 18 and 45 years
- BMI between 22.0-30.0 kg/m2
- Regular breakfast eaters (eating breakfast ≥ 4 times a week)
Key exclusion criteria (12 listed)
- Participants unable to consume the test products (the test product will be presented at screening)
- Participants not able to comply with the study protocol, including consumption of the specific study foods served during lunch and in the snack box (the study foods will be presented at screening)
- Any known food allergies or food intolerance likely to affect the present study
- Significant health problems as judged by the principal investigator
- Taking any medication or supplements known to affect appetite or body weight within the past month and/or during the study, as judged by the principal investigator
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 |
|---|---|---|
| Nano-particulated whey protein vs non-particulated whey protein (control)Different particularisations of whey protein were identified to potentially delay digestion based on in vitro studies and to potentially affect appetite and body weight based on animal studies compared to non-particulated whey protein, with nano-particulated whey protein suggested to be more efficient than micro-particulated. | Combination product | Nano-particulated whey protein/Non-particulated whey protein |
| High molecular weight whey protein-alginate coacervates vs calcium alginate (control)Different whey protein-alginate coacervates were identified to potentially delay digestion based on in vitro studies and to potentially affect appetite based on animal studies compared to calcium alginate, with high molecular weight alginate suggested to be more efficient than low molecular weight alginate. | Combination product | High molecular weight whey protein-alginate/Calcium alginate |
Primary outcome
24-hour energy intake (kJ)
Time frame: 24 hour
Difference in 24-hour energy intake (the total energy intake from the test products, the ad libitum lunch and the ad libitum snack box) between exposure to the experimental conditions compared to the matching control conditions.
5 secondary outcomes
Energy intake (kJ) at each of the ad libitum meals
Time frame: Lunch: 30 minutes; Snack box: from 12.00 pm until going to bed (app. 11 hour)
Visual analogue scales (VAS) of self-reported appetite assessed throughout the appetite probe days while being in the laboratory
Time frame: 3 hour
Satiety quotient (SQ)
Time frame: 30 minutes
Visual analogue scales of self-reported nausea and well-being assessed throughout the appetite probe days while being in the laboratory
Time frame: 3 hour
Visual analogue scales of self-reported product palatability
Time frame: 5 minutes (assessed after both exposures at each appetite probe day)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Individual participant dataSharing planned: No. No IPD will be shared
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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.
Anders Sjödin, PhD principal investigator
University of Copenhagen, Department of Nutrition, Exercise and Sports
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Appetitive Behavior, run by Arne Astrup at 1 site in Denmark.
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 5 inclusion and 12 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: withdrawn, as of the sponsor's last update on 29 May 2020. 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 Denmark. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
24-hour energy intake (kJ) (time frame: 24 hour). 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 29 May 2020.