Eating BehaviorESPANCT05019872
Al Dente or Well Done? The Eating Rate of a Pasta Meal Modified by Texture
A study testing (Components of) pasta meal in people with Eating Behavior, run by Wageningen University at 1 site in Netherlands.
Trial summary
Rationale: The world-wide rising obesity rates are a major health problem. Therefore, people should moderate food intake. A lower eating rate will decrease the energy intake. The eating rate of foods can be modified by changing the texture without affecting their acceptability. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior
- What is being tested?
- (Components of) pasta meal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Sep 2021to 9 Dec 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18-55 years old at the day of inclusion
- European nationality
- Able to understand and speak English fluently or without difficulty (self-report)
- BMI 18.5-30 kg/m2 (self-report)
- Good general health and appetite (self-report)
- Regular consumers of pasta with tomato sauce (commonly once or more per month)
Who cannot join
- Pregnant or lactating women
- Smoking
- Braces (not including a dental wire) or oral piercing
- Difficulties with swallowing, chewing and/or eating in general
- Suffering from an endocrine or eating disorder, gastrointestinal illness or illness of the thyroid gland, respiratory disease, or diabetes
- Having taste or smell disorders (self-report)
Show all 16Show fewer
- Use of medication that may influence study outcomes (self-report)
- Consuming on average more than 21 glasses of alcohol per week
- Not willing to stop using drugs during the study period (from inclusion till last test session)
- Intensive exercising more than eight hours per week
- Allergies or intolerance to any ingredient of the test meals
- Don't like pasta with tomato sauce or its ingredients (<five on a nine point Likert scale)
- Men having facial hair such as a beard as facial movements cannot be analyzed
- Signed up for participating in another research study
- Employee of Human Nutrition department of Wageningen university
- Employee, thesis student or intern at the chair group of Sensory Science and Eating Behaviour Human Nutrition or Food Quality and Design (WUR)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University, Human Nutrition Department
Wageningen, Gelderland, 6708 WE
About this study
Rationale: The world-wide rising obesity rates are a major health problem. Therefore, people should moderate food intake. A lower eating rate will decrease the energy intake. The eating rate of foods can be modified by changing the texture without affecting their acceptability. Harder, chunkier, more viscous, and more voluminous foods will decrease the eating rate and thus energy intake. However, the impact of texture on oral processing has mostly been studied as a model or single food system, whereas a diet consists of many different food products often consumed in combination. Little has been researched on the effect of food texture on eating rate within the context of realistic meals. It is not known if the eating rate of a meal is determined by the eating rate component with the lowest eating rate or if there is an additive effect of the eating rates of all components of the meal.
Objective: The aim of the ESPA study is to determine how the eating rate of a pasta meal can be changed by manipulating the hardness of the ingredients and to investigate if the eating rate of a meal is determined by the eating rate of the component with the lowest eating rate or if there is an additive effect of the eating rates of all components of the meal.
Read more
Study design: The study is a randomized crossover trial. All participants receive all pasta samples.
Study population: Healthy adults (n=50) between 18-55 years old with European nationality, and a BMI between 18.5-30 kg/m2.
Intervention: Participants will attend three test sessions during lunch in which in total twelve pasta samples will be consumed. The pasta samples will consists of individual or combined pasta noodles, vegetables, and sauce differing in hardness. The order of the samples will be randomized. After the consumption of the test samples, the participants will rate their appetite and the sensory characteristics of the samples. During the test sessions, participants will be video recorded to determine their eating behavior.
Main study parameters/endpoints: The main study outcome is the eating rate (g/min). Secondary outcomes are the oral processing characteristics assessed with the video recordings (meal duration [min], bite duration [min], number of bites, number of chews, average bite size [g], average amount of chews per bite, and oral sensory exposure time [min]) and sensory characteristics rated on a visual analogue scale (liking [flavor, texture, and overall], flavor intensity, sweetness, saltiness, sourness, hardness, and chewiness).
Read the detailed description
The study has a randomized crossover design with three test sessions. All participants receive twelve pasta samples (four per test session) and are their own control (within subject effects).
Participants attend three test sessions during which they eat four pasta samples. The pasta samples will have a fixed amount and differ in pasta noodle and vegetable hardness. Eight pasta samples will consist out of only penne or carrots with or without sauce. Four pasta samples will consist out of penne, carrots, and sauce. The sample order will be randomized, but in each test session only one or two of sample 9 to 12 will be served. The samples will be served on a plate together with a fork.
Procedure of the study:
Throughout study period :
- No use of drugs
- Medication use + illness should be reported
Evening preceding test day:
- Not allowed to eat or drink after 22.00 except for water
Morning of test day:
- Do not perform intensive exercise
- Eat the same breakfast at the same time each test day
- If wanted, eat the same morning snack at the same time each test day
- Not allowed to eat or drink two hours prior the study session except for water
- Have a negative corona test
Lunch
- Give instructions (eat as you normally would do, eat the whole sample without taking breaks or sips of water in between, you can take a new bite before you swallowed the previous one)
- Seated at sensory booth with fork, knife, spoon, 200 mL of water and three pieces of a plain cracker
- Question about food consumption that morning
- Appetite questionnaire
- Eat the pasta sample (one of twelve conditions) while recording eating behavior
- Sensory questionnaire
- Appetite questionnaire
- Taste neutralization by waiting for two minutes, taking sip of water and bite of cracker
- Repeat * ... * until four pasta samples are consumed
- Appetite questionnaire
Participants will be recruited from Wageningen and surroundings using an e-mailing list, social media, and flyers. Healthy (self-report), normal weight (18.5-30 kg/m2) men and women between 18-55 years old will be included. Participants need to have European nationality, and have to be able to understand and speak English (self-report), because of the sensory questionnaire and appetite questionnaire which will be in English and have difficult direct translations to Dutch. As 90% of the people that show interest in the study are university students this should not be a problem. The BMI range is based on the average BMI in the Netherlands, which is 25 kg/m2 but around 50% of the Dutch population is overweight. To be able to include sufficient subjects it was therefore chosen to widen the BMI range and include people up to a BMI of 30 kg/m2. Due to the within subject design this will not influence the outcome of the study, but results will be more generalizable to people with an average weight.
- Conditions
- Eating Behavior
- Being tested
- (Components of) pasta meal
- Keywords
- Eating rate, Pasta, Oral Processing, Eating Behaviour, Texture, Hardness
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Components of) pasta mealBehavioural
Samples will be provided one by one in cups labeled with an unique code.
| Study group | Role | What they receive |
|---|---|---|
| Penne hard | Active comparator | 20 g penne cooked for 7 minutes Receives: Behavioral: (Components of) pasta meal |
| Penne soft | Active comparator | 20 g penne cooked for 20 minutes Receives: Behavioral: (Components of) pasta meal |
| Carrot hard | Active comparator | 50 g diced carrot cooked for 2 minutes Receives: Behavioral: (Components of) pasta meal |
| Carrot soft | Active comparator | 50 g diced carrot cooked for 20 minutes Receives: Behavioral: (Components of) pasta meal |
| Penne hard + sauce | Active comparator | 20 g penne cooked for 7 minutes + 10 g tomato sauce Receives: Behavioral: (Components of) pasta meal |
| Penne soft + sauce | Active comparator | 20 g penne cooked for 20 minutes + 10 g tomato sauce Receives: Behavioral: (Components of) pasta meal |
| Carrot hard + sauce | Active comparator | 50 g diced carrot cooked for 2 minutes + 10 g tomato sauce Receives: Behavioral: (Components of) pasta meal |
| Carrot soft + sauce | Active comparator | 50 g diced carrot cooked for 20 minutes + 10 g tomato sauce Receives: Behavioral: (Components of) pasta meal |
| Penne hard + carrot hard + sauce | Active comparator | 20 g penne cooked for 7 minutes + 50 g diced carrot cooked for 2 minutes + 20 g tomato sauce Receives: Behavioral: (Components of) pasta meal |
| Penne hard + carrot soft + sauce | Active comparator | 20 g penne cooked for 7 minutes + 50 g diced carrot cooked for 20 minutes + 20 g tomato sauce Receives: Behavioral: (Components of) pasta meal |
| Penne soft + carrot hard + sauce | Active comparator | 20 g penne cooked for 20 minutes + 50 g diced carrot cooked for 2 minutes + 20 g tomato sauce Receives: Behavioral: (Components of) pasta meal |
| Penne soft + carrot soft + sauce | Active comparator | 20 g penne cooked for 20 minutes + 50 g diced carrot cooked for 20 minutes + 20 g tomato sauce Receives: Behavioral: (Components of) pasta meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating rate (g/min)
Amount of the sample divided by the consumption time of the sample, measured with video recording.
Measured: 1 sample, up to 30 minutes
Secondary outcomes (15)
Meal duration (min)
Time to consume one sample, measured with video recording.
Measured: 1 sample, up to 30 minutes
Bite duration (min)
Measured with video recording.
Measured: 1 sample, up to 30 minutes
Number of bites
Measured with video recording.
Measured: 1 sample, up to 30 minutes
Number of chews
Measured with video recording.
Measured: 1 sample, up to 30 minutes
Average bite size (g)
Measured with video recording.
Measured: 1 sample, up to 30 minutes
Chews per bite
Measured with video recording.
Measured: 1 sample, up to 30 minutes
Oro-sensory exposure time (min)
Measured with video recording.
Measured: 1 sample, up to 30 minutes
Liking flavour
Measured using a 100-mm visual analogue scale (VAS) ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line
Measured: 1 sample, up to 30 minutes
Liking texture
Measured using a 100-mm visual analogue scale (VAS) ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line
Measured: 1 sample, up to 30 minutes
Liking overall
Measured using a 100-mm visual analogue scale (VAS) ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line
Measured: 1 sample, up to 30 minutes
Sweetness
Measured using a 100-mm visual analogue scale (VAS) ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line
Measured: 1 sample, up to 30 minutes
Saltiness
Measured using a 100-mm visual analogue scale (VAS) ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line
Measured: 1 sample, up to 30 minutes
Sourness
Measured using a 100-mm visual analogue scale (VAS) ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line
Measured: 1 sample, up to 30 minutes
Hardness
Measured using a 100-mm visual analogue scale (VAS) ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line
Measured: 1 sample, up to 30 minutes
Chewiness
Measured using a 100-mm visual analogue scale (VAS) ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line
Measured: 1 sample, up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start14 Sep 2021
- Primary completion9 Dec 2021
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants receive twelve pasta samples differing in the hardness of carrots and penne, and the addition of sauce
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lise AJ Heuven, MSc, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019872
- Sponsor's protocol ID
- SEC WUR 2021
- Acronym
- ESPA
- Status last verified
- Dec 2021
- First submitted
- 19 Jul 2021
- Last updated
- 13 Dec 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 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Al Dente or Well Done? The Eating Rate of a Pasta Meal Modified by Texture
- ClinicalTrials.gov ID
- NCT05019872
- Acronym / sponsor ID
- ESPA / SEC WUR 2021
- Conditions
- Eating Behavior
- Keywords
- Eating rate, Pasta, Oral Processing, Eating Behaviour, Texture, Hardness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 25 Aug 2021 (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.
Rationale: The world-wide rising obesity rates are a major health problem. Therefore, people should moderate food intake. A lower eating rate will decrease the energy intake. The eating rate of foods can be modified by changing the texture without affecting their acceptability. Harder, chunkier, more viscous, and more voluminous foods will decrease the eating rate and thus energy intake. However, the impact of texture on oral processing has mostly been studied as a model or single food system, whereas a diet consists of many different food products often consumed in combination. Little has been researched on the effect of food texture on eating rate within the context of realistic meals. It is not known if the eating rate of a meal is determined by the eating rate component with the lowest eating rate or if there is an additive effect of the eating rates of all components of the meal.
Objective: The aim of the ESPA study is to determine how the eating rate of a pasta meal can be changed by manipulating the hardness of the ingredients and to investigate if the eating rate of a meal is determined by the eating rate of the component with the lowest eating rate or if there is an additive effect of the eating rates of all components of the meal.
Study design: The study is a randomized crossover trial. All participants receive all pasta samples.
Study population: Healthy adults (n=50) between 18-55 years old with European nationality, and a BMI between 18.5-30 kg/m2.
Intervention: Participants will attend three test sessions during lunch in which in total twelve pasta samples will be consumed. The pasta samples will consists of individual or combined pasta noodles, vegetables, and sauce differing in hardness. The order of the samples will be randomized. After the consumption of the test samples, the participants will rate their appetite and the sensory characteristics of the samples. During the test sessions, participants will be video recorded to determine their eating behavior.
Main study parameters/endpoints: The main study outcome is the eating rate (g/min). Secondary outcomes are the oral processing characteristics assessed with the video recordings (meal duration [min], bite duration [min], number of bites, number of chews, average bite size [g], average amount of chews per bite, and oral sensory exposure time [min]) and sensory characteristics rated on a visual analogue scale (liking [flavor, texture, and overall], flavor intensity, sweetness, saltiness, sourness, hardness, and chewiness).
Detailed description
The study has a randomized crossover design with three test sessions. All participants receive twelve pasta samples (four per test session) and are their own control (within subject effects).
Participants attend three test sessions during which they eat four pasta samples. The pasta samples will have a fixed amount and differ in pasta noodle and vegetable hardness. Eight pasta samples will consist out of only penne or carrots with or without sauce. Four pasta samples will consist out of penne, carrots, and sauce. The sample order will be randomized, but in each test session only one or two of sample 9 to 12 will be served. The samples will be served on a plate together with a fork.
Procedure of the study:
Throughout study period :
- No use of drugs
- Medication use + illness should be reported
Evening preceding test day:
- Not allowed to eat or drink after 22.00 except for water
Morning of test day:
- Do not perform intensive exercise
- Eat the same breakfast at the same time each test day
- If wanted, eat the same morning snack at the same time each test day
- Not allowed to eat or drink two hours prior the study session except for water
- Have a negative corona test
Lunch
- Give instructions (eat as you normally would do, eat the whole sample without taking breaks or sips of water in between, you can take a new bite before you swallowed the previous one)
- Seated at sensory booth with fork, knife, spoon, 200 mL of water and three pieces of a plain cracker
- Question about food consumption that morning
- Appetite questionnaire
- Eat the pasta sample (one of twelve conditions) while recording eating behavior
- Sensory questionnaire
- Appetite questionnaire
- Taste neutralization by waiting for two minutes, taking sip of water and bite of cracker
- Repeat * ... * until four pasta samples are consumed
- Appetite questionnaire
Participants will be recruited from Wageningen and surroundings using an e-mailing list, social media, and flyers. Healthy (self-report), normal weight (18.5-30 kg/m2) men and women between 18-55 years old will be included. Participants need to have European nationality, and have to be able to understand and speak English (self-report), because of the sensory questionnaire and appetite questionnaire which will be in English and have difficult direct translations to Dutch. As 90% of the people that show interest in the study are university students this should not be a problem. The BMI range is based on the average BMI in the Netherlands, which is 25 kg/m2 but around 50% of the Dutch population is overweight. To be able to include sufficient subjects it was therefore chosen to widen the BMI range and include people up to a BMI of 30 kg/m2. Due to the within subject design this will not influence the outcome of the study, but results will be more generalizable to people with an average weight.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 12
- Model description
- All participants receive twelve pasta samples differing in the hardness of carrots and penne, and the addition of sauce
| Arm | Type | Receives |
|---|---|---|
| Penne hard | Active comparator | Behavioral: (Components of) pasta meal20 g penne cooked for 7 minutes |
| Penne soft | Active comparator | Behavioral: (Components of) pasta meal20 g penne cooked for 20 minutes |
| Carrot hard | Active comparator | Behavioral: (Components of) pasta meal50 g diced carrot cooked for 2 minutes |
| Carrot soft | Active comparator | Behavioral: (Components of) pasta meal50 g diced carrot cooked for 20 minutes |
| Penne hard + sauce | Active comparator | Behavioral: (Components of) pasta meal20 g penne cooked for 7 minutes + 10 g tomato sauce |
| Penne soft + sauce | Active comparator | Behavioral: (Components of) pasta meal20 g penne cooked for 20 minutes + 10 g tomato sauce |
| Carrot hard + sauce | Active comparator | Behavioral: (Components of) pasta meal50 g diced carrot cooked for 2 minutes + 10 g tomato sauce |
| Carrot soft + sauce | Active comparator | Behavioral: (Components of) pasta meal50 g diced carrot cooked for 20 minutes + 10 g tomato sauce |
| Penne hard + carrot hard + sauce | Active comparator | Behavioral: (Components of) pasta meal20 g penne cooked for 7 minutes + 50 g diced carrot cooked for 2 minutes + 20 g tomato sauce |
| Penne hard + carrot soft + sauce | Active comparator | Behavioral: (Components of) pasta meal20 g penne cooked for 7 minutes + 50 g diced carrot cooked for 20 minutes + 20 g tomato sauce |
| Penne soft + carrot hard + sauce | Active comparator | Behavioral: (Components of) pasta meal20 g penne cooked for 20 minutes + 50 g diced carrot cooked for 2 minutes + 20 g tomato sauce |
| Penne soft + carrot soft + sauce | Active comparator | Behavioral: (Components of) pasta meal20 g penne cooked for 20 minutes + 50 g diced carrot cooked for 20 minutes + 20 g tomato sauce |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Between 18-55 years old at the day of inclusion
- European nationality
- Able to understand and speak English fluently or without difficulty (self-report)
- BMI 18.5-30 kg/m2 (self-report)
- Good general health and appetite (self-report)
Key exclusion criteria (16 listed)
- Pregnant or lactating women
- Smoking
- Braces (not including a dental wire) or oral piercing
- Difficulties with swallowing, chewing and/or eating in general
- Suffering from an endocrine or eating disorder, gastrointestinal illness or illness of the thyroid gland, respiratory disease, or diabetes
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 |
|---|---|---|
| (Components of) pasta mealSamples will be provided one by one in cups labeled with an unique code. | Behavioural | Carrot hard, Carrot hard + sauce, Carrot soft, Carrot soft + sauce, Penne hard, Penne hard + carrot hard + sauce, Penne hard + carrot soft + sauce, Penne hard + sauce, Penne soft, Penne soft + carrot hard + sauce, Penne soft + carrot soft + sauce, Penne soft + sauce |
Primary outcome
Eating rate (g/min)
Time frame: 1 sample, up to 30 minutes
Amount of the sample divided by the consumption time of the sample, measured with video recording.
15 secondary outcomes
Meal duration (min)
Time frame: 1 sample, up to 30 minutes
Bite duration (min)
Time frame: 1 sample, up to 30 minutes
Number of bites
Time frame: 1 sample, up to 30 minutes
Number of chews
Time frame: 1 sample, up to 30 minutes
Average bite size (g)
Time frame: 1 sample, up to 30 minutes
Chews per bite
Time frame: 1 sample, up to 30 minutes
Oro-sensory exposure time (min)
Time frame: 1 sample, up to 30 minutes
Liking flavour
Time frame: 1 sample, up to 30 minutes
Liking texture
Time frame: 1 sample, up to 30 minutes
Liking overall
Time frame: 1 sample, up to 30 minutes
Sweetness
Time frame: 1 sample, up to 30 minutes
Saltiness
Time frame: 1 sample, up to 30 minutes
Sourness
Time frame: 1 sample, up to 30 minutes
Hardness
Time frame: 1 sample, up to 30 minutes
Chewiness
Time frame: 1 sample, up to 30 minutes
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 13 Dec 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.
Lise AJ Heuven, MSc principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (Components of) pasta meal in people with Eating Behavior, run by Wageningen University at 1 site in Netherlands.
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 6 inclusion and 16 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 13 Dec 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 Netherlands. 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 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?
Eating rate (g/min) (time frame: 1 sample, up to 30 minutes). 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 13 Dec 2021.