Appetitive BehaviorLubSatNCT04868461
Effect of Oral Lubrication on Appetite, Food Intake and Salivary Biomarkers in Protein Beverages
A study testing Unheated Whey Protein (UWP) beverage, Heated Whey Protein (HWP) beverage and Casein (Cas) beverage in people with Appetitive Behavior, run by University of Leeds at 1 site in United Kingdom.
Trial summary
The main aim of this study is to elucidate the influence of protein beverages differing in their lubrication properties (low/medium/high lubricating) and control (water) on satiety and satiation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior
- What is being tested?
- Unheated Whey Protein (UWP) beverage, Heated Whey Protein (HWP) beverage and Casein (Cas) beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Apr 2021to 30 Apr 2022
- 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
- Adults aged 18-55 years old
- With a BMI between 18.5 - 27.99 kg/m²)
- Generally healthy
Who cannot join
- have any blood borne disease;
- have type-1 or type-2 diabetes;
- have liver and kidney disease;
- have past history of gastrointestinal surgery;
- are a smoker;
- have oral infections/ diseases;
Show all 16Show fewer
- have chronic or acute health condition that may affect ability to sense, eat, digest, absorb or excrete food;
- have a sensitive stomach (Irritable Bowel Stomach);
- are currently using prescribed or non-prescribed medication;
- are pregnant or lactating;
- are suffering from an illness, feeling unwell, having fever, or cold or cough;
- history of food allergy or intolerance;
- are on any special diet or are taking protein and/or fibre supplements;
- cannot tolerate protein beverages;
- present any COVID related symptoms (high temperature, a new continuous cough, a loss or change to your smell or taste);
- if you are self-isolating or if you leave with someone self-isolating or presenting COVID related symptoms.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leeds
Leeds, West Yorkshire, LS2 9JT
About this study
Official title: Effects of Protein Beverages Differing in Their Lubricating Properties on Appetite Control, Subsequent Food Intake and Salivary Biomarkers
The main aim of this study is to elucidate the influence of protein beverages differing in their lubrication properties (low/medium/high lubricating) and control (water) on satiety and satiation.
Read the detailed description
The researchers propose an acute, randomized cross-over study that compares three types of protein beverages differing in their lubricating properties, i.e. one with low lubricating properties made using sodium caseinate, one with medium lubricating properties made by whey protein, and the third one with high lubricating properties made by heated whey protein. All three beverages contain added banana flavour and non-nutritive sweetener. Water acts as a control and has the same flavour and sweetness to match those of the protein beverages.
Participants are asked to come to the laboratory on four occasions. Before participating, each participant is screened for eligibility criteria using an online health screening questionnaire and Three Factors Eating Questionnaire. Participants are offered one of the four treatments (water or either of the three protein beverages), the order of which is randomized and counterbalanced.
Participants are instructed to fast for 11 hours and to restrict from drinking alcohol for 24 hours before each session. Each session lasts 1.5 hours (8.40 am until 10.10 pm). In the first session, weight and height are measured. Participants then provide baseline (- 5 min) appetite ratings on a 100 mm visual analogue scale (VAS). After that they are given the preload - either protein beverages differing in their lubricating properties or water. Then, participants are asked to rate their appetite on a 100-mm VAS every 10 minutes for the next 30 minutes. Ad libitum food is offered as breakfast after 30 min after ingesting the preload and the last VAS is taken. Saliva is taken three times during each session before preload, after preload consumption and before ad libitum breakfast.
- Conditions
- Appetitive Behavior
- Being tested
- Unheated Whey Protein (UWP) beverage, Heated Whey Protein (HWP) beverage, Casein (Cas) beverage, Water
- Keywords
- Lubrication, protein, satiety, appetite control, food intake, salivary biomarkers
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unheated Whey Protein (UWP) beverageDietary supplement
The preload is made from whey protein powder. The energy load of the preload is 119.7 kcal and has banana flavor and sweetener.
Heated Whey Protein (HWP) beverageDietary supplement
The preload is made from whey protein powder of 95% and it is heated for a certain amount of time. The energy load of the preload is 119.7 kcal and has banana flavor and sweetener.
Casein (Cas) beverageDietary supplement
The preload is made from casein powder. The energy load of the preload is 105 kcal and has banana flavor and sweetener.
WaterDietary supplement
The preload is water acting as a control and contain the same banana flavor and sweetener to match the other three intervention - protein beverages.
| Study group | Role | What they receive |
|---|---|---|
| Unheated whey protein (UWP) | Active comparator | Participants are given a preload of 200 mL of unheated whey protein (UWP) in the morning, on a fasting state. After 30 minutes after the preload, participants are given ad libitum breakfast. They are asked to eat "as much or as little as they want, until they feel comfortably full". Receives: Dietary Supplement: Unheated Whey Protein (UWP) beverage |
| Heated whey protein (HWP) | Active comparator | Participants are given a preload of 200 mL of heated whey protein (HWP) in the morning, on a fasting state. After 30 minutes after the preload, participants are given ad libitum breakfast. They are asked to eat "as much or as little as they want, until they feel comfortably full". Receives: Dietary Supplement: Heated Whey Protein (HWP) beverage |
| Casein (Cas) | Active comparator | Participants are given a preload of 200 mL of Casein (Cas) in the morning, on a fasting state. After 30 minutes after the preload, participants are given ad libitum breakfast. They are asked to eat "as much or as little as they want, until they feel comfortably full". Receives: Dietary Supplement: Casein (Cas) beverage |
| Water | Placebo comparator | The water has the same banana flavor and sweetness to match the protein beverages. Participants receive the same amount of water like protein beverages - 200mL. Receives: Dietary Supplement: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline level and change in hunger ratings
A questionnaire assessing perceived hunger is completed at specific times points throughout each of the 1.5-h testing days. The questionnaire is a 100 mm VAS representing a horizontal line rating scale for each response. It asks: "How hungry do you feel right now?" with anchors of "not all" to "extremely." The range is 0 mm (min hunger) and 100 is (max hunger).
Measured: -5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.
Baseline level and change in fullness ratings
A questionnaire assessing perceived fullness is completed at specific times points throughout each of the 1.5-h testing days. The questionnaire is a 100 mm VAS representing a horizontal line rating scale for each response. It asks: "How full do you feel right now?" with anchors of "not all" to "extremely." The range is 0 mm (min fullness) and 100 is (max fullness).
Measured: -5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.
Baseline level and change in desire to eat ratings
A questionnaire assessing perceived desire to eat is completed at specific times points throughout each of the 1.5-h testing days. The questionnaire is a 100 mm VAS representing a horizontal line rating scale for each response. It asks: "How strong is your desire to eat right now?" with anchors of "not all" to "extremely." The range is 0 mm (min desire to eat) and 100 is (max desire to eat).
Measured: -5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.
Baseline level and change in prospective food consumption ratings
A questionnaire assessing perceived prospective food consumption is completed at specific time points throughout each of the 1.5-h testing days. The questionnaire is a 100 mm VAS representing a horizontal line rating scale for each response. It asks: "How much food do you think you could eat right now?" with anchors of "not all" to "extremely." The range is 0 mm (min prospective food consumption) and 100 is (max prospective food consumption.
Measured: -5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.
Baseline level and change in thirst ratings
A questionnaire assessing perceived thirst is completed at specific time points throughout each of the 1.5-h testing days. The questionnaire is a 100 mm VAS representing a horizontal line rating scale for each response. It asks: "How thirsty do you feel right now?" with anchors of "not all" to "extremely." The range is 0 mm (min thirst) and 100 is (max thirst).
Measured: -5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.
Baseline level and change in breakfast energy intake
The participants are provided with an ad libitum breakfast of cereals and milk, tea/coffee (at participant choice) and water. The amount of breakfast is provided (in grams) and is weighted prior to consumption and any remains are re-weighted after consumption. Energy consumed will be calculated. Participants are given 15 minutes for consuming the breakfast.
Measured: -5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.
Baseline level and change in salivary protein
Saliva is collected on three time points on each visit. Salivary protein will be analyzed to determine the relationship between these components that affect oral lubrication and satiety and satiation.
Measured: -5 minutes, 20 minutes, 50 minutes
Baseline level and change in salivary amylase
Saliva is collected on three time points on each visit. Salivary amylase will be analyzed to determine the relationship between these components that affect oral lubrication and satiety and satiation.
Measured: -5 minutes, 20 minutes, 50 minutes
Baseline level and change in salivary mucin
Saliva is collected on three time points on each visit. Salivary mucin will be analyzed to determine the relationship between these components that affect oral lubrication and satiety and satiation.
Measured: -5 minutes, 20 minutes, 50 minutes,
Secondary outcomes (1)
Liking and wanting of the preload using Visual Analogue Scale (VAS)
Liking and wanting of both the protein beverages and water are assessed through a 100 mm VAS scale where 0 means "not at all" and 100 means "extremely". Within the liking the ratings are taking on following attributes: the texture, flavor, sweetness and overall liking/pleasantness. The questions asked are: "How much did you like the texture of the product you have just consumed?", "How much did you like the flavor of the product you have just consumed?", How intense was the sweet taste of the product you have just consumed?", "How pleasant was the product you have just consumed? "with anchors from "not at all" to "extremely". And for the wanting assessment the question is: "How much did you want to consume the product you have just had?" with anchors from "not at all" to "extremely".
Measured: Immediately after eating the preload.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start13 Apr 2021
- Primary completion31 Mar 2022
- Study completion30 Apr 2022
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 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
- Tightly controlled cross-over study design with four arms.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anwesha Sarkar, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868461
- Sponsor's protocol ID
- LUBSAT (18-049) - Protein
- Other IDs
- 757993
- Acronym
- LubSat
- Status last verified
- Nov 2022
- First submitted
- 22 Apr 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stribitcaia E, Gibbons C, Finlayson G, You KM, Araiza-Calahorra A, Hafiz MS, Ellis LR, Boesch C, Sier JH, Blundell J, Sarkar A. Effect of in vitro food oral coating and lubricity on satiety: A randomized controlled trial using milk protein beverages. Physiol Behav. 2024 Dec 1;287:114690. doi: 10.1016/j.physbeh.2024.114690. Epub 2024 Sep 7.
PubMed 39251153
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Protein Beverages Differing in Their Lubricating Properties on Appetite Control, Subsequent Food Intake and Salivary Biomarkers
- ClinicalTrials.gov ID
- NCT04868461
- Acronym / sponsor ID
- LubSat / LUBSAT (18-049) - Protein
- Conditions
- Appetitive Behavior
- Keywords
- Lubrication, protein, satiety, appetite control, food intake, salivary biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 3 May 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.
The main aim of this study is to elucidate the influence of protein beverages differing in their lubrication properties (low/medium/high lubricating) and control (water) on satiety and satiation.
Detailed description
The researchers propose an acute, randomized cross-over study that compares three types of protein beverages differing in their lubricating properties, i.e. one with low lubricating properties made using sodium caseinate, one with medium lubricating properties made by whey protein, and the third one with high lubricating properties made by heated whey protein. All three beverages contain added banana flavour and non-nutritive sweetener. Water acts as a control and has the same flavour and sweetness to match those of the protein beverages.
Participants are asked to come to the laboratory on four occasions. Before participating, each participant is screened for eligibility criteria using an online health screening questionnaire and Three Factors Eating Questionnaire. Participants are offered one of the four treatments (water or either of the three protein beverages), the order of which is randomized and counterbalanced.
Participants are instructed to fast for 11 hours and to restrict from drinking alcohol for 24 hours before each session. Each session lasts 1.5 hours (8.40 am until 10.10 pm). In the first session, weight and height are measured. Participants then provide baseline (- 5 min) appetite ratings on a 100 mm visual analogue scale (VAS). After that they are given the preload - either protein beverages differing in their lubricating properties or water. Then, participants are asked to rate their appetite on a 100-mm VAS every 10 minutes for the next 30 minutes. Ad libitum food is offered as breakfast after 30 min after ingesting the preload and the last VAS is taken. Saliva is taken three times during each session before preload, after preload consumption and before ad libitum breakfast.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Tightly controlled cross-over study design with four arms.
| Arm | Type | Receives |
|---|---|---|
| Unheated whey protein (UWP) | Active comparator | Dietary Supplement: Unheated Whey Protein (UWP) beverageParticipants are given a preload of 200 mL of unheated whey protein (UWP) in the morning, on a fasting state. After 30 minutes after the preload, participants are given ad libitum breakfast. They are asked to eat "as much or as little as they want, until they feel comfortably full". |
| Heated whey protein (HWP) | Active comparator | Dietary Supplement: Heated Whey Protein (HWP) beverageParticipants are given a preload of 200 mL of heated whey protein (HWP) in the morning, on a fasting state. After 30 minutes after the preload, participants are given ad libitum breakfast. They are asked to eat "as much or as little as they want, until they feel comfortably full". |
| Casein (Cas) | Active comparator | Dietary Supplement: Casein (Cas) beverageParticipants are given a preload of 200 mL of Casein (Cas) in the morning, on a fasting state. After 30 minutes after the preload, participants are given ad libitum breakfast. They are asked to eat "as much or as little as they want, until they feel comfortably full". |
| Water | Placebo comparator | Dietary Supplement: WaterThe water has the same banana flavor and sweetness to match the protein beverages. Participants receive the same amount of water like protein beverages - 200mL. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged 18-55 years old
- With a BMI between 18.5 - 27.99 kg/m²)
- Generally healthy
Key exclusion criteria (16 listed)
- have any blood borne disease;
- have type-1 or type-2 diabetes;
- have liver and kidney disease;
- have past history of gastrointestinal surgery;
- are a smoker;
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 |
|---|---|---|
| Unheated Whey Protein (UWP) beverageThe preload is made from whey protein powder. The energy load of the preload is 119.7 kcal and has banana flavor and sweetener. | Dietary supplement | Unheated whey protein (UWP) |
| Heated Whey Protein (HWP) beverageThe preload is made from whey protein powder of 95% and it is heated for a certain amount of time. The energy load of the preload is 119.7 kcal and has banana flavor and sweetener. | Dietary supplement | Heated whey protein (HWP) |
| Casein (Cas) beverageThe preload is made from casein powder. The energy load of the preload is 105 kcal and has banana flavor and sweetener. | Dietary supplement | Casein (Cas) |
| WaterThe preload is water acting as a control and contain the same banana flavor and sweetener to match the other three intervention - protein beverages. | Dietary supplement | Water |
Primary outcome
Baseline level and change in hunger ratings
Time frame: -5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.
A questionnaire assessing perceived hunger is completed at specific times points throughout each of the 1.5-h testing days. The questionnaire is a 100 mm VAS representing a horizontal line rating scale for each response. It asks: "How hungry do you feel right now?" with anchors of "not all" to "extremely." The range is 0 mm (min hunger) and 100 is (max hunger).
Baseline level and change in fullness ratings
Time frame: -5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.
A questionnaire assessing perceived fullness is completed at specific times points throughout each of the 1.5-h testing days. The questionnaire is a 100 mm VAS representing a horizontal line rating scale for each response. It asks: "How full do you feel right now?" with anchors of "not all" to "extremely." The range is 0 mm (min fullness) and 100 is (max fullness).
Baseline level and change in desire to eat ratings
Time frame: -5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.
A questionnaire assessing perceived desire to eat is completed at specific times points throughout each of the 1.5-h testing days. The questionnaire is a 100 mm VAS representing a horizontal line rating scale for each response. It asks: "How strong is your desire to eat right now?" with anchors of "not all" to "extremely." The range is 0 mm (min desire to eat) and 100 is (max desire to eat).
Baseline level and change in prospective food consumption ratings
Time frame: -5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.
A questionnaire assessing perceived prospective food consumption is completed at specific time points throughout each of the 1.5-h testing days. The questionnaire is a 100 mm VAS representing a horizontal line rating scale for each response. It asks: "How much food do you think you could eat right now?" with anchors of "not all" to "extremely." The range is 0 mm (min prospective food consumption) and 100 is (max prospective food consumption.
Baseline level and change in thirst ratings
Time frame: -5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.
A questionnaire assessing perceived thirst is completed at specific time points throughout each of the 1.5-h testing days. The questionnaire is a 100 mm VAS representing a horizontal line rating scale for each response. It asks: "How thirsty do you feel right now?" with anchors of "not all" to "extremely." The range is 0 mm (min thirst) and 100 is (max thirst).
Baseline level and change in breakfast energy intake
Time frame: -5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.
The participants are provided with an ad libitum breakfast of cereals and milk, tea/coffee (at participant choice) and water. The amount of breakfast is provided (in grams) and is weighted prior to consumption and any remains are re-weighted after consumption. Energy consumed will be calculated. Participants are given 15 minutes for consuming the breakfast.
Baseline level and change in salivary protein
Time frame: -5 minutes, 20 minutes, 50 minutes
Saliva is collected on three time points on each visit. Salivary protein will be analyzed to determine the relationship between these components that affect oral lubrication and satiety and satiation.
Baseline level and change in salivary amylase
Time frame: -5 minutes, 20 minutes, 50 minutes
Saliva is collected on three time points on each visit. Salivary amylase will be analyzed to determine the relationship between these components that affect oral lubrication and satiety and satiation.
Baseline level and change in salivary mucin
Time frame: -5 minutes, 20 minutes, 50 minutes,
Saliva is collected on three time points on each visit. Salivary mucin will be analyzed to determine the relationship between these components that affect oral lubrication and satiety and satiation.
1 secondary outcome
Liking and wanting of the preload using Visual Analogue Scale (VAS)
Time frame: Immediately after eating the preload.
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 2 Nov 2022.
- Derived from this study: PubMed 39251153Stribitcaia E, Gibbons C, Finlayson G, You KM, Araiza-Calahorra A, Hafiz MS, Ellis LR, Boesch C, Sier JH, Blundell J, Sarkar A. Effect of in vitro food oral coating and lubricity on satiety: A randomized controlled trial using milk protein beverages. Physiol Behav. 2024 Dec 1;287:114690. doi: 10.1016/j.physbeh.2024.114690. Epub 2024 Sep 7.
- Individual participant dataSharing planned: No
Related trials for Appetitive Behavior
Active, not recruitingObservational study
Appetitive Conditioning in Anorexia Nervosa
Anorexia Nervosa
Recruiting
Behavioral Approach for Latinas Addressing Nutrition, Cravings, and Eating Patterns to Prevent Type 2 Diabetes
Prediabetes, Obesity (Body Mass Index >30 kg/m2)
Recruiting
Validation of a Novel Cerebellar-striatal Satiety Circuit in Humans
Appetitive Behavior, Obesity
Recruiting
Exercise, Brain Activity, and Weight Maintenance
Obesity, Weight Gain
RecruitingPhase 4
Metabolic and Behavioural Effects of CONTRAVE as Potential Mechanisms of Weight Loss in Adults With Obesity
Obesity, Weight Loss
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 Unheated Whey Protein (UWP) beverage, Heated Whey Protein (HWP) beverage and Casein (Cas) beverage in people with Appetitive Behavior, run by University of Leeds at 1 site in United Kingdom.
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 3 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 2 Nov 2022. 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 Kingdom. 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?
Baseline level and change in hunger ratings (time frame: -5 minutes, 0 minute, 10 minutes, 20 minutes, 30 minutes, 50 minutes.). The study lists 9 primary outcomes in all. 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 NCT04868461, 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 2 Nov 2022.