Abdominal ObesityCHICKPEPNCT05149092
Effects of Chicken Protein Hydrolysate (CPH) Supplementation in People With High Waist Circumference
A study testing Chicken protein hydrolysate supplement in people with Abdominal Obesity, run by University of Bergen at 1 site in Norway.
Trial summary
In this randomized, placebo controlled, double blind trial, effects of relatively high doses of chicken protein hydrolysate (CPH) or casein hydrolysate (placebo) supplementation will be investigate in healthy persons with abdominal obesity. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity
- What is being tested?
- Chicken protein hydrolysate supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteNorway
- Study dates
- 18 Jan 2021to 30 Apr 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female and male subjects at least 20 years old understanding Norwegian oral and written information
- Waist circumference of:
- Men > 95 cm
- Women > 81 cm
Who cannot join
- Pregnancy
- Having used high-dose omega-3 PUFA supplements (>2 g/day) 28 days' prior to randomization
- Alcohol or drug abuse or any conditions associated with poor compliance
- Scheduled hospitalization during the course of the study that could compromise the study
- Major diseases or infections including chronic diseases
- Known or suspected sensitivity or allergic reactions to the IMP or excipients
- Presence of other major medical or psychiatric illness that would affect the ability to participate in the study or put the subject at increased risk
- Intake of statins. If needed to obtain the recruitment goals, we will accept people using a low dose of statin. Simvastatin 10 mg or Pravastatin 10-20 mg will be accepted, but not higher doses or the drugs Lipitor/Atorvastatin and Crestor/Rosuvastatin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double Blind, Placebo Controlled Study to Investigate the Effect of Chicken Protein Hydrolysates (CPH) in Persons With High Waist Circumference
In this randomized, placebo controlled, double blind trial, effects of relatively high doses of chicken protein hydrolysate (CPH) or casein hydrolysate (placebo) supplementation will be investigate in healthy persons with abdominal obesity. The 12-week study examines potential effects on body weight, abdominal obesity, body composition, plasma parameters of metabolic health including lipids, inflammatory parameters, redox state and microbiota biomarkers.
Read the detailed description
Small peptides in the range of 2 - 12 amino acids are believed to cross the intestinal wall undigested and enter the circulation where they can have a range of activities based on their amino acid composition and structure. Natural peptides isolated from a number of food proteins, including plants and marine organisms, are shown to have antioxidant effects in in vitro tests, and anti-hypertensive effects in mice through inhibition of the angiotensin-converting-enzyme (ACE). Protein hydrolysates from both animal- and plant-based sources will consist of a mixture of potentially bioactive peptides that can have specific effects based on their composition. Studies have shown that egg- and soy-derived hydrolysates have anti-diabetic and anti-obesity properties in rodents. Pre-clinical studies in mice have demonstrated potent plasma cytokine lowering abilities and atherosclerosis-prevention by chicken protein hydrolysate (CPH) diets, as well as effects on plasma cholesterol level, cytokines and lipid metabolism, including mitochondrial function. In addition, an isolated peptide fraction from chicken inhibits the dipeptyl peptidase IV, and thus has the potential to restore glucose homeostasis in type 2 diabetics.
The hydrolysate supplements used in this study are obtained from rest raw materials (RRM) from mechanical deboning of chicken meat (Food Grade, Nortura AS Hærland, Norway). Freshly minced chicken RRM has been treated with enzymes optimized to generate bioactive hydrolysates. The supplement is given in a dose of 18 g protein per day, corresponding to the protein content of a standard meal, and similar to doses recommended in protein shake supplements.
Around 60 males and females age >20 years with abdominal obesity participate, recruited primarily through social media advertisements (Facebook) limited to a 12 km radius around the city center of Bergen. Participants provided written informed consent, and were screened via self-reporting in an online form in EasyTrial hosted by the Research Unit for Clinical Trials at the University of Bergen. Data collection by the study staff at baseline verifies inclusion and exclusion criteria and participant eligibility prior to randomization. The potential participants are informed about practical details at a digital or physical meeting 1-2 weeks prior to baseline.
Groups of participants (40-60% males/females) are block randomized to the two treatments (CPH or placebo casein supplementation) using randomly selected block sizes, and stratified according to sex.
The participants are given a container with the powder sufficient for the entire 12-week study period, and a spoon to measure the intake at breakfast (6 g), lunch (6 g) and supper (6 g), or morning (9 g) and evening (9 g) according to individual preference. The patients will mix the powder products in water or mineral water.
- Conditions
- Abdominal Obesity
- Being tested
- Chicken protein hydrolysate supplement, Placebo
- Keywords
- Cardiovascular disease risk, Protein supplementation, Metabolic health
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chicken protein hydrolysate supplementDietary supplement
Also called CPH
Daily oral self-administration of 18 g of supplement dissolved in water/mineral water, spread over 2-3 occasions
PlaceboDietary supplement
Also called Casein
Daily oral self-administration of 18 g of supplement dissolved in water/mineral water, spread over 2-3 occasions
| Study group | Role | What they receive |
|---|---|---|
| Placebo (casein protein supplement) | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Chicken protein hydrolysate supplement | Active comparator | Not described Receives: Dietary Supplement: Chicken protein hydrolysate supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in waist circumference in the CPH group as compared to placebo/casein at week 12
Waist circumference will be measured using anthropometric tape over light clothing. For waist circumference, the minimum circumference between the iliac crest and the rib cage will be used.
Measured: At baseline visit and end visit (week 12)
Secondary outcomes (24)
Changes from baseline in glucagon-like peptide 1 (GLP-1, hormone involved in appetite and metabolism regulation) in the CPH group as compared to placebo/casein
Measured in plasma using immunological methods (ELISA). All plasma samples will be kept on ice directly after collection, and relevant inhibitors will be added.
Measured: At baseline visit and end visit (week 12)
Changes from baseline in gastric inhibitory polypeptide (GIP, hormone involved in metabolism regulation) in the CPH group as compared to placebo/casein
Measured in plasma using immunological methods (ELISA). All plasma samples will be kept on ice directly after collection, and relevant inhibitors will be added.
Measured: At baseline visit and end visit (week 12)
Changes from baseline in ghrelin (hormone involved in appetite regulation) in the CPH group as compared to placebo/casein
Measured in plasma using immunological methods (ELISA). All plasma samples will be kept on ice directly after collection, and relevant inhibitors will be added.
Measured: At baseline visit and end visit (week 12)
Changes from baseline in heart rate in the CPH group as compared to placebo/casein
The heart rate will be registered after 5 minutes of supine rest using a Schiller BP-200
Measured: At baseline visit and end visit (week 12)
Changes from baseline in blood pressure in the CPH group as compared to placebo/casein
The blood pressure will be registered after 5 minutes of supine rest using a blood pressure monitor.
Measured: At baseline visit and end visit (week 12)
Changes from baseline in waist/hip ratio in the CPH group as compared to placebo/casein
Waist and hip circumference will be measured using anthropometric tape over light clothing. For waist circumference, the minimum circumference between the iliac crest and the rib cage will be used. For hip circumference, the maximum measurement over the great trochanters will be used.
Measured: At baseline visit and end visit (week 12)
Changes from baseline in waist/height ratio in the CPH group as compared to placebo/casein
Height will be measured with a wall-mounted stadiometer. Waist circumference will be measured using anthropometric tape over light clothing. The minimum circumference between the iliac crest and the rib cage will be used.
Measured: At baseline visit and end visit (week 12)
Changes from baseline in the Quick1 surrogate marker forinsulin sensitivity in the CPH group as compared to placebo/casein
Glucose and insulin will be measured in serum by routine laboratories. Quick1 will be calculated by 1 / (log(fasting insulin μU/mL) + log(fasting glucose mg/dL)
Measured: At baseline visit and end visit (week 12)
Changes from baseline in serum glucose in the CPH group as compared to placebo/casein
Will be measured in serum by routine laboratories
Measured: At baseline visit and end visit (week 12)
Changes from baseline in serum insulin c-peptide in the CPH group as compared to placebo/casein
Will be measured in serum by routine laboratories
Measured: At baseline visit and end visit (week 12)
Changes from baseline in serum insulin in the CPH group as compared to placebo/casein
Will be measured in serum by routine laboratories
Measured: At baseline visit and end visit (week 12)
Changes from baseline in serum total cholesterol in the CPH group as compared to placebo/casein
Will be measured in serum by routine laboratories
Measured: At baseline visit and end visit (week 12)
Changes from baseline in serum triacylglycerol (TAG) in the CPH group as compared to placebo/casein
Will be measured in serum by routine laboratories
Measured: At baseline visit and end visit (week 12)
Change from baseline in serum non-esterified fatty acids (NEFA) in the CPH group as compared to placebo/casein
Will be measured in serum by routine laboratories
Measured: At baseline visit and end visit (week 12)
Change from baseline in serum non-HDL cholesterol in the CPH group as compared to placebo/casein
Will be measured in serum by routine laboratories
Measured: At baseline visit and end visit (week 12)
Change from baseline in serum CRP in the CPH group as compared to placebo/casein
Will be measured in serum by routine laboratories
Measured: At baseline visit and end visit (week 12)
Change from baseline in serum HDL cholesterol/LDL cholesterol size ratio in the CPH group as compared to placebo/casein
Lipoprotein profile will be analysed by exclusion gel chromatography.
Measured: At baseline visit and end visit (week 12)
Change from baseline in serum ceramides in the CPH group as compared to placebo/casein
The ceramides in plasma will be analysed by LC-MS.
Measured: At baseline visit and end visit (week 12)
Change from baseline in fat mass/fat-free mass ratio in the CPH group as compared to placebo/casein
Bioelectrical impedance measurement will be used for the assessment of body composition.
Measured: At baseline visit and end visit (week 12)
Changes in antioxidant capacity in the CPH group as compared to placebo/casein at week 12
Measured in plasma by a commercial kit (Sigma Aldrich, MAK187)
Measured: At baseline visit and end visit (week 12)
Changes in serum acetylcarnitine/palmitoylcarnitine ratio in the CPH group as compared to placebo/casein at week 12
Short-, medium-, and long-chain acylcarnitines, will be analysed in serum using LC/MS/MS.
Measured: At baseline visit and end visit (week 12)
Changes in serum octanoylcarnitine in the CPH group as compared to placebo/casein at week 12
Plasma choline, betaine, free carnitine and its precursors: trimethyllysine and γ-butyrobetaine, as well as short-, medium-, and long-chain acylcarnitines, will be analysed in serum using LC/MS/MS. Stable isotope dilution LC/MS/MS will be used for quantification of trimethylamine oxide (TMAO), dimethylglycine (DMG), choline and betaine. Plasma metabolites of the TCA cycle and amino acids-kynurenine-nicotinamide pathway will be measured by LC-MS.
Measured: At baseline visit and end visit (week 12)
Changes in serum TMAO (trimethylamine N-oxide) in the CPH group as compared to placebo/casein at week 12
Stable isotope dilution LC/MS/MS will be used for quantification of trimethylamine oxide (TMAO).
Measured: At baseline visit and end visit (week 12)
Changes from baseline in the serum anti-inflammatory fatty acid index in the CPH group as compared to placebo at Week 12.
Fatty acid composition will be analysed using GC/MS. The anti-inflammatory fatty acid index is calculated as ((C22:5n-3 + C22:6n-3 + C20:3n-6 + C20:5n-3)/C20:4n-6)*100
Measured: At baseline visit and end visit (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start18 Jan 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, Norilia AS
- Responsible party
- Sponsor
- Investigators
- Rolf K Berge, PhD, Study director, University of Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149092
- Sponsor's protocol ID
- CPH-Study
- Acronym
- CHICKPEP
- Status last verified
- Nov 2023
- First submitted
- 9 Mar 2021
- Last updated
- 29 Nov 2023
- 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Controlled Study to Investigate the Effect of Chicken Protein Hydrolysates (CPH) in Persons With High Waist Circumference
- ClinicalTrials.gov ID
- NCT05149092
- Acronym / sponsor ID
- CHICKPEP / CPH-Study
- Conditions
- Abdominal Obesity
- Keywords
- Cardiovascular disease risk, Protein supplementation, Metabolic health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, Norilia AS
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 8 Dec 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.
In this randomized, placebo controlled, double blind trial, effects of relatively high doses of chicken protein hydrolysate (CPH) or casein hydrolysate (placebo) supplementation will be investigate in healthy persons with abdominal obesity. The 12-week study examines potential effects on body weight, abdominal obesity, body composition, plasma parameters of metabolic health including lipids, inflammatory parameters, redox state and microbiota biomarkers.
Detailed description
Small peptides in the range of 2 - 12 amino acids are believed to cross the intestinal wall undigested and enter the circulation where they can have a range of activities based on their amino acid composition and structure. Natural peptides isolated from a number of food proteins, including plants and marine organisms, are shown to have antioxidant effects in in vitro tests, and anti-hypertensive effects in mice through inhibition of the angiotensin-converting-enzyme (ACE). Protein hydrolysates from both animal- and plant-based sources will consist of a mixture of potentially bioactive peptides that can have specific effects based on their composition. Studies have shown that egg- and soy-derived hydrolysates have anti-diabetic and anti-obesity properties in rodents. Pre-clinical studies in mice have demonstrated potent plasma cytokine lowering abilities and atherosclerosis-prevention by chicken protein hydrolysate (CPH) diets, as well as effects on plasma cholesterol level, cytokines and lipid metabolism, including mitochondrial function. In addition, an isolated peptide fraction from chicken inhibits the dipeptyl peptidase IV, and thus has the potential to restore glucose homeostasis in type 2 diabetics.
The hydrolysate supplements used in this study are obtained from rest raw materials (RRM) from mechanical deboning of chicken meat (Food Grade, Nortura AS Hærland, Norway). Freshly minced chicken RRM has been treated with enzymes optimized to generate bioactive hydrolysates. The supplement is given in a dose of 18 g protein per day, corresponding to the protein content of a standard meal, and similar to doses recommended in protein shake supplements.
Around 60 males and females age >20 years with abdominal obesity participate, recruited primarily through social media advertisements (Facebook) limited to a 12 km radius around the city center of Bergen. Participants provided written informed consent, and were screened via self-reporting in an online form in EasyTrial hosted by the Research Unit for Clinical Trials at the University of Bergen. Data collection by the study staff at baseline verifies inclusion and exclusion criteria and participant eligibility prior to randomization. The potential participants are informed about practical details at a digital or physical meeting 1-2 weeks prior to baseline.
Groups of participants (40-60% males/females) are block randomized to the two treatments (CPH or placebo casein supplementation) using randomly selected block sizes, and stratified according to sex.
The participants are given a container with the powder sufficient for the entire 12-week study period, and a spoon to measure the intake at breakfast (6 g), lunch (6 g) and supper (6 g), or morning (9 g) and evening (9 g) according to individual preference. The patients will mix the powder products in water or mineral water.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo (casein protein supplement) | Placebo comparator | Dietary Supplement: Placebo |
| Chicken protein hydrolysate supplement | Active comparator | Dietary Supplement: Chicken protein hydrolysate supplement |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female and male subjects at least 20 years old understanding Norwegian oral and written information
- Waist circumference of:
Key exclusion criteria (8 listed)
- Pregnancy
- Having used high-dose omega-3 PUFA supplements (>2 g/day) 28 days' prior to randomization
- Alcohol or drug abuse or any conditions associated with poor compliance
- Scheduled hospitalization during the course of the study that could compromise the study
- Major diseases or infections including chronic diseases
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 |
|---|---|---|
| Chicken protein hydrolysate supplementAlso: CPHDaily oral self-administration of 18 g of supplement dissolved in water/mineral water, spread over 2-3 occasions | Dietary supplement | Chicken protein hydrolysate supplement |
| PlaceboAlso: CaseinDaily oral self-administration of 18 g of supplement dissolved in water/mineral water, spread over 2-3 occasions | Dietary supplement | Placebo (casein protein supplement) |
Primary outcome
Changes from baseline in waist circumference in the CPH group as compared to placebo/casein at week 12
Time frame: At baseline visit and end visit (week 12)
Waist circumference will be measured using anthropometric tape over light clothing. For waist circumference, the minimum circumference between the iliac crest and the rib cage will be used.
24 secondary outcomes
Changes from baseline in glucagon-like peptide 1 (GLP-1, hormone involved in appetite and metabolism regulation) in the CPH group as compared to placebo/casein
Time frame: At baseline visit and end visit (week 12)
Changes from baseline in gastric inhibitory polypeptide (GIP, hormone involved in metabolism regulation) in the CPH group as compared to placebo/casein
Time frame: At baseline visit and end visit (week 12)
Changes from baseline in ghrelin (hormone involved in appetite regulation) in the CPH group as compared to placebo/casein
Time frame: At baseline visit and end visit (week 12)
Changes from baseline in heart rate in the CPH group as compared to placebo/casein
Time frame: At baseline visit and end visit (week 12)
Changes from baseline in blood pressure in the CPH group as compared to placebo/casein
Time frame: At baseline visit and end visit (week 12)
Changes from baseline in waist/hip ratio in the CPH group as compared to placebo/casein
Time frame: At baseline visit and end visit (week 12)
Changes from baseline in waist/height ratio in the CPH group as compared to placebo/casein
Time frame: At baseline visit and end visit (week 12)
Changes from baseline in the Quick1 surrogate marker forinsulin sensitivity in the CPH group as compared to placebo/casein
Time frame: At baseline visit and end visit (week 12)
Changes from baseline in serum glucose in the CPH group as compared to placebo/casein
Time frame: At baseline visit and end visit (week 12)
Changes from baseline in serum insulin c-peptide in the CPH group as compared to placebo/casein
Time frame: At baseline visit and end visit (week 12)
Changes from baseline in serum insulin in the CPH group as compared to placebo/casein
Time frame: At baseline visit and end visit (week 12)
Changes from baseline in serum total cholesterol in the CPH group as compared to placebo/casein
Time frame: At baseline visit and end visit (week 12)
Changes from baseline in serum triacylglycerol (TAG) in the CPH group as compared to placebo/casein
Time frame: At baseline visit and end visit (week 12)
Change from baseline in serum non-esterified fatty acids (NEFA) in the CPH group as compared to placebo/casein
Time frame: At baseline visit and end visit (week 12)
Change from baseline in serum non-HDL cholesterol in the CPH group as compared to placebo/casein
Time frame: At baseline visit and end visit (week 12)
Change from baseline in serum CRP in the CPH group as compared to placebo/casein
Time frame: At baseline visit and end visit (week 12)
Change from baseline in serum HDL cholesterol/LDL cholesterol size ratio in the CPH group as compared to placebo/casein
Time frame: At baseline visit and end visit (week 12)
Change from baseline in serum ceramides in the CPH group as compared to placebo/casein
Time frame: At baseline visit and end visit (week 12)
Change from baseline in fat mass/fat-free mass ratio in the CPH group as compared to placebo/casein
Time frame: At baseline visit and end visit (week 12)
Changes in antioxidant capacity in the CPH group as compared to placebo/casein at week 12
Time frame: At baseline visit and end visit (week 12)
Changes in serum acetylcarnitine/palmitoylcarnitine ratio in the CPH group as compared to placebo/casein at week 12
Time frame: At baseline visit and end visit (week 12)
Changes in serum octanoylcarnitine in the CPH group as compared to placebo/casein at week 12
Time frame: At baseline visit and end visit (week 12)
Changes in serum TMAO (trimethylamine N-oxide) in the CPH group as compared to placebo/casein at week 12
Time frame: At baseline visit and end visit (week 12)
Changes from baseline in the serum anti-inflammatory fatty acid index in the CPH group as compared to placebo at Week 12.
Time frame: At baseline visit and end visit (week 12)
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 29 Nov 2023.
- 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.
Rolf K Berge, PhD study director
University of Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chicken protein hydrolysate supplement in people with Abdominal Obesity, run by University of Bergen at 1 site in Norway.
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 4 inclusion and 8 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 29 Nov 2023. 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 Norway. 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?
Changes from baseline in waist circumference in the CPH group as compared to placebo/casein at week 12 (time frame: At baseline visit and end visit (week 12)). 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 Nov 2023.