HypercholesterolemiaNCT05267522
Independent Effects of High-cholesterol (High-egg) and High-saturated Fat Diets on LDL-cholesterol
A study testing Egg diet and Egg-free Diet in people with Hypercholesterolemia and Hyperlipidemias, run by University of South Australia at 1 site in Australia.
Trial summary
This study will comprise a randomized controlled, counter-balanced, cross-over trial to evaluate the independent effects of a high cholesterol (high egg), low saturated fat diet and a high saturated fat, low cholesterol diet on blood lipids. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Hyperlipidemias, Physical Inactivity
- What is being tested?
- Egg diet and Egg-free Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Mar 2022to 31 Aug 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, aged 18 - 60 years
- Blood LDL-C <3.5 mmol/L (measured at screening using an automated analyser (Cholestech LDX System).
- Non-smoker (or other nicotine products) (minimum 6 months).
Who cannot join
- Have diagnosed cardiovascular disease (including uncontrolled high blood pressure) or a chronic disease, including Type-1 or -2 diabetes, kidney or liver disease, gastrointestinal disorders requiring medical nutrition therapy (e.g., Crohn's disease, irritable bowel, coeliac disease) or any other condition that may have an impact on study outcomes.
- Have allergies or strong aversion to eggs or other components of the test foods (diets are not suitable for vegetarians).
- Consume more than 5 eggs per week in the month prior to beginning the trial.
- Participant has a recent history (within 12 months) or strong potential for alcohol abuse. Defined as >14 standard drinks per week.
- Have changed medication or supplementation that might affect study outcomes in the last 3 months.
- Take vitamin, mineral, herbal supplementation, or medications that may have an impact on study outcomes.
Show all 11Show fewer
- Are already involved in another research project within 30 days of commencement of the present study that in the opinion of the investigators will be unsuitable for this study.
- Are pregnant or breastfeeding.
- Show unwillingness to be randomized to either experimental group.
- Failure to satisfy the investigator regarding suitability to participate for any other reason.
- Are unwilling or unable to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
Australia1 site
University of South Australia Clinical Trial Facility
Adelaide, South Australia, 5000
About this study
This study will comprise a randomized controlled, counter-balanced, cross-over trial to evaluate the independent effects of a high cholesterol (high egg), low saturated fat diet and a high saturated fat, low cholesterol diet on blood lipids. Evaluations also include analysis of physical activity as there is emerging evidence that the lutein and zeaxanthin in egg yolk may increase physical activity levels by crossing the blood-brain barrier and altering neuronal function. The study will also investigate effects on a number of novel lipoprotein parameters (particle size and particle concentrations).
Read the detailed description
Eggs are high in cholesterol but low in saturated fat. Data from cross-sectional, prospective, and randomized controlled trials (RCTs), suggest that egg intake does not adversely affect blood lipids or increase cardiovascular disease (CVD) risk. In fact, there is some evidence that egg consumption may reduce CVD risk. However, to date there has been no direct comparison of the effects of a high cholesterol (high egg), low saturated fat diet and a low cholesterol, high-saturated fat diet on blood lipids, and no studies have accounted for potential effects of differences in physical activity, which can also influence the blood lipid profile. Evaluations of the effect of egg consumption on blood lipids should include analysis of physical activity as there is emerging evidence that the lutein and zeaxanthin in egg yolk may increase physical activity levels by crossing the blood-brain barrier and altering neuronal function. We will directly compare the effects of a high cholesterol, low saturated fat diet and a low cholesterol, high saturated fat diet on blood lipids, using egg consumption to manipulate dietary cholesterol intake, while also accounting for physical activity levels. The study will investigate effects on a number of novel lipoprotein parameters (particle size and particle concentrations).
- Being tested
- Egg diet, Egg-free Diet, Control Diet
- Keywords
- Cholesterol, Eggs, Saturated Fat, Low density lipoprotein cholesterol, lutein, physical activity
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg dietOther
Also called High cholesterol + low saturated fat diet
30% fat [6% saturated fat], 20% protein, 40% carbohydrate, 600 mg cholesterol
Egg-free DietOther
Also called Low cholesterol + high saturated fat diet
30% fat [12% saturated fat], 25% protein, 40% carbohydrate, 300 mg cholesterol
Control DietOther
Also called Average Australian Diet
30% fat [12% saturated fat], 25% protein, 40% carbohydrate, 600 mg cholesterol
| Study group | Role | What they receive |
|---|---|---|
| Egg Diet | Experimental | Egg diet, contains 2 eggs per day and limits saturated fat to 6% of energy intake. Cholesterol intake is 600mg/day. Protein and carbohydrate levels will be maintained at 20% and 40% of energy intake, respectively. This diet will be followed for 5 weeks. Receives: Other: Egg diet |
| Egg-free Diet | Active comparator | Egg-free diet, limits cholesterol to 300 mg/day (no eggs) with saturated fat intake at 12% of energy intake. Protein and carbohydrate levels will be maintained at 25% and 40% of energy intake, respectively. This diet will be followed for 5 weeks. Receives: Other: Egg-free Diet |
| Control Diet | Active comparator | Comparator diet based on the average Australian diet, limited to 1 egg per week, with saturated fat intake at 12% of energy intake. Cholesterol intake is 600 mg/day. Protein and carbohydrate levels will be maintained at 25% and 40% of energy intake, respectively. This diet will be followed for 5 weeks. Receives: Other: Control Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low-density lipoprotein cholesterol (LDL-C)
Plasma LDL-C levels (mmol/L)
Measured: Baseline
Low-density lipoprotein cholesterol (LDL-C)
Plasma LDL-C levels (mmol/L)
Measured: 5 weeks
Low-density lipoprotein cholesterol (LDL-C)
Plasma LDL-C levels (mmol/L)
Measured: 10 weeks
Low-density lipoprotein cholesterol (LDL-C)
Plasma LDL-C levels (mmol/L)
Measured: 15 weeks
Secondary outcomes (44)
Blood lipid profiling
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
Measured: Baseline
Blood lipid profiling
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
Measured: 5 weeks
Blood lipid profiling
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
Measured: 10 weeks
Blood lipid profiling
Plasma lipid, lipoprotein subclasses, cholesterol, and apolipoproteins
Measured: 15 weeks
Fasting glucose
Plasma glucose levels (mmol/L)
Measured: Baseline
Fasting glucose
Plasma glucose levels (mmol/L)
Measured: 5 weeks
Fasting glucose
Plasma glucose levels (mmol/L)
Measured: 10 weeks
Fasting glucose
Plasma glucose levels (mmol/L)
Measured: 15 weeks
Physical activity levels
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
Measured: Baseline
Physical activity levels
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
Measured: 5 weeks
Physical activity levels
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
Measured: 10 weeks
Physical activity levels
Amount of time (min) spent sedentary and engaged in light or moderate-vigorous physical activity
Measured: 15 weeks
Waist circumference
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
Measured: Baseline
Waist circumference
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
Measured: 5 weeks
Waist circumference
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
Measured: 10 weeks
Waist circumference
Waist circumference (cm) measured at the midpoint between the lower costal (10th rib) border and the iliac crest.
Measured: 15 weeks
Blood Pressure
Seated blood pressure (mmHg)
Measured: Baseline
Blood Pressure
Seated blood pressure (mmHg)
Measured: 5 weeks
Blood Pressure
Seated blood pressure (mmHg)
Measured: 10 weeks
Blood Pressure
Seated blood pressure (mmHg)
Measured: 15 weeks
Dietary saturated fat intake
Analysis of dietary intake based on 5-day food diaries
Measured: Baseline
Dietary saturated fat intake
Analysis of dietary intake based on 5-day food diaries
Measured: 5 weeks
Dietary saturated fat intake
Analysis of dietary intake based on 5-day food diaries
Measured: 10 weeks
Dietary saturated fat intake
Analysis of dietary intake based on 5-day food diaries
Measured: 15 weeks
Dietary cholesterol intake
Analysis of dietary intake based on 5-day food diaries
Measured: Baseline
Dietary cholesterol intake
Analysis of dietary intake based on 5-day food diaries
Measured: 5 weeks
Dietary cholesterol intake
Analysis of dietary intake based on 5-day food diaries
Measured: 10 weeks
Dietary cholesterol intake
Analysis of dietary intake based on 5-day food diaries
Measured: 15 weeks
Dietary Energy intake
Analysis of dietary intake based on 5-day food diaries
Measured: Baseline
Dietary Energy intake
Analysis of dietary intake based on 5-day food diaries
Measured: 5 weeks
Dietary Energy intake
Analysis of dietary intake based on 5-day food diaries
Measured: 10 weeks
Dietary Energy intake
Analysis of dietary intake based on 5-day food diaries
Measured: 15 weeks
Dietary Macronutrients
Analysis of dietary intake based on food diaries
Measured: Baseline
Dietary Macronutrients
Analysis of dietary intake based on food diaries
Measured: 5 weeks
Dietary Macronutrients
Analysis of dietary intake based on food diaries
Measured: 10 weeks
Dietary Macronutrients
Analysis of dietary intake based on food diaries
Measured: 15 weeks
Dietary Lutein+Zeaxanthin
Analysis of dietary intake based on food diaries
Measured: Baseline
Dietary Lutein+Zeaxanthin
Analysis of dietary intake based on food diaries
Measured: 5 weeks
Dietary Lutein+Zeaxanthin
Analysis of dietary intake based on food diaries
Measured: 10 weeks
Dietary Lutein+Zeaxanthin
Analysis of dietary intake based on food diaries
Measured: 15 weeks
Sleep
Sleep patterns assessed using accelerometers
Measured: Baseline
Sleep
Sleep patterns assessed using accelerometers
Measured: 5 weeks
Sleep
Sleep patterns assessed using accelerometers
Measured: 10 weeks
Sleep
Sleep patterns assessed using accelerometers
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Mar 2022
- Primary completion10 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Counter-balanced, cross-over trial with randomization to the starting diet will be via minimization, based on the LDL-C concentration at screening and sex. Minimization will ensure balanced LDL-C and sex between the treatment groups at commencement of each of the three diets.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Australia
- Sponsor type
- University, hospital or other
- Collaborators
- American Egg Board
- Responsible party
- Principal investigator, Prof. Jonathan Buckley, University of South Australia
- Investigators
- Jonathan D Buckley, PhD, Principal investigator, University of South Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267522
- Sponsor's protocol ID
- 204327
- Status last verified
- Mar 2022
- First submitted
- 2 Feb 2022
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carter S, Hill AM, Yandell C, Wood L, Coates AM, Buckley JD. Impact of dietary cholesterol from eggs and saturated fat on LDL cholesterol levels: a randomized cross-over study. Am J Clin Nutr. 2025 Jul;122(1):83-91. doi: 10.1016/j.ajcnut.2025.05.001. Epub 2025 May 6.
PubMed 40339906Carter S, Hill AM, Yandell C, Buckley JD, Coates AM. Study protocol for a 15-week randomised controlled trial assessing the independent effects of high-cholesterol and high-saturated fat diets on LDL cholesterol. BMJ Open. 2024 Jan 25;14(1):e081664. doi: 10.1136/bmjopen-2023-081664.
PubMed 38272555
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independent Effects of High-cholesterol (High-egg) and High-saturated Fat Diets on LDL-cholesterol
- ClinicalTrials.gov ID
- NCT05267522
- Acronym / sponsor ID
- 204327
- Keywords
- Cholesterol, Eggs, Saturated Fat, Low density lipoprotein cholesterol, lutein, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of South AustraliaUniversity, hospital or other
- Collaborators
- American Egg Board
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 4 Mar 2022 (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.
This study will comprise a randomized controlled, counter-balanced, cross-over trial to evaluate the independent effects of a high cholesterol (high egg), low saturated fat diet and a high saturated fat, low cholesterol diet on blood lipids. Evaluations also include analysis of physical activity as there is emerging evidence that the lutein and zeaxanthin in egg yolk may increase physical activity levels by crossing the blood-brain barrier and altering neuronal function. The study will also investigate effects on a number of novel lipoprotein parameters (particle size and particle concentrations).
Detailed description
Eggs are high in cholesterol but low in saturated fat. Data from cross-sectional, prospective, and randomized controlled trials (RCTs), suggest that egg intake does not adversely affect blood lipids or increase cardiovascular disease (CVD) risk. In fact, there is some evidence that egg consumption may reduce CVD risk. However, to date there has been no direct comparison of the effects of a high cholesterol (high egg), low saturated fat diet and a low cholesterol, high-saturated fat diet on blood lipids, and no studies have accounted for potential effects of differences in physical activity, which can also influence the blood lipid profile. Evaluations of the effect of egg consumption on blood lipids should include analysis of physical activity as there is emerging evidence that the lutein and zeaxanthin in egg yolk may increase physical activity levels by crossing the blood-brain barrier and altering neuronal function. We will directly compare the effects of a high cholesterol, low saturated fat diet and a low cholesterol, high saturated fat diet on blood lipids, using egg consumption to manipulate dietary cholesterol intake, while also accounting for physical activity levels. The study will investigate effects on a number of novel lipoprotein parameters (particle size and particle concentrations).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Counter-balanced, cross-over trial with randomization to the starting diet will be via minimization, based on the LDL-C concentration at screening and sex. Minimization will ensure balanced LDL-C and sex between the treatment groups at commencement of each of the three diets.
| Arm | Type | Receives |
|---|---|---|
| Egg Diet | Experimental | Other: Egg dietEgg diet, contains 2 eggs per day and limits saturated fat to 6% of energy intake. Cholesterol intake is 600mg/day. Protein and carbohydrate levels will be maintained at 20% and 40% of energy intake, respectively. This diet will be followed for 5 weeks. |
| Egg-free Diet | Active comparator | Other: Egg-free DietEgg-free diet, limits cholesterol to 300 mg/day (no eggs) with saturated fat intake at 12% of energy intake. Protein and carbohydrate levels will be maintained at 25% and 40% of energy intake, respectively. This diet will be followed for 5 weeks. |
| Control Diet | Active comparator | Other: Control DietComparator diet based on the average Australian diet, limited to 1 egg per week, with saturated fat intake at 12% of energy intake. Cholesterol intake is 600 mg/day. Protein and carbohydrate levels will be maintained at 25% and 40% of energy intake, respectively. This diet will be followed for 5 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female, aged 18 - 60 years
- Blood LDL-C <3.5 mmol/L (measured at screening using an automated analyser (Cholestech LDX System).
- Non-smoker (or other nicotine products) (minimum 6 months).
Key exclusion criteria (11 listed)
- Have diagnosed cardiovascular disease (including uncontrolled high blood pressure) or a chronic disease, including Type-1 or -2 diabetes, kidney or liver disease, gastrointestinal disorders requiring medical nutrition therapy (e.g., Crohn's disease, irritable bowel, coeliac disease) or any other condition that may have an impact on study outcomes.
- Have allergies or strong aversion to eggs or other components of the test foods (diets are not suitable for vegetarians).
- Consume more than 5 eggs per week in the month prior to beginning the trial.
- Participant has a recent history (within 12 months) or strong potential for alcohol abuse. Defined as >14 standard drinks per week.
- Have changed medication or supplementation that might affect study outcomes in the last 3 months.
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 |
|---|---|---|
| Egg dietAlso: High cholesterol + low saturated fat diet30% fat [6% saturated fat], 20% protein, 40% carbohydrate, 600 mg cholesterol | Other | Egg Diet |
| Egg-free DietAlso: Low cholesterol + high saturated fat diet30% fat [12% saturated fat], 25% protein, 40% carbohydrate, 300 mg cholesterol | Other | Egg-free Diet |
| Control DietAlso: Average Australian Diet30% fat [12% saturated fat], 25% protein, 40% carbohydrate, 600 mg cholesterol | Other | Control Diet |
Primary outcome
Low-density lipoprotein cholesterol (LDL-C)
Time frame: Baseline
Plasma LDL-C levels (mmol/L)
Low-density lipoprotein cholesterol (LDL-C)
Time frame: 5 weeks
Plasma LDL-C levels (mmol/L)
Low-density lipoprotein cholesterol (LDL-C)
Time frame: 10 weeks
Plasma LDL-C levels (mmol/L)
Low-density lipoprotein cholesterol (LDL-C)
Time frame: 15 weeks
Plasma LDL-C levels (mmol/L)
44 secondary outcomes
Blood lipid profiling
Time frame: Baseline
Blood lipid profiling
Time frame: 5 weeks
Blood lipid profiling
Time frame: 10 weeks
Blood lipid profiling
Time frame: 15 weeks
Fasting glucose
Time frame: Baseline
Fasting glucose
Time frame: 5 weeks
Fasting glucose
Time frame: 10 weeks
Fasting glucose
Time frame: 15 weeks
Physical activity levels
Time frame: Baseline
Physical activity levels
Time frame: 5 weeks
Physical activity levels
Time frame: 10 weeks
Physical activity levels
Time frame: 15 weeks
Waist circumference
Time frame: Baseline
Waist circumference
Time frame: 5 weeks
Waist circumference
Time frame: 10 weeks
Waist circumference
Time frame: 15 weeks
Blood Pressure
Time frame: Baseline
Blood Pressure
Time frame: 5 weeks
Blood Pressure
Time frame: 10 weeks
Blood Pressure
Time frame: 15 weeks
Dietary saturated fat intake
Time frame: Baseline
Dietary saturated fat intake
Time frame: 5 weeks
Dietary saturated fat intake
Time frame: 10 weeks
Dietary saturated fat intake
Time frame: 15 weeks
Dietary cholesterol intake
Time frame: Baseline
Dietary cholesterol intake
Time frame: 5 weeks
Dietary cholesterol intake
Time frame: 10 weeks
Dietary cholesterol intake
Time frame: 15 weeks
Dietary Energy intake
Time frame: Baseline
Dietary Energy intake
Time frame: 5 weeks
Dietary Energy intake
Time frame: 10 weeks
Dietary Energy intake
Time frame: 15 weeks
Dietary Macronutrients
Time frame: Baseline
Dietary Macronutrients
Time frame: 5 weeks
Dietary Macronutrients
Time frame: 10 weeks
Dietary Macronutrients
Time frame: 15 weeks
Dietary Lutein+Zeaxanthin
Time frame: Baseline
Dietary Lutein+Zeaxanthin
Time frame: 5 weeks
Dietary Lutein+Zeaxanthin
Time frame: 10 weeks
Dietary Lutein+Zeaxanthin
Time frame: 15 weeks
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 2023.
- Derived from this study: PubMed 40339906Carter S, Hill AM, Yandell C, Wood L, Coates AM, Buckley JD. Impact of dietary cholesterol from eggs and saturated fat on LDL cholesterol levels: a randomized cross-over study. Am J Clin Nutr. 2025 Jul;122(1):83-91. doi: 10.1016/j.ajcnut.2025.05.001. Epub 2025 May 6.
- Derived from this study: PubMed 38272555Carter S, Hill AM, Yandell C, Buckley JD, Coates AM. Study protocol for a 15-week randomised controlled trial assessing the independent effects of high-cholesterol and high-saturated fat diets on LDL cholesterol. BMJ Open. 2024 Jan 25;14(1):e081664. doi: 10.1136/bmjopen-2023-081664.
- 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.
Jonathan D Buckley, PhD principal investigator
University of South Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Egg diet and Egg-free Diet in people with Hypercholesterolemia and Hyperlipidemias, run by University of South Australia at 1 site in Australia.
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 11 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 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 Australia. 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?
Low-density lipoprotein cholesterol (LDL-C) (time frame: Baseline). The study lists 4 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 NCT05267522, which also lists 2 linked publications.
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 2023.