Cognitive ImpairmentsNCT02778581
Study to Evaluate the Effect of a Vegetal Oil on Cognitive Impairment
A study testing Lipidic Blend 1 and Lipidic Blend 2 in people with Cognitive Impairments and Alzheimer Disease, run by Team Foods Colombia S.A. at 2 sites in Spain.
Trial summary
The aim of the study is to evaluate the beneficial effect of a mixture of vegetal oils with a composition related to short, medium and long unsaturated chain fatty acids on patients with a diagnose of cognitive impairment or mild to moderate Alzheimer disease Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Cognitive Impairments, Alzheimer Disease
- What is being tested?
- Lipidic Blend 1 and Lipidic Blend 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 2 sitesSpain
- Study dates
- Mar 2016to Jul 2017
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consents signed by patients and/or caretaker
- The patient has to fulfil dementia clinical criteria.
- Age between 55 and 85 years old.
- MMSE score between 18 and 26.
- The patient can fulfil all neuropsychologic test, according to investigator.
- The patient has to be always with his/her caretaker during monitorization visits
Show all 9Show fewer
- The caretaker has to be in regular contact with the patient, knowing his/her situation and participation in the study.
- The caretaker has to check four times per week, at least, the product intake, as well as the routine medication and his/her dietetic habits.
- Both caretaker and patient have to be able to complete the product intake during all the length of the study, according to the main investigator.
Who cannot join
- Patient and/or caretaker not being able to understand and agree in writing their participation in the study.
- Patient disability to oral intake of products.
- Known allergy to any of the product components (active and placebo)
- Evidence of suffering other neuropsychiatric disturbances apart of dementia as: Parkinson disease, psychotic disturbance, bipolar depression.
- regular intake of alcohol higher than 45 g ethanol/day, during the year before study inclusion.
- Any known concurrent malignant pathology in the moment of study inclusion, or severe metabolic, cardiovascular, renal, hepatic, or gastrointestinal disease that cannot allow the ending of the study according the investigator.
- Any analytical abnormality during the screening, apart from: Creatinine no less than 1.7 mg/dL; low levels of Vitamin B12, and TSH abnormal values.
Trial locations and contacts
2 sites in 1 country.
Vicente Navarro-López, MD contact
Miguel A Carrión-Gutiérrez, PhD contact
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Vinalopó
Elche, Alicante, 03293
Ana Fríes-Ramos, MD, afries@vinaloposalud.com
- Recruiting
Hospital Universitario de Torrevieja
Torrevieja, Alicante, 03186
Rosa Vela-Yebra, MD, rvela@torrevieja-salud.com
María A Méndez-Miralles, MD, mamendez@torrevieja-salud.com
About this study
Official title: Randomized, Double Blind, Placebo Controlled Prospective Study, to Evaluate the Effect of a Vegetal Oil in the Disease's Natural Evolution in Patients Diagnosed With Cognitive Impairment or Mild to Moderate Alzheimer Disease.
The aim of the study is to evaluate the beneficial effect of a mixture of vegetal oils with a composition related to short, medium and long unsaturated chain fatty acids on patients with a diagnose of cognitive impairment or mild to moderate Alzheimer disease
Read the detailed description
The cognitive impairment syndrome is defined as a decrease of the intellectual performance with respect to a previous step in time. The Cognitive impairment has to be considered as a functional alteration with a continuous and physiological evolution in which happen a set of different circumstances:
- A increasing and normal reduction, that appears after the age of sixty, also known as Age-associated memory impairment (AAMI)
- A mild cognitive impairment (MCI), with a recent and mild loss of memory, but higher to that expected because of patient's age and educational level.
- A severe pathological decrease of the mental abilities, also known as, depending on its characteristics: Severe cognitive impairment (SCI), senile dementia and Alzheimer's disease (1).
In the next years it is expected that this disease will become one of the main health and aged-related problem in aged people.(2) Nowadays, there are 35,6 million people with any kind of dementia, and it is estimated that every year, 7,7 million of new patients are diagnosed. (3) The amount of people affected will probably duplicate every 20 years, if effective treatments to stop its evolution are not developed. The forecast estimate up to 81,1 million of patients in 2040, which make this disease in a XXI century real epidemic.(4)
Before reaching the level of dementia, SCI or Alzheimer's disease, the patient will suffer a progressive mild cognitive impairment. In this level, the disease can be early diagnosed and it would be worth to act on it.
Evidences of the Polyunsaturated oils use on the prevention and/or treatment of cognitive impairment.
Polyunsaturated fatty acids (PUFA) can help to improve the cognitive functions. Neuronal tissues, as the brain, retina and the neurone-covering membranes (myelin) include high levels of PUFA. (5) PUFA's act on the order transmission in the Nervous System. Population studies reported the beneficial effect of fish oil, with a high PUFA concentration, on the memory of patients suffering a mild cognitive impairment. (6) It can be also beneficial for Alzheimer's patients, as they are deficient in PUFA's. A diet rich in PUFA'S can improve the cognitive function on patients con cognitive impairment and Alzheimer's disease. (6-8) Epidemiological studies suggest that oils rich in short chain PUFA, should play a beneficial role stopping the initial progression of Alzheimer's disease.
The previous data confirm the possibility of a beneficial effect of the product to study (a mixture of vegetable oils, rich in triglyceride and lecithins) due to the common characteristic of the product with those PUFA's already marketed.
- Conditions
- Cognitive Impairments, Alzheimer Disease
- Being tested
- Lipidic Blend 1, Lipidic Blend 2, Placebo
- Keywords
- Cognitive Impairment, Alzheimer's Disease, Vegetal Oil
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipidic Blend 1Dietary supplement
daily intake of the content of one 45 mL bottle containing the product
Lipidic Blend 2Dietary supplement
daily intake of the content of one 45 mL bottle containing the product
PlaceboDietary supplement
daily intake of the content of one 45 mL bottle containing olive oil
| Study group | Role | What they receive |
|---|---|---|
| Lipidic Blend 1 | Active comparator | Glass bottle with 45 ml of vegetal mixture oil. 1 bottle per day Receives: Dietary Supplement: Lipidic Blend 1 |
| Lipidic Blend 2 | Active comparator | Glass bottle with 45 ml of vegetal mixture oil. 1 bottle per day Receives: Dietary Supplement: Lipidic Blend 2 |
| Placebo | Placebo comparator | Glass bottle with 45 ml of Olive oil. 1 bottle per day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Mini-Mental State Examination (MMSE) score
Measured: baseline, 3 month, 6 month, 9 month, 12 month
Changes in Global Clinical Dementia Rating (CDR) score
Measured: baseline, 3 month, 6 month, 9 month, 12 month
Secondary outcomes (10)
Changes in systemic oxidative parameters in periferic blood samples (Nitric Oxyde)
Measured: baseline, 12 month
Changes in systemic oxidative parameters in periferic blood samples (Malondialdehyde (MDA))
Measured: baseline, 12 month
Changes in beta-amyloid protein concentration
Changes in mean values on high sensitivity beta-amyloid 1-40 and 1-42 protein and TAU-protein in cerebrospinal fluid on those patients with a new diagnose of mild to moderate cognitive impairment, that require an initial lumbar puncture and a new lumbar puncture to control evolution at the end of teh study.
Measured: baseline, 12 month
Changes in TAU-Protein concentration
Changes in mean values on high sensitivity beta-amyloid 1-40 and 1-42 protein and TAU-protein in cerebrospinal fluid on those patients with a new diagnose of mild to moderate cognitive impairment, that require an initial lumbar puncture and a new lumbar puncture to control evolution at the end of teh study.
Measured: baseline, 12 month
Changes in regular treatment for the cognitive impairment
Measured: baseline, 3 month, 6 month, 9 month, 12 month
Changes in dietetic habits
Measured: baseline, 3 month, 6 month, 9 month, 12 month
Changes in Barthel score
Measured: baseline, 3 month, 6 month, 9 month, 12 month
Changes in Morisky-Green score
Measured: baseline, 3 month, 6 month, 9 month, 12 month
changes in weight
Measured: baseline, 3 month, 6 month, 9 month, 12 month
Number of adverse events
Number of adverse events related or nonrelated to the study or placebo products.
Measured: baseline, 3 month, 6 month, 9 month, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentsStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Team Foods Colombia S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biopolis S.L.
- Responsible party
- Sponsor
- Investigators
- Vicente Navarro-López, MD, Study director, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778581
- Sponsor's protocol ID
- ALZ-OIL.01
- Status last verified
- May 2016
- First submitted
- 8 May 2016
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kueider AM, Parisi JM, Gross AL, Rebok GW. Computerized cognitive training with older adults: a systematic review. PLoS One. 2012;7(7):e40588. doi: 10.1371/journal.pone.0040588. Epub 2012 Jul 11.
PubMed 22792378Luck T, Luppa M, Briel S, Riedel-Heller SG. Incidence of mild cognitive impairment: a systematic review. Dement Geriatr Cogn Disord. 2010;29(2):164-75. doi: 10.1159/000272424. Epub 2010 Feb 11.
PubMed 20150735Coronado M, et al. Los ácidos grasos omega-3 y omega-6: Nutrición, bioquímica y salud. REB 25(3) 2006: 72-79
Swanson D, Block R, Mousa SA. Omega-3 fatty acids EPA and DHA: health benefits throughout life. Adv Nutr. 2012 Jan;3(1):1-7. doi: 10.3945/an.111.000893. Epub 2012 Jan 5.
PubMed 22332096Lee LK, Shahar S, Chin AV, Yusoff NA. Docosahexaenoic acid-concentrated fish oil supplementation in subjects with mild cognitive impairment (MCI): a 12-month randomised, double-blind, placebo-controlled trial. Psychopharmacology (Berl). 2013 Feb;225(3):605-12. doi: 10.1007/s00213-012-2848-0. Epub 2012 Aug 30.
PubMed 22932777Larrieu S, Letenneur L, Berr C, Dartigues JF, Ritchie K, Alperovitch A, Tavernier B, Barberger-Gateau P. Sociodemographic differences in dietary habits in a population-based sample of elderly subjects: the 3C study. J Nutr Health Aging. 2004;8(6):497-502.
PubMed 15543423Gillette Guyonnet S, Abellan Van Kan G, Andrieu S, Barberger Gateau P, Berr C, Bonnefoy M, Dartigues JF, de Groot L, Ferry M, Galan P, Hercberg S, Jeandel C, Morris MC, Nourhashemi F, Payette H, Poulain JP, Portet F, Roussel AM, Ritz P, Rolland Y, Vellas B. IANA task force on nutrition and cognitive decline with aging. J Nutr Health Aging. 2007 Mar-Apr;11(2):132-52.
PubMed 17435956Logan AC. Neurobehavioral aspects of omega-3 fatty acids: possible mechanisms and therapeutic value in major depression. Altern Med Rev. 2003 Nov;8(4):410-25.
PubMed 14653768Bourre JM. Roles of unsaturated fatty acids (especially omega-3 fatty acids) in the brain at various ages and during ageing. J Nutr Health Aging. 2004;8(3):163-74.
PubMed 15129302
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Controlled Prospective Study, to Evaluate the Effect of a Vegetal Oil in the Disease's Natural Evolution in Patients Diagnosed With Cognitive Impairment or Mild to Moderate Alzheimer Disease.
- ClinicalTrials.gov ID
- NCT02778581
- Acronym / sponsor ID
- ALZ-OIL.01
- Conditions
- Cognitive Impairments, Alzheimer Disease
- Keywords
- Cognitive Impairment, Alzheimer's Disease, Vegetal Oil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Team Foods Colombia S.A.Industry (pharma, biotech, devices)
- Collaborators
- Biopolis S.L.
- Study start
- Mar 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 20 May 2016 (estimated)
- 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 aim of the study is to evaluate the beneficial effect of a mixture of vegetal oils with a composition related to short, medium and long unsaturated chain fatty acids on patients with a diagnose of cognitive impairment or mild to moderate Alzheimer disease
Detailed description
The cognitive impairment syndrome is defined as a decrease of the intellectual performance with respect to a previous step in time. The Cognitive impairment has to be considered as a functional alteration with a continuous and physiological evolution in which happen a set of different circumstances:
- A increasing and normal reduction, that appears after the age of sixty, also known as Age-associated memory impairment (AAMI)
- A mild cognitive impairment (MCI), with a recent and mild loss of memory, but higher to that expected because of patient's age and educational level.
- A severe pathological decrease of the mental abilities, also known as, depending on its characteristics: Severe cognitive impairment (SCI), senile dementia and Alzheimer's disease (1).
In the next years it is expected that this disease will become one of the main health and aged-related problem in aged people.(2) Nowadays, there are 35,6 million people with any kind of dementia, and it is estimated that every year, 7,7 million of new patients are diagnosed. (3) The amount of people affected will probably duplicate every 20 years, if effective treatments to stop its evolution are not developed. The forecast estimate up to 81,1 million of patients in 2040, which make this disease in a XXI century real epidemic.(4)
Before reaching the level of dementia, SCI or Alzheimer's disease, the patient will suffer a progressive mild cognitive impairment. In this level, the disease can be early diagnosed and it would be worth to act on it.
Evidences of the Polyunsaturated oils use on the prevention and/or treatment of cognitive impairment.
Polyunsaturated fatty acids (PUFA) can help to improve the cognitive functions. Neuronal tissues, as the brain, retina and the neurone-covering membranes (myelin) include high levels of PUFA. (5) PUFA's act on the order transmission in the Nervous System. Population studies reported the beneficial effect of fish oil, with a high PUFA concentration, on the memory of patients suffering a mild cognitive impairment. (6) It can be also beneficial for Alzheimer's patients, as they are deficient in PUFA's. A diet rich in PUFA'S can improve the cognitive function on patients con cognitive impairment and Alzheimer's disease. (6-8) Epidemiological studies suggest that oils rich in short chain PUFA, should play a beneficial role stopping the initial progression of Alzheimer's disease.
The previous data confirm the possibility of a beneficial effect of the product to study (a mixture of vegetable oils, rich in triglyceride and lecithins) due to the common characteristic of the product with those PUFA's already marketed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lipidic Blend 1 | Active comparator | Dietary Supplement: Lipidic Blend 1Glass bottle with 45 ml of vegetal mixture oil. 1 bottle per day |
| Lipidic Blend 2 | Active comparator | Dietary Supplement: Lipidic Blend 2Glass bottle with 45 ml of vegetal mixture oil. 1 bottle per day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboGlass bottle with 45 ml of Olive oil. 1 bottle per day |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- informed consents signed by patients and/or caretaker
- The patient has to fulfil dementia clinical criteria.
- Age between 55 and 85 years old.
- MMSE score between 18 and 26.
- The patient can fulfil all neuropsychologic test, according to investigator.
Key exclusion criteria (7 listed)
- Patient and/or caretaker not being able to understand and agree in writing their participation in the study.
- Patient disability to oral intake of products.
- Known allergy to any of the product components (active and placebo)
- Evidence of suffering other neuropsychiatric disturbances apart of dementia as: Parkinson disease, psychotic disturbance, bipolar depression.
- regular intake of alcohol higher than 45 g ethanol/day, during the year before study inclusion.
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 |
|---|---|---|
| Lipidic Blend 1daily intake of the content of one 45 mL bottle containing the product | Dietary supplement | Lipidic Blend 1 |
| Lipidic Blend 2daily intake of the content of one 45 mL bottle containing the product | Dietary supplement | Lipidic Blend 2 |
| Placebodaily intake of the content of one 45 mL bottle containing olive oil | Dietary supplement | Placebo |
Primary outcome
Changes in Mini-Mental State Examination (MMSE) score
Time frame: baseline, 3 month, 6 month, 9 month, 12 month
Changes in Global Clinical Dementia Rating (CDR) score
Time frame: baseline, 3 month, 6 month, 9 month, 12 month
10 secondary outcomes
Changes in systemic oxidative parameters in periferic blood samples (Nitric Oxyde)
Time frame: baseline, 12 month
Changes in systemic oxidative parameters in periferic blood samples (Malondialdehyde (MDA))
Time frame: baseline, 12 month
Changes in beta-amyloid protein concentration
Time frame: baseline, 12 month
Changes in TAU-Protein concentration
Time frame: baseline, 12 month
Changes in regular treatment for the cognitive impairment
Time frame: baseline, 3 month, 6 month, 9 month, 12 month
Changes in dietetic habits
Time frame: baseline, 3 month, 6 month, 9 month, 12 month
Changes in Barthel score
Time frame: baseline, 3 month, 6 month, 9 month, 12 month
Changes in Morisky-Green score
Time frame: baseline, 3 month, 6 month, 9 month, 12 month
changes in weight
Time frame: baseline, 3 month, 6 month, 9 month, 12 month
Number of adverse events
Time frame: baseline, 3 month, 6 month, 9 month, 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Background: PubMed 22792378Kueider AM, Parisi JM, Gross AL, Rebok GW. Computerized cognitive training with older adults: a systematic review. PLoS One. 2012;7(7):e40588. doi: 10.1371/journal.pone.0040588. Epub 2012 Jul 11.
- Background: PubMed 20150735Luck T, Luppa M, Briel S, Riedel-Heller SG. Incidence of mild cognitive impairment: a systematic review. Dement Geriatr Cogn Disord. 2010;29(2):164-75. doi: 10.1159/000272424. Epub 2010 Feb 11.
- BackgroundCoronado M, et al. Los ácidos grasos omega-3 y omega-6: Nutrición, bioquímica y salud. REB 25(3) 2006: 72-79
- Background: PubMed 22332096Swanson D, Block R, Mousa SA. Omega-3 fatty acids EPA and DHA: health benefits throughout life. Adv Nutr. 2012 Jan;3(1):1-7. doi: 10.3945/an.111.000893. Epub 2012 Jan 5.
- Background: PubMed 22932777Lee LK, Shahar S, Chin AV, Yusoff NA. Docosahexaenoic acid-concentrated fish oil supplementation in subjects with mild cognitive impairment (MCI): a 12-month randomised, double-blind, placebo-controlled trial. Psychopharmacology (Berl). 2013 Feb;225(3):605-12. doi: 10.1007/s00213-012-2848-0. Epub 2012 Aug 30.
- Background: PubMed 15543423Larrieu S, Letenneur L, Berr C, Dartigues JF, Ritchie K, Alperovitch A, Tavernier B, Barberger-Gateau P. Sociodemographic differences in dietary habits in a population-based sample of elderly subjects: the 3C study. J Nutr Health Aging. 2004;8(6):497-502.
- Background: PubMed 17435956Gillette Guyonnet S, Abellan Van Kan G, Andrieu S, Barberger Gateau P, Berr C, Bonnefoy M, Dartigues JF, de Groot L, Ferry M, Galan P, Hercberg S, Jeandel C, Morris MC, Nourhashemi F, Payette H, Poulain JP, Portet F, Roussel AM, Ritz P, Rolland Y, Vellas B. IANA task force on nutrition and cognitive decline with aging. J Nutr Health Aging. 2007 Mar-Apr;11(2):132-52.
- Background: PubMed 14653768Logan AC. Neurobehavioral aspects of omega-3 fatty acids: possible mechanisms and therapeutic value in major depression. Altern Med Rev. 2003 Nov;8(4):410-25.
- Background: PubMed 15129302Bourre JM. Roles of unsaturated fatty acids (especially omega-3 fatty acids) in the brain at various ages and during ageing. J Nutr Health Aging. 2004;8(3):163-74.
- World Health Organization. Dementia. Fact sheet 362. Published March 2015Link provided by the sponsor.
- El deterioro cognitivo leve (DCL) en la edad de oroLink provided by the sponsor.
- 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.
Vicente Navarro-López, MD contact
Miguel A Carrión-Gutiérrez, PhD contact
Vicente Navarro-López, MD study director
Universidad Católica San Antonio de Murcia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipidic Blend 1 and Lipidic Blend 2 in people with Cognitive Impairments and Alzheimer Disease, run by Team Foods Colombia S.A. at 2 sites in Spain.
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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vicente Navarro-López, MD (vnavarro@ucam.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Mini-Mental State Examination (MMSE) score (time frame: baseline, 3 month, 6 month, 9 month, 12 month). The study lists 2 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 NCT02778581, which also lists 9 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 3 Jun 2016.