Healthy AgeingNCT02996578
Effect of Polyphenol-rich Cocoa Products on Cognitive Function
A study testing polyphenol rich chocolate bar, polyphenol rich cocoa powder and low polyphenol content chocolate bar in people with Healthy Ageing, run by Queen Margaret University at 1 site in United Kingdom.
Trial summary
This project aims to investigate whether consumption of cocoa polyphenols has an impact on cognitive function in individuals aged 50 to 60 years of age and if such an improvement is a result of an improvement in risk factors associated with cognitive decline in ageing. Read more about this study
- Who is it for?
- Ages 50 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Ageing
- What is being tested?
- polyphenol rich chocolate bar, polyphenol rich cocoa powder and low polyphenol content chocolate bar
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Apr 2017to 30 Sep 2018
- 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 50 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males \& Females aged 50-60years of age with normal or corrected to normal vision
- BMI cut off points of ≥18.5 to ≤29.9 kg/m2
- Waist circumference smaller than 102cm for males \& smaller than 88cm for women
- Blood pressure of ≥ 90 over 60 and ≤ 120 over 80
- MoCA test score ≥ 26
Who cannot join
- Allergies to cocoa or any other ingredients commonly found in cocoa confectionary eg: milk, nuts, soya
- Smoker
- Women who are new or expecting mothers, maybe or are currently pregnant and/or breastfeeding
- Taking medications for chronic conditions including (but not limited to) diabetes, heart disease, hypertension
- No previous history of stroke, brain trauma and other head-related injuries
- No diagnosis of depression and/or anxiety
Show all 15Show fewer
- No previous cancer diagnosis
- Taking antibiotics
- Taking steroids and non-steroidal anti-inflammatory drugs (NSAIDS)
- Women on Hormone Replacement Therapy (HRT)
- Taking medication that can cause drowsiness or affect cognitive functioning
- Taking polyphenol supplements including (but not limited to) green tea extract, acai berry extract
- Taking soy/a supplements
- History of alcohol misuse
- Fear of needles and/or fainting when blood is taken
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Consumption of Polyphenol Rich Cocoa Products Over 8 Weeks and Its Effect on Cognitive Function in Individuals in Their 5th Decade of Life.
This project aims to investigate whether consumption of cocoa polyphenols has an impact on cognitive function in individuals aged 50 to 60 years of age and if such an improvement is a result of an improvement in risk factors associated with cognitive decline in ageing.
Read the detailed description
Healthy cognitive ageing is an important aspect of the ageing process as it involves larger numbers of people compared to those who have already been diagnosed with conditions on the dementia spectrum (Deary et al, 2009). Hence, an active effort looking at potential lifestyle factor modification interventions to help maintain cognitive well-being are warranted.
With an ageing population, the prevalence of cognitive syndromes such as Alzheimer's disease and Parkinson's disease increases (Vauzour, 2012). Nutritional interventions can play a role in successful ageing by helping to delay the onset of age-related conditions (Hendrickx, McEwen \& van der Ouderaa, 2005; Brown, Riby \& Reay, 2009; Monti, Moulton \& Cohen, 2015). Studies have investigated the potential role of polyphenols as part of a neuroprotective lifestyle. Mouse model studies have looked at varying polyphenol sources such as tea (Haque et al., 2006; Kaur et al., 2008), blueberry (Shukitt-Hale et al., 2015; Williams et al., 2008), Gingko Biloba (Shif et al., 2008) and cocoa (Bisson et al., 2008) to mention a few.
Ageing and neurodegenerative diseases are caused by neuronal death which in turn can be triggered by neurotoxins, neuroinflammation and specific genetic mutations (Bishop, Lu \& Yankner, 2010). Dietary polyphenols have been observed to provide neuroprotection against cellular alteration by modulating the neuronal function against endogenous neurotoxins and inhibition of glial induced neuroinflammation (Vauzour, 2012).
- Conditions
- Healthy Ageing
- Being tested
- polyphenol rich chocolate bar, polyphenol rich cocoa powder, low polyphenol content chocolate bar, low polyphenol content cocoa powder
- Keywords
- Cognition, Cacao, Flavan-3-ols, Blood Pressure, hemoglobin A1c protein, human, Memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyphenol rich chocolate barDietary supplement
High polyphenol content chocolate bar. Each participant will consume 581.4mg of polyphenols
polyphenol rich cocoa powderDietary supplement
High polyphenol content cocoa powder. Each participant will consume 6g containing 554mg of polyphenols
low polyphenol content chocolate barDietary supplement
Low polyphenol content matched chocolate bar. Each participant will consume 198.5mg of polyphenols
low polyphenol content cocoa powderDietary supplement
Low polyphenol content cocoa powder. Each participant will consume 6g containing 191.2mg of polyphenols
| Study group | Role | What they receive |
|---|---|---|
| Solid Matrix - Intervention | Active comparator | Dietary Supplement: polyphenol rich chocolate bar
17.5g of commercially available dark chocolate will be consumed daily for 8 weeks Receives: Dietary Supplement: polyphenol rich chocolate bar |
| Powder Matrix - Intervention | Active comparator | Dietary Supplement: polyphenol rich cocoa powder
6g of commercially available cocoa powder (provided as 6 x 1g gelatine capsules) will be consumed daily for 8 weeks Receives: Dietary Supplement: polyphenol rich cocoa powder |
| Solid Matrix Intervention - Placebo | Placebo comparator | Dietary Supplement: low polyphenol chocolate
17.5g of commercially available, nutritionally similar, dark chocolate will be consumed daily for 8 weeks Receives: Dietary Supplement: low polyphenol content chocolate bar |
| Powder Matrix - Placebo | Placebo comparator | Dietary Supplement: nutritionally similar low polyphenol cocoa powder
6g of commercially available, nutritionally similar, cocoa powder (provided as 6 x 1g gelatine capsules) will be consumed daily for 8 weeks Receives: Dietary Supplement: low polyphenol content cocoa powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function
A test battery consisting of 7 tests will be used to investigate the role of cocoa flavanols on cognitive function in the cohort.
Measured: 8 weeks
Secondary outcomes (8)
Blood Pressure
Measured: 8 weeks
Pulse Wave Analysis
Carotid to femoral Pulse Wave Velocity (PWV) and Augmentation Index (Aix) will be measured using a Vicorder.
Measured: 8 weeks
Glycated Haemoglobin (HbA1c)
Measured: 8 weeks
Weight (Kg)
To allow for BMI measurement
Measured: 8 weeks
Height (m)
To allow for BMI measurement
Measured: 8 weeks
Body Fat Percentage
Measured: 8 weeks
Energy intakes (Kj)
Measured: 8 weeks
Flavonoid intakes (mg)
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start17 Apr 2017
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Healthy AgeingStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Ashaye, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996578
- Sponsor's protocol ID
- QueenMUra
- Status last verified
- Mar 2023
- First submitted
- 12 Dec 2016
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deary IJ, Corley J, Gow AJ, Harris SE, Houlihan LM, Marioni RE, Penke L, Rafnsson SB, Starr JM. Age-associated cognitive decline. Br Med Bull. 2009;92:135-52. doi: 10.1093/bmb/ldp033.
PubMed 19776035Vauzour D. Dietary polyphenols as modulators of brain functions: biological actions and molecular mechanisms underpinning their beneficial effects. Oxid Med Cell Longev. 2012;2012:914273. doi: 10.1155/2012/914273. Epub 2012 Jun 3.
PubMed 22701758Hendrickx H, McEwen BS, Ouderaa Fv. Metabolism, mood and cognition in aging: the importance of lifestyle and dietary intervention. Neurobiol Aging. 2005 Dec;26 Suppl 1:1-5. doi: 10.1016/j.neurobiolaging.2005.10.005. Epub 2005 Nov 14.
PubMed 16290269Brown LA, Riby LM, Reay JL. Supplementing cognitive aging: a selective review of the effects of ginkgo biloba and a number of everyday nutritional substances. Exp Aging Res. 2010 Jan-Mar;36(1):105-22. doi: 10.1080/03610730903417960.
PubMed 20054730Monti JM, Moulton CJ, Cohen NJ. The role of nutrition on cognition and brain health in ageing: a targeted approach. Nutr Res Rev. 2015 Dec;28(2):167-180. doi: 10.1017/S0954422415000141.
PubMed 26650244Haque AM, Hashimoto M, Katakura M, Tanabe Y, Hara Y, Shido O. Long-term administration of green tea catechins improves spatial cognition learning ability in rats. J Nutr. 2006 Apr;136(4):1043-7. doi: 10.1093/jn/136.4.1043.
PubMed 16549472Kaur T, Pathak CM, Pandhi P, Khanduja KL. Effects of green tea extract on learning, memory, behavior and acetylcholinesterase activity in young and old male rats. Brain Cogn. 2008 Jun;67(1):25-30. doi: 10.1016/j.bandc.2007.10.003. Epub 2007 Dec 19.
PubMed 18078701Shukitt-Hale B, Bielinski DF, Lau FC, Willis LM, Carey AN, Joseph JA. The beneficial effects of berries on cognition, motor behaviour and neuronal function in ageing. Br J Nutr. 2015 Nov 28;114(10):1542-9. doi: 10.1017/S0007114515003451. Epub 2015 Sep 22.
PubMed 26392037Williams CM, El Mohsen MA, Vauzour D, Rendeiro C, Butler LT, Ellis JA, Whiteman M, Spencer JP. Blueberry-induced changes in spatial working memory correlate with changes in hippocampal CREB phosphorylation and brain-derived neurotrophic factor (BDNF) levels. Free Radic Biol Med. 2008 Aug 1;45(3):295-305. doi: 10.1016/j.freeradbiomed.2008.04.008. Epub 2008 May 5.
PubMed 18457678Shif O, Gillette K, Damkaoutis CM, Carrano C, Robbins SJ, Hoffman JR. Effects of Ginkgo biloba administered after spatial learning on water maze and radial arm maze performance in young adult rats. Pharmacol Biochem Behav. 2006 May;84(1):17-25. doi: 10.1016/j.pbb.2006.04.003. Epub 2006 Jun 5.
PubMed 16740301Bisson JF, Nejdi A, Rozan P, Hidalgo S, Lalonde R, Messaoudi M. Effects of long-term administration of a cocoa polyphenolic extract (Acticoa powder) on cognitive performances in aged rats. Br J Nutr. 2008 Jul;100(1):94-101. doi: 10.1017/S0007114507886375. Epub 2008 Jan 8.
PubMed 18179729Bishop NA, Lu T, Yankner BA. Neural mechanisms of ageing and cognitive decline. Nature. 2010 Mar 25;464(7288):529-35. doi: 10.1038/nature08983.
PubMed 20336135
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consumption of Polyphenol Rich Cocoa Products Over 8 Weeks and Its Effect on Cognitive Function in Individuals in Their 5th Decade of Life.
- ClinicalTrials.gov ID
- NCT02996578
- Acronym / sponsor ID
- QueenMUra
- Conditions
- Healthy Ageing
- Keywords
- Cognition, Cacao, Flavan-3-ols, Blood Pressure, hemoglobin A1c protein, human, Memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 19 Dec 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.
This project aims to investigate whether consumption of cocoa polyphenols has an impact on cognitive function in individuals aged 50 to 60 years of age and if such an improvement is a result of an improvement in risk factors associated with cognitive decline in ageing.
Detailed description
Healthy cognitive ageing is an important aspect of the ageing process as it involves larger numbers of people compared to those who have already been diagnosed with conditions on the dementia spectrum (Deary et al, 2009). Hence, an active effort looking at potential lifestyle factor modification interventions to help maintain cognitive well-being are warranted.
With an ageing population, the prevalence of cognitive syndromes such as Alzheimer's disease and Parkinson's disease increases (Vauzour, 2012). Nutritional interventions can play a role in successful ageing by helping to delay the onset of age-related conditions (Hendrickx, McEwen \& van der Ouderaa, 2005; Brown, Riby \& Reay, 2009; Monti, Moulton \& Cohen, 2015). Studies have investigated the potential role of polyphenols as part of a neuroprotective lifestyle. Mouse model studies have looked at varying polyphenol sources such as tea (Haque et al., 2006; Kaur et al., 2008), blueberry (Shukitt-Hale et al., 2015; Williams et al., 2008), Gingko Biloba (Shif et al., 2008) and cocoa (Bisson et al., 2008) to mention a few.
Ageing and neurodegenerative diseases are caused by neuronal death which in turn can be triggered by neurotoxins, neuroinflammation and specific genetic mutations (Bishop, Lu \& Yankner, 2010). Dietary polyphenols have been observed to provide neuroprotection against cellular alteration by modulating the neuronal function against endogenous neurotoxins and inhibition of glial induced neuroinflammation (Vauzour, 2012).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Solid Matrix - Intervention | Active comparator | Dietary Supplement: polyphenol rich chocolate barDietary Supplement: polyphenol rich chocolate bar 17.5g of commercially available dark chocolate will be consumed daily for 8 weeks |
| Powder Matrix - Intervention | Active comparator | Dietary Supplement: polyphenol rich cocoa powderDietary Supplement: polyphenol rich cocoa powder 6g of commercially available cocoa powder (provided as 6 x 1g gelatine capsules) will be consumed daily for 8 weeks |
| Solid Matrix Intervention - Placebo | Placebo comparator | Dietary Supplement: low polyphenol content chocolate barDietary Supplement: low polyphenol chocolate 17.5g of commercially available, nutritionally similar, dark chocolate will be consumed daily for 8 weeks |
| Powder Matrix - Placebo | Placebo comparator | Dietary Supplement: low polyphenol content cocoa powderDietary Supplement: nutritionally similar low polyphenol cocoa powder 6g of commercially available, nutritionally similar, cocoa powder (provided as 6 x 1g gelatine capsules) will be consumed daily for 8 weeks |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males \& Females aged 50-60years of age with normal or corrected to normal vision
- BMI cut off points of ≥18.5 to ≤29.9 kg/m2
- Waist circumference smaller than 102cm for males \& smaller than 88cm for women
- Blood pressure of ≥ 90 over 60 and ≤ 120 over 80
- MoCA test score ≥ 26
Key exclusion criteria (15 listed)
- Allergies to cocoa or any other ingredients commonly found in cocoa confectionary eg: milk, nuts, soya
- Smoker
- Women who are new or expecting mothers, maybe or are currently pregnant and/or breastfeeding
- Taking medications for chronic conditions including (but not limited to) diabetes, heart disease, hypertension
- No previous history of stroke, brain trauma and other head-related injuries
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 |
|---|---|---|
| polyphenol rich chocolate barHigh polyphenol content chocolate bar. Each participant will consume 581.4mg of polyphenols | Dietary supplement | Solid Matrix - Intervention |
| polyphenol rich cocoa powderHigh polyphenol content cocoa powder. Each participant will consume 6g containing 554mg of polyphenols | Dietary supplement | Powder Matrix - Intervention |
| low polyphenol content chocolate barLow polyphenol content matched chocolate bar. Each participant will consume 198.5mg of polyphenols | Dietary supplement | Solid Matrix Intervention - Placebo |
| low polyphenol content cocoa powderLow polyphenol content cocoa powder. Each participant will consume 6g containing 191.2mg of polyphenols | Dietary supplement | Powder Matrix - Placebo |
Primary outcome
Cognitive Function
Time frame: 8 weeks
A test battery consisting of 7 tests will be used to investigate the role of cocoa flavanols on cognitive function in the cohort.
8 secondary outcomes
Blood Pressure
Time frame: 8 weeks
Pulse Wave Analysis
Time frame: 8 weeks
Glycated Haemoglobin (HbA1c)
Time frame: 8 weeks
Weight (Kg)
Time frame: 8 weeks
Height (m)
Time frame: 8 weeks
Body Fat Percentage
Time frame: 8 weeks
Energy intakes (Kj)
Time frame: 8 weeks
Flavonoid intakes (mg)
Time frame: 8 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 28 Mar 2023.
- Background: PubMed 19776035Deary IJ, Corley J, Gow AJ, Harris SE, Houlihan LM, Marioni RE, Penke L, Rafnsson SB, Starr JM. Age-associated cognitive decline. Br Med Bull. 2009;92:135-52. doi: 10.1093/bmb/ldp033.
- Background: PubMed 22701758Vauzour D. Dietary polyphenols as modulators of brain functions: biological actions and molecular mechanisms underpinning their beneficial effects. Oxid Med Cell Longev. 2012;2012:914273. doi: 10.1155/2012/914273. Epub 2012 Jun 3.
- Background: PubMed 16290269Hendrickx H, McEwen BS, Ouderaa Fv. Metabolism, mood and cognition in aging: the importance of lifestyle and dietary intervention. Neurobiol Aging. 2005 Dec;26 Suppl 1:1-5. doi: 10.1016/j.neurobiolaging.2005.10.005. Epub 2005 Nov 14.
- Background: PubMed 20054730Brown LA, Riby LM, Reay JL. Supplementing cognitive aging: a selective review of the effects of ginkgo biloba and a number of everyday nutritional substances. Exp Aging Res. 2010 Jan-Mar;36(1):105-22. doi: 10.1080/03610730903417960.
- Background: PubMed 26650244Monti JM, Moulton CJ, Cohen NJ. The role of nutrition on cognition and brain health in ageing: a targeted approach. Nutr Res Rev. 2015 Dec;28(2):167-180. doi: 10.1017/S0954422415000141.
- Background: PubMed 16549472Haque AM, Hashimoto M, Katakura M, Tanabe Y, Hara Y, Shido O. Long-term administration of green tea catechins improves spatial cognition learning ability in rats. J Nutr. 2006 Apr;136(4):1043-7. doi: 10.1093/jn/136.4.1043.
- Background: PubMed 18078701Kaur T, Pathak CM, Pandhi P, Khanduja KL. Effects of green tea extract on learning, memory, behavior and acetylcholinesterase activity in young and old male rats. Brain Cogn. 2008 Jun;67(1):25-30. doi: 10.1016/j.bandc.2007.10.003. Epub 2007 Dec 19.
- Background: PubMed 26392037Shukitt-Hale B, Bielinski DF, Lau FC, Willis LM, Carey AN, Joseph JA. The beneficial effects of berries on cognition, motor behaviour and neuronal function in ageing. Br J Nutr. 2015 Nov 28;114(10):1542-9. doi: 10.1017/S0007114515003451. Epub 2015 Sep 22.
- Background: PubMed 18457678Williams CM, El Mohsen MA, Vauzour D, Rendeiro C, Butler LT, Ellis JA, Whiteman M, Spencer JP. Blueberry-induced changes in spatial working memory correlate with changes in hippocampal CREB phosphorylation and brain-derived neurotrophic factor (BDNF) levels. Free Radic Biol Med. 2008 Aug 1;45(3):295-305. doi: 10.1016/j.freeradbiomed.2008.04.008. Epub 2008 May 5.
- Background: PubMed 16740301Shif O, Gillette K, Damkaoutis CM, Carrano C, Robbins SJ, Hoffman JR. Effects of Ginkgo biloba administered after spatial learning on water maze and radial arm maze performance in young adult rats. Pharmacol Biochem Behav. 2006 May;84(1):17-25. doi: 10.1016/j.pbb.2006.04.003. Epub 2006 Jun 5.
- Background: PubMed 18179729Bisson JF, Nejdi A, Rozan P, Hidalgo S, Lalonde R, Messaoudi M. Effects of long-term administration of a cocoa polyphenolic extract (Acticoa powder) on cognitive performances in aged rats. Br J Nutr. 2008 Jul;100(1):94-101. doi: 10.1017/S0007114507886375. Epub 2008 Jan 8.
- Background: PubMed 20336135Bishop NA, Lu T, Yankner BA. Neural mechanisms of ageing and cognitive decline. Nature. 2010 Mar 25;464(7288):529-35. doi: 10.1038/nature08983.
- 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.
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 polyphenol rich chocolate bar, polyphenol rich cocoa powder and low polyphenol content chocolate bar in people with Healthy Ageing, run by Queen Margaret University 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 5 inclusion and 15 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 28 Mar 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 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?
Cognitive Function (time frame: 8 weeks). 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 NCT02996578, which also lists 12 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 28 Mar 2023.