Metabolic Syndrome XNCT02480673
EFFECT OF Salvia Hispanica l. (CHIA) IN THE BIOCHEMICAL METABOLIC SYNDROME COMPONENTS
A study testing Chia, Oatmeal and Normocaloric diet in people with Metabolic Syndrome X, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
The objective of this study is to evaluate the effect of the administration of 25 g of chia per day, for 90 days on the biochemical components of the metabolic syndrome in subjects with this condition Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- Chia, Oatmeal and Normocaloric diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2015to May 2016
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of metabolic syndrome according to Adult Treatment Panel - III criteria.
- Subject wishing to participate in the study by written consent.
- Instituto Mexicano del Seguro Social beneficiaries subject
- Subject who not requiring modification of medical treatment for MS in the recruitment period.
Who cannot join
- Chronic renal failure with filtration glomerular rate clearance less than 30ml / min.
- Diabetic neuropathy.
- Post menopause
- Intestinal malabsorption diseases .
- Type 2 diabetes with HbA1c > 8.5 %
- Systolic and diastolic blood pressure >140/90 mmHg.
Show all 18Show fewer
- Triglycerides > 300 mg/dL.
- LDL cholesterol >160mg/dL.
- Systemic autoimmune diseases .
- Cirrhosis or liver failure .
- Subject infected with human immunodeficiency virus or acquired immunodeficiency syndrome .
- Diagnosis of cancer with active disease.
- Subject previously undergoing bariatric surgery.
- Pregnancy or lactation.
- Alcoholism and drug addiction.
- Subject who consume high fiber dietary supplements and / or omega 3 acids.
- Subject taking anorexic drugs.
- Subject under diet for weight loss implemented by a health professional.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Mexicano Del Seguro Social Hospital de Especialidades, Centro Medico Nacional de Occidente Lic. Ignacio Garcia Tellez Unidad Medica de Alta Especialidad
Guadalajara, Jalisco, 44340
Ana E Pérez Verdin, MD, 011523336170060 ext. 31465, verdinmd@hotmail.com
Blanca M Torres Mendoza, PhD, 011523336170060 ext. 31950, bltorres1@hotmail.com
About this study
Official title: EFFECT OF Salvia Hispanica L. ( CHIA ) IN THE BIOCHEMICAL METABOLIC SYNDROME COMPONENTS IN PATIENTS IN THE NATIONAL MEDICAL CENTER WEST OF THE MEXICAN SOCIAL SECURITY INSTITUTE
The objective of this study is to evaluate the effect of the administration of 25 g of chia per day, for 90 days on the biochemical components of the metabolic syndrome in subjects with this condition
Read the detailed description
The metabolic syndrome (MS) is a cardiovascular risk factor and is present in about 20-25% of the world's adult population. Individuals with this condition have twice the risk of cardiovascular disease and die from it, compared with those who do not and 5 times more likely to develop type 2 diabetes mellitus (DM2). For this reason, it is appropriate to develop better tools for prevention and management of MS, with more emphasis on lifestyle´s changes. Chia has been studied in the past 10 years due to its high concentration of omega-3 alpha-linolenic acid (ALA) and 6 linoleic acid (LA) showing beneficial effects in some components of MS in rodents and individuals. The addition of chia to the conventional treatment of MS for the modification of metabolic disorders provides us a tool for easy incorporation into daily life, inexpensive and accessible in our environment.
- Conditions
- Metabolic Syndrome X
- Being tested
- Chia, Oatmeal, Normocaloric diet
- Keywords
- Metabolic Syndrome X, Chia, Dyslipidemia
- Medical subject headings
- Metabolic Syndrome, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChiaDietary supplement
Also called Salvia hispanica
The subject will eat 25 gr of chia in 2 oatmeal cookies at day
OatmealDietary supplement
Also called Oats
The subject will eat 2 oatmeal cookies a day containing the exactly same quantity of oats in the oatmeal cookies with chia.
Normocaloric dietBehavioural
The healthy diet plan distribution will be 50% carbohydrate, 25 % protein, 35 % fat to less than 7 % saturated fat and less than 200 mg/d cholesterol and 20-30 g of fiber.
| Study group | Role | What they receive |
|---|---|---|
| Free diet plus Chia | Experimental | This subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days without changing their diet Receives: Dietary Supplement: Chia |
| Normocaloric diet plus chia | Experimental | This subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days along with a normocaloric diet Receives: Dietary Supplement: Chia; Behavioral: Normocaloric diet |
| Normocaloric diet plus oatmeal | Active comparator | This subjects will consume 1 cookie oatmeal before breakfast and dinner for 90 days along with a normocaloric diet Receives: Dietary Supplement: Oatmeal; Behavioral: Normocaloric diet |
| Normocaloric diet | Active comparator | This subjects will only go under a normocaloric diet for 90 days Receives: Behavioral: Normocaloric diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum glucose levels
Fasting, postprandial and post challenge oral test glucose and HbA1c
Measured: 94 days (plus or minus 4 days)
Variation in lipid profile
Triglycerides, HDL-cholesterol, LDL-cholesterol and total cholesterol
Measured: 94 days (plus or minus 4 days)
Secondary outcomes (5)
Modification in insulin resistance
Serum insulin, homeostasis model assessment index
Measured: 94 days (plus or minus 4 days)
Change in systolic blood pressure
Measured: 94 days (plus or minus 4 days)
Change in diastolic blood pressure
Measured: 94 days (plus or minus 4 days)
Variation in body weight
Measured: 94 days (plus or minus 4 days)
Modification in waist circumference
Measured: 94 days (plus or minus 4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015 (estimated)
- Study completionMay 2016 (estimated)
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 Metabolic Syndrome XStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ana Elena Perez Verdin, Instituto Mexicano del Seguro Social
- Investigators
- Ana E Perez Verdin, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480673
- Sponsor's protocol ID
- R-2015-785-047
- Status last verified
- Jun 2015
- First submitted
- 22 Jun 2015
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mohd Ali N, Yeap SK, Ho WY, Beh BK, Tan SW, Tan SG. The promising future of chia, Salvia hispanica L. J Biomed Biotechnol. 2012;2012:171956. doi: 10.1155/2012/171956. Epub 2012 Nov 21.
PubMed 23251075Ayerza R Jr, Coates W. Effect of dietary alpha-linolenic fatty acid derived from chia when fed as ground seed, whole seed and oil on lipid content and fatty acid composition of rat plasma. Ann Nutr Metab. 2007;51(1):27-34. doi: 10.1159/000100818. Epub 2007 Mar 14.
PubMed 17356263Chicco AG, D'Alessandro ME, Hein GJ, Oliva ME, Lombardo YB. Dietary chia seed (Salvia hispanica L.) rich in alpha-linolenic acid improves adiposity and normalises hypertriacylglycerolaemia and insulin resistance in dyslipaemic rats. Br J Nutr. 2009 Jan;101(1):41-50. doi: 10.1017/S000711450899053X. Epub 2008 May 20.
PubMed 18492301Rossi AS, Oliva ME, Ferreira MR, Chicco A, Lombardo YB. Dietary chia seed induced changes in hepatic transcription factors and their target lipogenic and oxidative enzyme activities in dyslipidaemic insulin-resistant rats. Br J Nutr. 2013 May;109(9):1617-27. doi: 10.1017/S0007114512003558. Epub 2012 Sep 5.
PubMed 22947172Oliva ME, Ferreira MR, Chicco A, Lombardo YB. Dietary Salba (Salvia hispanica L) seed rich in alpha-linolenic acid improves adipose tissue dysfunction and the altered skeletal muscle glucose and lipid metabolism in dyslipidemic insulin-resistant rats. Prostaglandins Leukot Essent Fatty Acids. 2013 Oct;89(5):279-89. doi: 10.1016/j.plefa.2013.09.010. Epub 2013 Sep 25.
PubMed 24120122Poudyal H, Panchal SK, Waanders J, Ward L, Brown L. Lipid redistribution by alpha-linolenic acid-rich chia seed inhibits stearoyl-CoA desaturase-1 and induces cardiac and hepatic protection in diet-induced obese rats. J Nutr Biochem. 2012 Feb;23(2):153-62. doi: 10.1016/j.jnutbio.2010.11.011. Epub 2011 Mar 22.
PubMed 21429727Vuksan V, Whitham D, Sievenpiper JL, Jenkins AL, Rogovik AL, Bazinet RP, Vidgen E, Hanna A. Supplementation of conventional therapy with the novel grain Salba (Salvia hispanica L.) improves major and emerging cardiovascular risk factors in type 2 diabetes: results of a randomized controlled trial. Diabetes Care. 2007 Nov;30(11):2804-10. doi: 10.2337/dc07-1144. Epub 2007 Aug 8.
PubMed 17686832Nieman DC, Cayea EJ, Austin MD, Henson DA, McAnulty SR, Jin F. Chia seed does not promote weight loss or alter disease risk factors in overweight adults. Nutr Res. 2009 Jun;29(6):414-8. doi: 10.1016/j.nutres.2009.05.011.
PubMed 19628108Jin F, Nieman DC, Sha W, Xie G, Qiu Y, Jia W. Supplementation of milled chia seeds increases plasma ALA and EPA in postmenopausal women. Plant Foods Hum Nutr. 2012 Jun;67(2):105-10. doi: 10.1007/s11130-012-0286-0.
PubMed 22538527Vuksan V, Jenkins AL, Dias AG, Lee AS, Jovanovski E, Rogovik AL, Hanna A. Reduction in postprandial glucose excursion and prolongation of satiety: possible explanation of the long-term effects of whole grain Salba (Salvia Hispanica L.). Eur J Clin Nutr. 2010 Apr;64(4):436-8. doi: 10.1038/ejcn.2009.159. Epub 2010 Jan 20.
PubMed 20087375Ho H, Lee AS, Jovanovski E, Jenkins AL, Desouza R, Vuksan V. Effect of whole and ground Salba seeds (Salvia Hispanica L.) on postprandial glycemia in healthy volunteers: a randomized controlled, dose-response trial. Eur J Clin Nutr. 2013 Jul;67(7):786-8. doi: 10.1038/ejcn.2013.103. Epub 2013 Jun 19.
PubMed 23778782Guevara-Cruz M, Tovar AR, Aguilar-Salinas CA, Medina-Vera I, Gil-Zenteno L, Hernandez-Viveros I, Lopez-Romero P, Ordaz-Nava G, Canizales-Quinteros S, Guillen Pineda LE, Torres N. A dietary pattern including nopal, chia seed, soy protein, and oat reduces serum triglycerides and glucose intolerance in patients with metabolic syndrome. J Nutr. 2012 Jan;142(1):64-9. doi: 10.3945/jn.111.147447. Epub 2011 Nov 16.
PubMed 22090467
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF Salvia Hispanica L. ( CHIA ) IN THE BIOCHEMICAL METABOLIC SYNDROME COMPONENTS IN PATIENTS IN THE NATIONAL MEDICAL CENTER WEST OF THE MEXICAN SOCIAL SECURITY INSTITUTE
- ClinicalTrials.gov ID
- NCT02480673
- Acronym / sponsor ID
- R-2015-785-047
- Conditions
- Metabolic Syndrome X
- Keywords
- Metabolic Syndrome X, Chia, Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 24 Jun 2015 (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 objective of this study is to evaluate the effect of the administration of 25 g of chia per day, for 90 days on the biochemical components of the metabolic syndrome in subjects with this condition
Detailed description
The metabolic syndrome (MS) is a cardiovascular risk factor and is present in about 20-25% of the world's adult population. Individuals with this condition have twice the risk of cardiovascular disease and die from it, compared with those who do not and 5 times more likely to develop type 2 diabetes mellitus (DM2). For this reason, it is appropriate to develop better tools for prevention and management of MS, with more emphasis on lifestyle´s changes. Chia has been studied in the past 10 years due to its high concentration of omega-3 alpha-linolenic acid (ALA) and 6 linoleic acid (LA) showing beneficial effects in some components of MS in rodents and individuals. The addition of chia to the conventional treatment of MS for the modification of metabolic disorders provides us a tool for easy incorporation into daily life, inexpensive and accessible in our environment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Free diet plus Chia | Experimental | Dietary Supplement: ChiaThis subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days without changing their diet |
| Normocaloric diet plus chia | Experimental | Dietary Supplement: Chia, Behavioral: Normocaloric dietThis subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days along with a normocaloric diet |
| Normocaloric diet plus oatmeal | Active comparator | Dietary Supplement: Oatmeal, Behavioral: Normocaloric dietThis subjects will consume 1 cookie oatmeal before breakfast and dinner for 90 days along with a normocaloric diet |
| Normocaloric diet | Active comparator | Behavioral: Normocaloric dietThis subjects will only go under a normocaloric diet for 90 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of metabolic syndrome according to Adult Treatment Panel - III criteria.
- Subject wishing to participate in the study by written consent.
- Instituto Mexicano del Seguro Social beneficiaries subject
- Subject who not requiring modification of medical treatment for MS in the recruitment period.
Key exclusion criteria (18 listed)
- Chronic renal failure with filtration glomerular rate clearance less than 30ml / min.
- Diabetic neuropathy.
- Post menopause
- Intestinal malabsorption diseases .
- Type 2 diabetes with HbA1c > 8.5 %
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 |
|---|---|---|
| ChiaAlso: Salvia hispanicaThe subject will eat 25 gr of chia in 2 oatmeal cookies at day | Dietary supplement | Free diet plus Chia, Normocaloric diet plus chia |
| OatmealAlso: OatsThe subject will eat 2 oatmeal cookies a day containing the exactly same quantity of oats in the oatmeal cookies with chia. | Dietary supplement | Normocaloric diet plus oatmeal |
| Normocaloric dietThe healthy diet plan distribution will be 50% carbohydrate, 25 % protein, 35 % fat to less than 7 % saturated fat and less than 200 mg/d cholesterol and 20-30 g of fiber. | Behavioural | Normocaloric diet, Normocaloric diet plus chia, Normocaloric diet plus oatmeal |
Primary outcome
Change in serum glucose levels
Time frame: 94 days (plus or minus 4 days)
Fasting, postprandial and post challenge oral test glucose and HbA1c
Variation in lipid profile
Time frame: 94 days (plus or minus 4 days)
Triglycerides, HDL-cholesterol, LDL-cholesterol and total cholesterol
5 secondary outcomes
Modification in insulin resistance
Time frame: 94 days (plus or minus 4 days)
Change in systolic blood pressure
Time frame: 94 days (plus or minus 4 days)
Change in diastolic blood pressure
Time frame: 94 days (plus or minus 4 days)
Variation in body weight
Time frame: 94 days (plus or minus 4 days)
Modification in waist circumference
Time frame: 94 days (plus or minus 4 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
- Results publication: PubMed 23251075Mohd Ali N, Yeap SK, Ho WY, Beh BK, Tan SW, Tan SG. The promising future of chia, Salvia hispanica L. J Biomed Biotechnol. 2012;2012:171956. doi: 10.1155/2012/171956. Epub 2012 Nov 21.
- Results publication: PubMed 17356263Ayerza R Jr, Coates W. Effect of dietary alpha-linolenic fatty acid derived from chia when fed as ground seed, whole seed and oil on lipid content and fatty acid composition of rat plasma. Ann Nutr Metab. 2007;51(1):27-34. doi: 10.1159/000100818. Epub 2007 Mar 14.
- Results publication: PubMed 18492301Chicco AG, D'Alessandro ME, Hein GJ, Oliva ME, Lombardo YB. Dietary chia seed (Salvia hispanica L.) rich in alpha-linolenic acid improves adiposity and normalises hypertriacylglycerolaemia and insulin resistance in dyslipaemic rats. Br J Nutr. 2009 Jan;101(1):41-50. doi: 10.1017/S000711450899053X. Epub 2008 May 20.
- Results publication: PubMed 22947172Rossi AS, Oliva ME, Ferreira MR, Chicco A, Lombardo YB. Dietary chia seed induced changes in hepatic transcription factors and their target lipogenic and oxidative enzyme activities in dyslipidaemic insulin-resistant rats. Br J Nutr. 2013 May;109(9):1617-27. doi: 10.1017/S0007114512003558. Epub 2012 Sep 5.
- Results publication: PubMed 24120122Oliva ME, Ferreira MR, Chicco A, Lombardo YB. Dietary Salba (Salvia hispanica L) seed rich in alpha-linolenic acid improves adipose tissue dysfunction and the altered skeletal muscle glucose and lipid metabolism in dyslipidemic insulin-resistant rats. Prostaglandins Leukot Essent Fatty Acids. 2013 Oct;89(5):279-89. doi: 10.1016/j.plefa.2013.09.010. Epub 2013 Sep 25.
- Results publication: PubMed 21429727Poudyal H, Panchal SK, Waanders J, Ward L, Brown L. Lipid redistribution by alpha-linolenic acid-rich chia seed inhibits stearoyl-CoA desaturase-1 and induces cardiac and hepatic protection in diet-induced obese rats. J Nutr Biochem. 2012 Feb;23(2):153-62. doi: 10.1016/j.jnutbio.2010.11.011. Epub 2011 Mar 22.
- Results publication: PubMed 17686832Vuksan V, Whitham D, Sievenpiper JL, Jenkins AL, Rogovik AL, Bazinet RP, Vidgen E, Hanna A. Supplementation of conventional therapy with the novel grain Salba (Salvia hispanica L.) improves major and emerging cardiovascular risk factors in type 2 diabetes: results of a randomized controlled trial. Diabetes Care. 2007 Nov;30(11):2804-10. doi: 10.2337/dc07-1144. Epub 2007 Aug 8.
- Results publication: PubMed 19628108Nieman DC, Cayea EJ, Austin MD, Henson DA, McAnulty SR, Jin F. Chia seed does not promote weight loss or alter disease risk factors in overweight adults. Nutr Res. 2009 Jun;29(6):414-8. doi: 10.1016/j.nutres.2009.05.011.
- Results publication: PubMed 22538527Jin F, Nieman DC, Sha W, Xie G, Qiu Y, Jia W. Supplementation of milled chia seeds increases plasma ALA and EPA in postmenopausal women. Plant Foods Hum Nutr. 2012 Jun;67(2):105-10. doi: 10.1007/s11130-012-0286-0.
- Results publication: PubMed 20087375Vuksan V, Jenkins AL, Dias AG, Lee AS, Jovanovski E, Rogovik AL, Hanna A. Reduction in postprandial glucose excursion and prolongation of satiety: possible explanation of the long-term effects of whole grain Salba (Salvia Hispanica L.). Eur J Clin Nutr. 2010 Apr;64(4):436-8. doi: 10.1038/ejcn.2009.159. Epub 2010 Jan 20.
- Results publication: PubMed 23778782Ho H, Lee AS, Jovanovski E, Jenkins AL, Desouza R, Vuksan V. Effect of whole and ground Salba seeds (Salvia Hispanica L.) on postprandial glycemia in healthy volunteers: a randomized controlled, dose-response trial. Eur J Clin Nutr. 2013 Jul;67(7):786-8. doi: 10.1038/ejcn.2013.103. Epub 2013 Jun 19.
- Results publication: PubMed 22090467Guevara-Cruz M, Tovar AR, Aguilar-Salinas CA, Medina-Vera I, Gil-Zenteno L, Hernandez-Viveros I, Lopez-Romero P, Ordaz-Nava G, Canizales-Quinteros S, Guillen Pineda LE, Torres N. A dietary pattern including nopal, chia seed, soy protein, and oat reduces serum triglycerides and glucose intolerance in patients with metabolic syndrome. J Nutr. 2012 Jan;142(1):64-9. doi: 10.3945/jn.111.147447. Epub 2011 Nov 16.
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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.
Ana E Perez Verdin, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chia, Oatmeal and Normocaloric diet in people with Metabolic Syndrome X, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 18 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 26 Jun 2015. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana E Perez Verdin, MD (011523336170060 ext. 31465, verdinmd@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum glucose levels (time frame: 94 days (plus or minus 4 days)). 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 NCT02480673, 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 26 Jun 2015.