OBESITYSFLABPASTANCT02236533
Healthy Effects of an Innovative Probiotic Pasta
A study testing whole grain pasta in people with OBESITY and INFLAMMATION, run by University of Parma at 2 sites in Italy.
Trial summary
The aim of the project was the evaluation of the antioxidant and anti-inflammatory effects of a whole grain pasta, enriched in barley β-glucans and fortified with strains of Bacillus coagulans, versus a control wheat pasta on healthy volunteers, using a parallel randomized controlled trial. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- OBESITY, INFLAMMATION, DYSLIPIDEMIA
- What is being tested?
- whole grain pasta
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesItaly
- Study dates
- Mar 2014to Mar 2015
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight / Obesity
- Lower consumers of fruit and vegetables
Who cannot join
- Antibiotic treatment within 3 months prior the pasta feeding
- Chronic diseases
- Surgeries
- Consumer of whole grain products
- Dieting
- Pregnant or lactating
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
University of Parma - Department of Food Sciences
Parma, PR, 43124
University of Parma
Parma, 43124
About this study
The aim of the project was the evaluation of the antioxidant and anti-inflammatory effects of a whole grain pasta, enriched in barley β-glucans and fortified with strains of Bacillus coagulans, versus a control wheat pasta on healthy volunteers, using a parallel randomized controlled trial.
Read the detailed description
Epidemiological evidences indicate that consumption of whole grains products is associated to a decreased risk for common chronic diseases, as cardiovascular diseases, diabetes, obesity, hypertension and metabolic syndrome. In the present study a whole grain pasta was supplemented with prebiotics and probiotics 'ad hoc' formulated. In detail, pasta was industrially developed after the identification of particular cultivars of wheat and barley, rich in carotenoids, β-glucans (2.6 g/100g pasta), not soluble fibers and antioxidants. Further, pasta was supplemented with spores of Bacillus coagulans, a putative probiotic microorganism, belonging to Lactobacillus family. It is well demonstrated the ability of this microorganism to survive to technological processes and to upper gastro-intesinal tract, in order to exert beneficial effects in the lower gut, as anti-microbial activity, increasing immunological defences as well as improvements in intestinal regularity. Conversely, the control pasta was made from the same cultivar of grain and by the same technological process, but without any supplementation.
In this parallel randomized controlled one arm trial, 40 healthy volunteers were randomly allocated for the consumption of the two kind of pasta once a day, for 12 weeks. At the beginning of the study and every 4 weeks, subjects were asked to provide blood, urine and feces for the evaluation of:
- blood inflammation markers;
- blood lipid and carbohydrate profile;
- blood and urine markers of cardiovascular risk;
- feces profile of microbiota and detection of markers for the healthiness of the gut.
In addition, volunteers filled in different questionnaires regarding their dietary habits, the physical activity and the gut healthiness.
- Conditions
- OBESITY, INFLAMMATION, DYSLIPIDEMIA, CONSTIPATION
- Being tested
- whole grain pasta
- Medical subject headings
- Obesity, Inflammation, Dyslipidemias, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole grain pastaDietary supplement
Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control pasta | Placebo comparator | Volunteers were fed with control pasta, without B-glucans and spores of B. coagulans once a day for 12 weeks. Receives: Dietary Supplement: whole grain pasta |
| Probiotic Whole Grain Pasta | Experimental | Volunteers were fed with probiotic fortified pasta, including B-glucans and spores of B. coagulans once a day for 12 weeks. Receives: Dietary Supplement: whole grain pasta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of plasma lipids
Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol; Measure of plasma concentrations (µg/mL) of Non Esterified Fatty Acids (NEFA), Esterified Fatty Acids (EFA) and Short Chain Fatty Acids (SCFA).
Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered.
Measured: 12 weeks
Variation of fecal microbiota composition
By FISH (colony-forming unit, CFU/g).
Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered.
Measured: 12 weeks
Variation of antioxidant activity on fecal waters
Measure of fecal waters FRAP (µmol/L) and TEAC (µmol/L) concentrations.
Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered.
Measured: 12 weeks
Secondary outcomes (5)
Variation of body weight
Measure of body weight (kg).
Measured: 12 weeks
Variation of serum inflammatory marker concentration
Measure of serum IL-2, IL-4, IL-5, IL-6, IL-10, IL-12, IFN-γ,TNF-α, PAI-1, Ghrelin, Leptin, Visfatin, Resistin concentrations (pg/mL).
Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered.
Measured: 12 weeks
Variation of blood pressure
Measure of blood pressure (mmHg).
Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered.
Measured: 12 weeks
Variation of body circumferences
Measure of waist and hip circumferences (mm).
Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered.
Measured: 12 weeks
Variation of urine antioxidant marker
Measurement of betaine in urine (mmol/L).
Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for OBESITYStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Collaborators
- Universita di Verona
- Responsible party
- Principal investigator, Nicoletta Pellegrini, PhD, University of Parma
- Investigators
- Nicoletta Pellegrini, Professor, Principal investigator, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236533
- Sponsor's protocol ID
- SFLAB14
- Acronym
- SFLABPASTA
- Status last verified
- Oct 2018
- First submitted
- 26 Jul 2014
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Andersson A, Tengblad S, Karlstrom B, Kamal-Eldin A, Landberg R, Basu S, Aman P, Vessby B. Whole-grain foods do not affect insulin sensitivity or markers of lipid peroxidation and inflammation in healthy, moderately overweight subjects. J Nutr. 2007 Jun;137(6):1401-7. doi: 10.1093/jn/137.6.1401.
PubMed 17513398Behall KM, Scholfield DJ, Hallfrisch J. Diets containing barley significantly reduce lipids in mildly hypercholesterolemic men and women. Am J Clin Nutr. 2004 Nov;80(5):1185-93. doi: 10.1093/ajcn/80.5.1185.
PubMed 15531664Behall KM, Scholfield DJ, Hallfrisch J. Whole-grain diets reduce blood pressure in mildly hypercholesterolemic men and women. J Am Diet Assoc. 2006 Sep;106(9):1445-9. doi: 10.1016/j.jada.2006.06.010.
PubMed 16963350Bird AR, Vuaran MS, King RA, Noakes M, Keogh J, Morell MK, Topping DL. Wholegrain foods made from a novel high-amylose barley variety (Himalaya 292) improve indices of bowel health in human subjects. Br J Nutr. 2008 May;99(5):1032-40. doi: 10.1017/S000711450783902X. Epub 2007 Oct 8.
PubMed 17919346Brouns F, Hemery Y, Price R, Anson NM. Wheat aleurone: separation, composition, health aspects, and potential food use. Crit Rev Food Sci Nutr. 2012;52(6):553-68. doi: 10.1080/10408398.2011.589540.
PubMed 22452734Brownlee IA, Moore C, Chatfield M, Richardson DP, Ashby P, Kuznesof SA, Jebb SA, Seal CJ. Markers of cardiovascular risk are not changed by increased whole-grain intake: the WHOLEheart study, a randomised, controlled dietary intervention. Br J Nutr. 2010 Jul;104(1):125-34. doi: 10.1017/S0007114510000644. Epub 2010 Mar 23.
PubMed 20307353Costabile A, Klinder A, Fava F, Napolitano A, Fogliano V, Leonard C, Gibson GR, Tuohy KM. Whole-grain wheat breakfast cereal has a prebiotic effect on the human gut microbiota: a double-blind, placebo-controlled, crossover study. Br J Nutr. 2008 Jan;99(1):110-20. doi: 10.1017/S0007114507793923. Epub 2007 Aug 29.
PubMed 17761020de Munter JS, Hu FB, Spiegelman D, Franz M, van Dam RM. Whole grain, bran, and germ intake and risk of type 2 diabetes: a prospective cohort study and systematic review. PLoS Med. 2007 Aug;4(8):e261. doi: 10.1371/journal.pmed.0040261.
PubMed 17760498Dolin BJ. Effects of a proprietary Bacillus coagulans preparation on symptoms of diarrhea-predominant irritable bowel syndrome. Methods Find Exp Clin Pharmacol. 2009 Dec;31(10):655-9. doi: 10.1358/mf.2009.31.10.1441078.
PubMed 20140275Endres JR, Clewell A, Jade KA, Farber T, Hauswirth J, Schauss AG. Safety assessment of a proprietary preparation of a novel Probiotic, Bacillus coagulans, as a food ingredient. Food Chem Toxicol. 2009 Jun;47(6):1231-8. doi: 10.1016/j.fct.2009.02.018. Epub 2009 Feb 25.
PubMed 19248815Endres JR, Qureshi I, Farber T, Hauswirth J, Hirka G, Pasics I, Schauss AG. One-year chronic oral toxicity with combined reproduction toxicity study of a novel probiotic, Bacillus coagulans, as a food ingredient. Food Chem Toxicol. 2011 May;49(5):1174-82. doi: 10.1016/j.fct.2011.02.012. Epub 2011 Feb 19.
PubMed 21338652Grasten SM, Juntunen KS, Poutanen KS, Gylling HK, Miettinen TA, Mykkanen HM. Rye bread improves bowel function and decreases the concentrations of some compounds that are putative colon cancer risk markers in middle-aged women and men. J Nutr. 2000 Sep;130(9):2215-21. doi: 10.1093/jn/130.9.2215.
PubMed 10958815Honda H, Gibson GR, Farmer S, Keller D, McCartney AL. Use of a continuous culture fermentation system to investigate the effect of GanedenBC30 (Bacillus coagulans GBI-30, 6086) supplementation on pathogen survival in the human gut microbiota. Anaerobe. 2011 Feb;17(1):36-42. doi: 10.1016/j.anaerobe.2010.12.006. Epub 2010 Dec 30.
PubMed 21195203Hun L. Bacillus coagulans significantly improved abdominal pain and bloating in patients with IBS. Postgrad Med. 2009 Mar;121(2):119-24. doi: 10.3810/pgm.2009.03.1984.
PubMed 19332970Kalman DS, Schwartz HI, Alvarez P, Feldman S, Pezzullo JC, Krieger DR. A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus coagulans-based product on functional intestinal gas symptoms. BMC Gastroenterol. 2009 Nov 18;9:85. doi: 10.1186/1471-230X-9-85.
PubMed 19922649
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Effects of an Innovative Probiotic Pasta
- ClinicalTrials.gov ID
- NCT02236533
- Acronym / sponsor ID
- SFLABPASTA / SFLAB14
- Conditions
- OBESITY, INFLAMMATION, DYSLIPIDEMIA, CONSTIPATION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Collaborators
- Universita di Verona
- Study start
- Mar 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 10 Sep 2014 (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 project was the evaluation of the antioxidant and anti-inflammatory effects of a whole grain pasta, enriched in barley β-glucans and fortified with strains of Bacillus coagulans, versus a control wheat pasta on healthy volunteers, using a parallel randomized controlled trial.
Detailed description
Epidemiological evidences indicate that consumption of whole grains products is associated to a decreased risk for common chronic diseases, as cardiovascular diseases, diabetes, obesity, hypertension and metabolic syndrome. In the present study a whole grain pasta was supplemented with prebiotics and probiotics 'ad hoc' formulated. In detail, pasta was industrially developed after the identification of particular cultivars of wheat and barley, rich in carotenoids, β-glucans (2.6 g/100g pasta), not soluble fibers and antioxidants. Further, pasta was supplemented with spores of Bacillus coagulans, a putative probiotic microorganism, belonging to Lactobacillus family. It is well demonstrated the ability of this microorganism to survive to technological processes and to upper gastro-intesinal tract, in order to exert beneficial effects in the lower gut, as anti-microbial activity, increasing immunological defences as well as improvements in intestinal regularity. Conversely, the control pasta was made from the same cultivar of grain and by the same technological process, but without any supplementation.
In this parallel randomized controlled one arm trial, 40 healthy volunteers were randomly allocated for the consumption of the two kind of pasta once a day, for 12 weeks. At the beginning of the study and every 4 weeks, subjects were asked to provide blood, urine and feces for the evaluation of:
- blood inflammation markers;
- blood lipid and carbohydrate profile;
- blood and urine markers of cardiovascular risk;
- feces profile of microbiota and detection of markers for the healthiness of the gut.
In addition, volunteers filled in different questionnaires regarding their dietary habits, the physical activity and the gut healthiness.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control pasta | Placebo comparator | Dietary Supplement: whole grain pastaVolunteers were fed with control pasta, without B-glucans and spores of B. coagulans once a day for 12 weeks. |
| Probiotic Whole Grain Pasta | Experimental | Dietary Supplement: whole grain pastaVolunteers were fed with probiotic fortified pasta, including B-glucans and spores of B. coagulans once a day for 12 weeks. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Overweight / Obesity
- Lower consumers of fruit and vegetables
Key exclusion criteria (6 listed)
- Antibiotic treatment within 3 months prior the pasta feeding
- Chronic diseases
- Surgeries
- Consumer of whole grain products
- Dieting
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 |
|---|---|---|
| whole grain pastaVolunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks. | Dietary supplement | Control pasta, Probiotic Whole Grain Pasta |
Primary outcome
Variation of plasma lipids
Time frame: 12 weeks
Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol; Measure of plasma concentrations (µg/mL) of Non Esterified Fatty Acids (NEFA), Esterified Fatty Acids (EFA) and Short Chain Fatty Acids (SCFA). Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered.
Variation of fecal microbiota composition
Time frame: 12 weeks
By FISH (colony-forming unit, CFU/g). Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered.
Variation of antioxidant activity on fecal waters
Time frame: 12 weeks
Measure of fecal waters FRAP (µmol/L) and TEAC (µmol/L) concentrations. Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered.
5 secondary outcomes
Variation of body weight
Time frame: 12 weeks
Variation of serum inflammatory marker concentration
Time frame: 12 weeks
Variation of blood pressure
Time frame: 12 weeks
Variation of body circumferences
Time frame: 12 weeks
Variation of urine antioxidant marker
Time frame: 12 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 1 Nov 2018.
- Background: PubMed 17513398Andersson A, Tengblad S, Karlstrom B, Kamal-Eldin A, Landberg R, Basu S, Aman P, Vessby B. Whole-grain foods do not affect insulin sensitivity or markers of lipid peroxidation and inflammation in healthy, moderately overweight subjects. J Nutr. 2007 Jun;137(6):1401-7. doi: 10.1093/jn/137.6.1401.
- Background: PubMed 15531664Behall KM, Scholfield DJ, Hallfrisch J. Diets containing barley significantly reduce lipids in mildly hypercholesterolemic men and women. Am J Clin Nutr. 2004 Nov;80(5):1185-93. doi: 10.1093/ajcn/80.5.1185.
- Background: PubMed 16963350Behall KM, Scholfield DJ, Hallfrisch J. Whole-grain diets reduce blood pressure in mildly hypercholesterolemic men and women. J Am Diet Assoc. 2006 Sep;106(9):1445-9. doi: 10.1016/j.jada.2006.06.010.
- Background: PubMed 17919346Bird AR, Vuaran MS, King RA, Noakes M, Keogh J, Morell MK, Topping DL. Wholegrain foods made from a novel high-amylose barley variety (Himalaya 292) improve indices of bowel health in human subjects. Br J Nutr. 2008 May;99(5):1032-40. doi: 10.1017/S000711450783902X. Epub 2007 Oct 8.
- Background: PubMed 22452734Brouns F, Hemery Y, Price R, Anson NM. Wheat aleurone: separation, composition, health aspects, and potential food use. Crit Rev Food Sci Nutr. 2012;52(6):553-68. doi: 10.1080/10408398.2011.589540.
- Background: PubMed 20307353Brownlee IA, Moore C, Chatfield M, Richardson DP, Ashby P, Kuznesof SA, Jebb SA, Seal CJ. Markers of cardiovascular risk are not changed by increased whole-grain intake: the WHOLEheart study, a randomised, controlled dietary intervention. Br J Nutr. 2010 Jul;104(1):125-34. doi: 10.1017/S0007114510000644. Epub 2010 Mar 23.
- Background: PubMed 17761020Costabile A, Klinder A, Fava F, Napolitano A, Fogliano V, Leonard C, Gibson GR, Tuohy KM. Whole-grain wheat breakfast cereal has a prebiotic effect on the human gut microbiota: a double-blind, placebo-controlled, crossover study. Br J Nutr. 2008 Jan;99(1):110-20. doi: 10.1017/S0007114507793923. Epub 2007 Aug 29.
- Background: PubMed 17760498de Munter JS, Hu FB, Spiegelman D, Franz M, van Dam RM. Whole grain, bran, and germ intake and risk of type 2 diabetes: a prospective cohort study and systematic review. PLoS Med. 2007 Aug;4(8):e261. doi: 10.1371/journal.pmed.0040261.
- Background: PubMed 20140275Dolin BJ. Effects of a proprietary Bacillus coagulans preparation on symptoms of diarrhea-predominant irritable bowel syndrome. Methods Find Exp Clin Pharmacol. 2009 Dec;31(10):655-9. doi: 10.1358/mf.2009.31.10.1441078.
- Background: PubMed 19248815Endres JR, Clewell A, Jade KA, Farber T, Hauswirth J, Schauss AG. Safety assessment of a proprietary preparation of a novel Probiotic, Bacillus coagulans, as a food ingredient. Food Chem Toxicol. 2009 Jun;47(6):1231-8. doi: 10.1016/j.fct.2009.02.018. Epub 2009 Feb 25.
- Background: PubMed 21338652Endres JR, Qureshi I, Farber T, Hauswirth J, Hirka G, Pasics I, Schauss AG. One-year chronic oral toxicity with combined reproduction toxicity study of a novel probiotic, Bacillus coagulans, as a food ingredient. Food Chem Toxicol. 2011 May;49(5):1174-82. doi: 10.1016/j.fct.2011.02.012. Epub 2011 Feb 19.
- Background: PubMed 10958815Grasten SM, Juntunen KS, Poutanen KS, Gylling HK, Miettinen TA, Mykkanen HM. Rye bread improves bowel function and decreases the concentrations of some compounds that are putative colon cancer risk markers in middle-aged women and men. J Nutr. 2000 Sep;130(9):2215-21. doi: 10.1093/jn/130.9.2215.
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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.
Nicoletta Pellegrini, Professor principal investigator
University of Parma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole grain pasta in people with OBESITY and INFLAMMATION, run by University of Parma at 2 sites in Italy.
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 2 inclusion and 6 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 1 Nov 2018. 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 Italy. 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?
Variation of plasma lipids (time frame: 12 weeks). The study lists 3 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 NCT02236533, which also lists 37 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 1 Nov 2018.