ObesityPhase 2MetSProbNCT01978691
The Effect of a Bifidobacterium and Polydextrose on Body Fat Mass
A Phase 2 study testing Bifidobacterium animalis ssp. lactis 420 and Polydextrose in people with Obesity and Hyperglycemia, run by Danisco at 4 sites in Finland.
Trial summary
Obesity is a major problem worldwide, and it is related to abnormalities in glucose and lipid metabolism. The purpose of this study is to investigate the effect of a dietary supplement containing probiotic (Bifidobacterium animalis ssp. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hyperglycemia, Insulin Resistance
- What is being tested?
- Bifidobacterium animalis ssp. lactis 420 and Polydextrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 4 sitesFinland
- Study dates
- Nov 2013to May 2015
- Phase
- Phase 2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 28.0-34.9
- Waist to hip ratio: males ≥0.88, females ≥0.83
- Age 18-65 years
- Signed informed consent
- Available for all study visits and phone calls
- Follows a regular diet that is in agreement with the national dietary recommendations
Who cannot join
- Diagnosed type 1 or type 2 diabetes (i.e. fasting plasma glucose ≥ 7 mmol/l and HbA1C ≥ 6.5%)
- Use of medication for diabetes, dyslipidemia or hypertension
- Use of laxatives or fiber supplements in the past 6 weeks
- History of diagnosed coronary heart disease, other significant cardiovascular disease or artificial heart valve
- History of chronic active inflammatory disorders
- History of bariatric surgery
Show all 23Show fewer
- Use of anti-obesity drugs in the last 3 months
- Use of anticoagulants
- Regular use of non-steroidal anti-inflammatory drugs, systemic or inhaled corticosteroids, or systemic immunomodulatory drugs
- Recent (last 2 months) or ongoing antibiotic use
- Immunosuppression or ongoing therapy causing immunosuppression
- Use of probiotics more than once a week during the previous 6 weeks
- Use of vitamin D supplementation:
- > 50 - <100 µg/day during the previous 2 weeks
- ≥ 100 - <150 µg/day during the previous 2 months
- ≥150 µg/day or above during the previous 12 months
- Active or recent (last 3 months) participation in a weight loss program or weight change (increase or loss) of 3 kg during the past 3 months
- Pregnant or planning pregnancy within 6 months or breastfeeding women
- Participation in a clinical trial with an investigational product or drug within 60 days prior to screening
- Likeliness to be noncompliant with the protocol
- Drug or alcohol abuse
- Allergy to any of the ingredients used in the study
- Other reasons that, in the opinion of the Investigator makes the subject unsuitable for enrolment
Trial locations and contacts
4 sites in 1 country.
Finland4 sites
VL-Medi
Helsinki, 00101
Kerava healthcare center
Kerava, 04200
FinnMedi Oy
Tampere, 33520
CRST - Clinical Research Services Turku
Turku, 20521
About this study
Official title: The Effect of Separate or Combined Supplementation of Probiotic (Bifidobacterium Lactis B420) and Polydextrose on Body Fat Mass
Obesity is a major problem worldwide, and it is related to abnormalities in glucose and lipid metabolism. The purpose of this study is to investigate the effect of a dietary supplement containing probiotic (Bifidobacterium animalis ssp. lactis 420) and/or prebiotic (Litesse) on change in body fat mass in a double-blind, randomized, placebo-controlled intervention trial. The supplement is ingested once per day for the duration of six months, and participants will attend a follow-up visit one month after the end of the intervention. The study will enroll 232 participants (58 per study arm) in four research centers in southern Finland.
Read the detailed description
Obesity is a major problem worldwide, and it is related to abnormalities in glucose and lipid metabolism. Preclinical studies have shown that weight gain and insulin resistance may be prevented by oral administration of the probiotic Bifidobacterium animalis ssp. lactis 420. Furthermore, the prebiotic polydextrose has shown efficacy on satiety in clinical settings. The purpose of this study is to investigate the effects of these products, individually and combined, on change in body fat mass in a double-blind, randomized, placebo-controlled intervention trial. The study is conducted at four research clinics in southern Finland. The supplement is provided in a sachet, mixed into a fruit smoothie and ingested once per day for the duration of six months. One month from the end of the intervention participants will attend a follow-up visit. The study will enroll 232 participants, who will be randomized into blocks using a computerized procedure.
After the screening visit, there will be seven study visits (once per month) and one follow-up visit. Visits at months 0, 2, 4, 6 and follow-up are clinic visits, and visits at months 1, 3 and 5 are phone contacts to check compliance and any adverse events.
Clinic visits include the following measurements and samples:
- weight
- blood pressure and heart rate
- blood samples
- returning of food diaries (only during intervention)
- returning of exercise questionnaires and food choice questionnaires (only beginning and end of treatment)
- returning of fecal samples, taken at home by participant
- DXA for body composition analysis
- hip and waist circumference
- brief physical examination (only beginning and end of treatment)
- recording of adverse events and concomitant medication
For compliance check, unused sachets are returned to the clinic and counted. At the follow-up visit participants will receive guidance on exercise and a healthy diet.
The primary variable of this study is relative change from baseline to end-of-treatment in body fat mass. Comparisons between each of the active groups against the placebo group will be performed if the global P-value is significant. Secondary variables will be analyzed in a similar fashion. The relative and absolute changes in body fat mass will also be analyzed. To explore the mechanism of potential treatment benefits, post-hoc responder analyses may optionally be performed. Also, correlations between the response variables may be examined in exploratory analyses. Post-hoc analyses may be conducted to compare e.g. different time points or to analyze differences from end-of-treatment to follow-up.
- Conditions
- Obesity, Hyperglycemia, Insulin Resistance
- Being tested
- Bifidobacterium animalis ssp. lactis 420, Polydextrose, Placebo
- Keywords
- Obesity, Blood glucose, Waist circumference, Lipid metabolism, Probiotics, Prebiotics, Dietary supplements, Endotoxemia
- Medical subject headings
- Obesity, Hyperglycemia, Insulin Resistance, Endotoxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium animalis ssp. lactis 420Dietary supplement
Also called B420
Studied as a probiotic bacteria
PolydextroseDietary supplement
Also called Litesse, Litesse Ultra
Studied as a prebiotic
PlaceboOther
Also called Microcrystalline cellulose
Control
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Bifidobacterium animalis ssp. lactis 420 (10^10 colony-forming units (CFU)/day in 12 g of microcrystalline cellulose), once per day for six months in a sachet mixed into a smoothie drink Receives: Dietary Supplement: Bifidobacterium animalis ssp. lactis 420 |
| Prebiotic | Active comparator | Polydextrose, 12 g once per day for six months in a sachet mixed into a smoothie drink Receives: Dietary Supplement: Polydextrose |
| Synbiotic | Active comparator | B. lactis 420 (10^10 CFU/day) in 12 g of polydextrose, once per day for six months in a sachet to be mixed into a smoothie drink Receives: Dietary Supplement: Bifidobacterium animalis ssp. lactis 420; Dietary Supplement: Polydextrose |
| Control | Placebo comparator | 12 g of microcrystalline cellulose once per day for six months in a sachet to be mixed into a smoothie drink Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in body fat mass from baseline to end-of-treatment (6 months)
Measured with dual-energy x-ray absorptiometry (DXA)
Measured: From baseline to end of intervention (6 months)
Secondary outcomes (18)
Change in weight (absolute and relative)
Measured: Months 0, 2, 4, 6 and 7 (follow-up)
Change in BMI (absolute and relative)
Measured: Months 0, 2, 4, 6 and 7 (follow-up)
Change in lean body mass
Total, and in individual regions of the body
Measured: Months 0, 2, 4, 6 and 7 (follow-up)
Hip Change in waist and/or hip circumference (absolute and relative)
Measured: Months 0, 2, 4, 6 and 7 (follow-up)
Change in glycated haemoglobin (HbA1c) in blood
Measured: Months 0, 2, 4, 6 and 7 (follow-up)
Change in fasting glucose levels
Measured: Months 0, 2, 4, 6 and 7 (follow-up)
Change in fasting insulin levels
Measured: Months 0, 2, 4, 6 and 7 (follow-up)
Change in insulin resistance
As determined by Homeostasis Model Assessment (HOMA)
Measured: Months 0, 2, 4, 6 and 7 (follow-up)
Change in inflammatory markers
Including high-sensitive C-reactive protein (CRP), Interleukin (IL)-6, Tumor necrosis factor (TNF)-alpha, IL-1beta, cortisol, adiponectin, leptin
Measured: Months 0, 2, 4, 6 and 7 (follow-up)
Change in lipopolysaccharide (LPS) concentration and soluble CD14 (sCD14)
Measured: Months 0, 2, 4, 6 and 7 (follow-up)
Change in LPS/sCD14 ratio
Measured: Months 0, 2, 4, 6 and 7 (follow-up)
Change in blood lipids
Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Measured: Months 0, 2, 4, 6 and 7 (follow-up)
Change in blood pressure
Measured: Months 0, 2, 4, 6 and 7 (follow-up)
Change in aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) and gamma-glutamyltransferase
Measured: Months 0, 2, 4, 6 and 7 (follow-up)
Change in energy, fat and fiber intake
Measured: Months 0, 2, 4, 6 and 7 (follow-up)
Absolute change in body fat mass
Measured: Months 0, 2, 4, 6 and 7 (follow-up)
Analytical description of faecal microbiota
Measured: Months 0, 2, 4, 6 and 7 (follow-up)
Body fat mass in individual regions of the body
Measured: Months 0, 2, 4, 6 and 7 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aila Rissanen, MD, Principal investigator, HYKS-instituutti Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978691
- Sponsor's protocol ID
- SMR-2782
- Acronym
- MetSProb
- Status last verified
- Feb 2016
- First submitted
- 1 Nov 2013
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Amar J, Chabo C, Waget A, Klopp P, Vachoux C, Bermudez-Humaran LG, Smirnova N, Berge M, Sulpice T, Lahtinen S, Ouwehand A, Langella P, Rautonen N, Sansonetti PJ, Burcelin R. Intestinal mucosal adherence and translocation of commensal bacteria at the early onset of type 2 diabetes: molecular mechanisms and probiotic treatment. EMBO Mol Med. 2011 Sep;3(9):559-72. doi: 10.1002/emmm.201100159. Epub 2011 Aug 3.
PubMed 21735552Hibberd AA, Yde CC, Ziegler ML, Honore AH, Saarinen MT, Lahtinen S, Stahl B, Jensen HM, Stenman LK. Probiotic or synbiotic alters the gut microbiota and metabolism in a randomised controlled trial of weight management in overweight adults. Benef Microbes. 2019 Mar 13;10(2):121-135. doi: 10.3920/BM2018.0028. Epub 2018 Dec 10.
PubMed 30525950Stenman LK, Lehtinen MJ, Meland N, Christensen JE, Yeung N, Saarinen MT, Courtney M, Burcelin R, Lahdeaho ML, Linros J, Apter D, Scheinin M, Kloster Smerud H, Rissanen A, Lahtinen S. Probiotic With or Without Fiber Controls Body Fat Mass, Associated With Serum Zonulin, in Overweight and Obese Adults-Randomized Controlled Trial. EBioMedicine. 2016 Nov;13:190-200. doi: 10.1016/j.ebiom.2016.10.036. Epub 2016 Oct 26.
PubMed 27810310
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Separate or Combined Supplementation of Probiotic (Bifidobacterium Lactis B420) and Polydextrose on Body Fat Mass
- ClinicalTrials.gov ID
- NCT01978691
- Acronym / sponsor ID
- MetSProb / SMR-2782
- Conditions
- Obesity, Hyperglycemia, Insulin Resistance
- Keywords
- Obesity, Blood glucose, Waist circumference, Lipid metabolism, Probiotics, Prebiotics, Dietary supplements, Endotoxemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 7 Nov 2013 (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.
Obesity is a major problem worldwide, and it is related to abnormalities in glucose and lipid metabolism. The purpose of this study is to investigate the effect of a dietary supplement containing probiotic (Bifidobacterium animalis ssp. lactis 420) and/or prebiotic (Litesse) on change in body fat mass in a double-blind, randomized, placebo-controlled intervention trial. The supplement is ingested once per day for the duration of six months, and participants will attend a follow-up visit one month after the end of the intervention. The study will enroll 232 participants (58 per study arm) in four research centers in southern Finland.
Detailed description
Obesity is a major problem worldwide, and it is related to abnormalities in glucose and lipid metabolism. Preclinical studies have shown that weight gain and insulin resistance may be prevented by oral administration of the probiotic Bifidobacterium animalis ssp. lactis 420. Furthermore, the prebiotic polydextrose has shown efficacy on satiety in clinical settings. The purpose of this study is to investigate the effects of these products, individually and combined, on change in body fat mass in a double-blind, randomized, placebo-controlled intervention trial. The study is conducted at four research clinics in southern Finland. The supplement is provided in a sachet, mixed into a fruit smoothie and ingested once per day for the duration of six months. One month from the end of the intervention participants will attend a follow-up visit. The study will enroll 232 participants, who will be randomized into blocks using a computerized procedure.
After the screening visit, there will be seven study visits (once per month) and one follow-up visit. Visits at months 0, 2, 4, 6 and follow-up are clinic visits, and visits at months 1, 3 and 5 are phone contacts to check compliance and any adverse events.
Clinic visits include the following measurements and samples:
- weight
- blood pressure and heart rate
- blood samples
- returning of food diaries (only during intervention)
- returning of exercise questionnaires and food choice questionnaires (only beginning and end of treatment)
- returning of fecal samples, taken at home by participant
- DXA for body composition analysis
- hip and waist circumference
- brief physical examination (only beginning and end of treatment)
- recording of adverse events and concomitant medication
For compliance check, unused sachets are returned to the clinic and counted. At the follow-up visit participants will receive guidance on exercise and a healthy diet.
The primary variable of this study is relative change from baseline to end-of-treatment in body fat mass. Comparisons between each of the active groups against the placebo group will be performed if the global P-value is significant. Secondary variables will be analyzed in a similar fashion. The relative and absolute changes in body fat mass will also be analyzed. To explore the mechanism of potential treatment benefits, post-hoc responder analyses may optionally be performed. Also, correlations between the response variables may be examined in exploratory analyses. Post-hoc analyses may be conducted to compare e.g. different time points or to analyze differences from end-of-treatment to follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: Bifidobacterium animalis ssp. lactis 420Bifidobacterium animalis ssp. lactis 420 (10^10 colony-forming units (CFU)/day in 12 g of microcrystalline cellulose), once per day for six months in a sachet mixed into a smoothie drink |
| Prebiotic | Active comparator | Dietary Supplement: PolydextrosePolydextrose, 12 g once per day for six months in a sachet mixed into a smoothie drink |
| Synbiotic | Active comparator | Dietary Supplement: Bifidobacterium animalis ssp. lactis 420, Dietary Supplement: PolydextroseB. lactis 420 (10^10 CFU/day) in 12 g of polydextrose, once per day for six months in a sachet to be mixed into a smoothie drink |
| Control | Placebo comparator | Other: Placebo12 g of microcrystalline cellulose once per day for six months in a sachet to be mixed into a smoothie drink |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI between 28.0-34.9
- Waist to hip ratio: males ≥0.88, females ≥0.83
- Age 18-65 years
- Signed informed consent
- Available for all study visits and phone calls
Key exclusion criteria (23 listed)
- Diagnosed type 1 or type 2 diabetes (i.e. fasting plasma glucose ≥ 7 mmol/l and HbA1C ≥ 6.5%)
- Use of medication for diabetes, dyslipidemia or hypertension
- Use of laxatives or fiber supplements in the past 6 weeks
- History of diagnosed coronary heart disease, other significant cardiovascular disease or artificial heart valve
- History of chronic active inflammatory disorders
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 |
|---|---|---|
| Bifidobacterium animalis ssp. lactis 420Also: B420Studied as a probiotic bacteria | Dietary supplement | Probiotic, Synbiotic |
| PolydextroseAlso: Litesse, Litesse UltraStudied as a prebiotic | Dietary supplement | Prebiotic, Synbiotic |
| PlaceboAlso: Microcrystalline celluloseControl | Other | Control |
Primary outcome
Difference in body fat mass from baseline to end-of-treatment (6 months)
Time frame: From baseline to end of intervention (6 months)
Measured with dual-energy x-ray absorptiometry (DXA)
18 secondary outcomes
Change in weight (absolute and relative)
Time frame: Months 0, 2, 4, 6 and 7 (follow-up)
Change in BMI (absolute and relative)
Time frame: Months 0, 2, 4, 6 and 7 (follow-up)
Change in lean body mass
Time frame: Months 0, 2, 4, 6 and 7 (follow-up)
Hip Change in waist and/or hip circumference (absolute and relative)
Time frame: Months 0, 2, 4, 6 and 7 (follow-up)
Change in glycated haemoglobin (HbA1c) in blood
Time frame: Months 0, 2, 4, 6 and 7 (follow-up)
Change in fasting glucose levels
Time frame: Months 0, 2, 4, 6 and 7 (follow-up)
Change in fasting insulin levels
Time frame: Months 0, 2, 4, 6 and 7 (follow-up)
Change in insulin resistance
Time frame: Months 0, 2, 4, 6 and 7 (follow-up)
Change in inflammatory markers
Time frame: Months 0, 2, 4, 6 and 7 (follow-up)
Change in lipopolysaccharide (LPS) concentration and soluble CD14 (sCD14)
Time frame: Months 0, 2, 4, 6 and 7 (follow-up)
Change in LPS/sCD14 ratio
Time frame: Months 0, 2, 4, 6 and 7 (follow-up)
Change in blood lipids
Time frame: Months 0, 2, 4, 6 and 7 (follow-up)
Change in blood pressure
Time frame: Months 0, 2, 4, 6 and 7 (follow-up)
Change in aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) and gamma-glutamyltransferase
Time frame: Months 0, 2, 4, 6 and 7 (follow-up)
Change in energy, fat and fiber intake
Time frame: Months 0, 2, 4, 6 and 7 (follow-up)
Absolute change in body fat mass
Time frame: Months 0, 2, 4, 6 and 7 (follow-up)
Analytical description of faecal microbiota
Time frame: Months 0, 2, 4, 6 and 7 (follow-up)
Body fat mass in individual regions of the body
Time frame: Months 0, 2, 4, 6 and 7 (follow-up)
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 2 Feb 2016.
- Background: PubMed 21735552Amar J, Chabo C, Waget A, Klopp P, Vachoux C, Bermudez-Humaran LG, Smirnova N, Berge M, Sulpice T, Lahtinen S, Ouwehand A, Langella P, Rautonen N, Sansonetti PJ, Burcelin R. Intestinal mucosal adherence and translocation of commensal bacteria at the early onset of type 2 diabetes: molecular mechanisms and probiotic treatment. EMBO Mol Med. 2011 Sep;3(9):559-72. doi: 10.1002/emmm.201100159. Epub 2011 Aug 3.
- Derived from this study: PubMed 30525950Hibberd AA, Yde CC, Ziegler ML, Honore AH, Saarinen MT, Lahtinen S, Stahl B, Jensen HM, Stenman LK. Probiotic or synbiotic alters the gut microbiota and metabolism in a randomised controlled trial of weight management in overweight adults. Benef Microbes. 2019 Mar 13;10(2):121-135. doi: 10.3920/BM2018.0028. Epub 2018 Dec 10.
- Derived from this study: PubMed 27810310Stenman LK, Lehtinen MJ, Meland N, Christensen JE, Yeung N, Saarinen MT, Courtney M, Burcelin R, Lahdeaho ML, Linros J, Apter D, Scheinin M, Kloster Smerud H, Rissanen A, Lahtinen S. Probiotic With or Without Fiber Controls Body Fat Mass, Associated With Serum Zonulin, in Overweight and Obese Adults-Randomized Controlled Trial. EBioMedicine. 2016 Nov;13:190-200. doi: 10.1016/j.ebiom.2016.10.036. Epub 2016 Oct 26.
- Individual participant dataSharing planned: Undecided
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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.
Aila Rissanen, MD principal investigator
HYKS-instituutti Oy
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bifidobacterium animalis ssp. lactis 420 and Polydextrose in people with Obesity and Hyperglycemia, run by Danisco at 4 sites in Finland.
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 6 inclusion and 23 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 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Difference in body fat mass from baseline to end-of-treatment (6 months) (time frame: From baseline to end of intervention (6 months)). 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 NCT01978691, which also lists 3 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 2 Feb 2016.