Gut MicrobiotaNCT02151825
Effect of a Synbiotic on the Gut Microbiota and Adiposity-related Markers in Healthy Overweight Subjects
A study testing Synbiotic in people with Gut Microbiota and Adiposity, run by Texas State University, San Marcos at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of a synbiotic (ProSynbiotic) on the gut microbiota composition, body composition and adiposity-related genes and metabolic markers in healthy overweight adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota, Adiposity
- What is being tested?
- Synbiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Oct 2012
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-64
- BMI of 25-34.9 and/or a waist circumference >35 inches for women and >40 inches for men
- Generally healthy except for overweight or moderately obese
- A signed consent form
- Passed a screening questionnaire and willingness to comply with study procedures
- Lipid levels, fasting glucose, liver function and complete blood counts within the normal reference ranges as measured in a screening blood sample
Who cannot join
- Persons on a weight-loss regimen
- Antibiotic use (< 3 months before the study)
- Regular probiotic, prebiotic or synbiotic use (< 1 month before the study)
- Regular use of anti-inflammatory drugs, weight-loss medications or supplements (< 1 month prior to the study)
- Personal history of cardiovascular disease, hypertension, cancer, type 1 or type 2 diabetes and inflammatory gastrointestinal disorders such as Crohn's disease or colitis
- Smoking
Show all 10Show fewer
- Consumption of >2 units of alcohol per day
- Pregnancy or lactation
- Irregular periods, menopause or hormone replacement therapy
- Over 300 minutes of exercise per week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on the Influence of a Synbiotic Formulation (ProSynbiotic) on Gut Microbiota Composition, Adiposity and Selected Markers of Cardiometabolic Health in Overweight or Moderately Obese Individuals
The purpose of this study is to investigate the effects of a synbiotic (ProSynbiotic) on the gut microbiota composition, body composition and adiposity-related genes and metabolic markers in healthy overweight adult subjects.
Read the detailed description
This is a parallel, double-blind, randomized, placebo controlled trial to determine the effects of a synbiotic formulation (ProSynbiotic) containing 4 billion CFU of a probiotic blend of Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5, Lactobacillus casei 431 and Saccharomyces boulardii, along with 1 g of the prebiotic inulin and 100 mg of galactooligosaccharide (GOS) on the gut microbiota composition, body composition, expression of genes mediating dietary energy harvest and adiposity, and on adiposity-related metabolic markers in healthy free-living overweight or moderately obese subjects. The duration of the study is 18 weeks, including a 2-week run-in period before randomization of subjects into the synbiotic or placebo group, a 12-week intervention period, and a 4-week follow-up after the end of the intervention. During the intervention period, subjects will be instructed to take 3 capsules of either synbiotic or placebo per day and maintain their habitual diet and physical activity. They will also be asked to document any unusual symptoms or side effects as well as keep a bowel diary. Diet and physical activity will be monitored via 24-h dietary recalls and the global physical activity questionnaire respectively. Changes in the gut microbiota composition will be determined by measuring bacterial population levels in stool sampled collected at baseline, 6 weeks, 12 weeks and the follow up time point. Body composition will be measured using the BOD POD at baseline, 6 weeks, and 12 weeks. Gene expression levels will be assessed at baseline and 12 weeks in colonocytes (isolated from stool samples) and PBMCs (isolated from blood samples) by qPCR. Metabolic markers will be measured at baseline and 12-weeks in plasma or serum using the respective biochemical- or immuno-assays.
- Conditions
- Gut Microbiota, Adiposity
- Being tested
- Synbiotic, Placebo
- Keywords
- Gut microbiota, Probiotics, Prebiotics, Synbiotic, Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5, Lactobacillus casei 431, Inulin, GOS, Body Weight, Overweight, Adiposity, Obesity, ANGPTL4
- Medical subject headings
- Obesity, Body Weight, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynbioticDietary supplement
Also called Prosynbiotic
3 capsules per day containing 4 billion CFU of Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5, Lactobacillus casei 431 and Saccharomyces boulardii in combination with prebiotics Inulin (1 g) and Galactooligosaccharides (100 mg)
PlaceboOther
3 capsules of Maltodextrin per day
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic | Experimental | 3 capsules per day containing 4 billion CFU of Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5, Lactobacillus casei 431 and Saccharomyces boulardii in combination with prebiotics Inulin (1 g) and Galactooligosaccharides (100 mg) Receives: Dietary Supplement: Synbiotic |
| Placebo | Placebo comparator | 3 capsules of Maltodextrin per day Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes to the gut microbiota
The primary objective of this study is to determine the effect of a synbiotic formulation called ProSynbiotic (administered at 3 capsules/day) containing 4 billion CFU of a probiotic blend of Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5, Lactobacillus casei 431 and Saccharomyces boulardii, along with 1 g of the prebiotic inulin and 100 mg of galactooligosaccharide (GOS) on the gut microbiota of healthy overweight adult subjects when compared to a placebo of maltodextrin. Changes in the gut microbiota will be determined by measuring specific bacterial population levels in the subjects' fecal samples, using 16S rRNA targeted oligonucleotide probes and fluorescence in situ hybridisation.
Measured: 0-weeks (Baseline), 6-weeks (midpoint of intervention), 12-weeks (end of intervention) and 16-weeks (4-weeks after end of intervention)
Secondary outcomes (3)
Body composition
The effect of Prosynbiotic on the subjects' body composition will be evaluated by BOD POD assessment carried out at baseline, 6-weeks and 12-weeks.
Measured: Baseline, 6-weeks and 12-weeks.
Expression of genes mediating dietary energy harvest and adiposity
This will be achieved by measuring the gene expression levels of ANGPTL4, PPAR-γ and GPR41/43 in colonocytes isolated from stool and that of ANGPTL4, PPAR-γ, NF-kB, IL-6 and TNF-α in PBMCs isolated from blood collected from the subjects at baseline and 12-weeks.
Measured: Baseline and 12-weeks
Adiposity-related metabolic markers
This will be achieved by measuring TNF-α, adiponectin, total cholesterol, LDL-C, HDL-C, triglycerides and glucose levels in fasting blood samples collected from the study subjects at baseline and 12-weeks.
Measured: Baseline and 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas State University, San Marcos
- Sponsor type
- University, hospital or other
- Collaborators
- Standard Process Inc.
- Responsible party
- Principal investigator, Vatsala Maitin, Texas State University, San Marcos
- Investigators
- Vatsala Maitin, PhD, Principal investigator, Texas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151825
- Sponsor's protocol ID
- 2011F7611
- Other IDs
- 110021
- Status last verified
- May 2014
- First submitted
- 28 May 2014
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Influence of a Synbiotic Formulation (ProSynbiotic) on Gut Microbiota Composition, Adiposity and Selected Markers of Cardiometabolic Health in Overweight or Moderately Obese Individuals
- ClinicalTrials.gov ID
- NCT02151825
- Acronym / sponsor ID
- 2011F7611
- Conditions
- Gut Microbiota, Adiposity
- Keywords
- Gut microbiota, Probiotics, Prebiotics, Synbiotic, Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5, Lactobacillus casei 431, Inulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Texas State University, San MarcosUniversity, hospital or other
- Collaborators
- Standard Process Inc.
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 30 May 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 purpose of this study is to investigate the effects of a synbiotic (ProSynbiotic) on the gut microbiota composition, body composition and adiposity-related genes and metabolic markers in healthy overweight adult subjects.
Detailed description
This is a parallel, double-blind, randomized, placebo controlled trial to determine the effects of a synbiotic formulation (ProSynbiotic) containing 4 billion CFU of a probiotic blend of Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5, Lactobacillus casei 431 and Saccharomyces boulardii, along with 1 g of the prebiotic inulin and 100 mg of galactooligosaccharide (GOS) on the gut microbiota composition, body composition, expression of genes mediating dietary energy harvest and adiposity, and on adiposity-related metabolic markers in healthy free-living overweight or moderately obese subjects. The duration of the study is 18 weeks, including a 2-week run-in period before randomization of subjects into the synbiotic or placebo group, a 12-week intervention period, and a 4-week follow-up after the end of the intervention. During the intervention period, subjects will be instructed to take 3 capsules of either synbiotic or placebo per day and maintain their habitual diet and physical activity. They will also be asked to document any unusual symptoms or side effects as well as keep a bowel diary. Diet and physical activity will be monitored via 24-h dietary recalls and the global physical activity questionnaire respectively. Changes in the gut microbiota composition will be determined by measuring bacterial population levels in stool sampled collected at baseline, 6 weeks, 12 weeks and the follow up time point. Body composition will be measured using the BOD POD at baseline, 6 weeks, and 12 weeks. Gene expression levels will be assessed at baseline and 12 weeks in colonocytes (isolated from stool samples) and PBMCs (isolated from blood samples) by qPCR. Metabolic markers will be measured at baseline and 12-weeks in plasma or serum using the respective biochemical- or immuno-assays.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotic | Experimental | Dietary Supplement: Synbiotic3 capsules per day containing 4 billion CFU of Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5, Lactobacillus casei 431 and Saccharomyces boulardii in combination with prebiotics Inulin (1 g) and Galactooligosaccharides (100 mg) |
| Placebo | Placebo comparator | Other: Placebo3 capsules of Maltodextrin per day |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18-64
- BMI of 25-34.9 and/or a waist circumference >35 inches for women and >40 inches for men
- Generally healthy except for overweight or moderately obese
- A signed consent form
- Passed a screening questionnaire and willingness to comply with study procedures
Key exclusion criteria (10 listed)
- Persons on a weight-loss regimen
- Antibiotic use (< 3 months before the study)
- Regular probiotic, prebiotic or synbiotic use (< 1 month before the study)
- Regular use of anti-inflammatory drugs, weight-loss medications or supplements (< 1 month prior to the study)
- Personal history of cardiovascular disease, hypertension, cancer, type 1 or type 2 diabetes and inflammatory gastrointestinal disorders such as Crohn's disease or colitis
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 |
|---|---|---|
| SynbioticAlso: Prosynbiotic3 capsules per day containing 4 billion CFU of Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5, Lactobacillus casei 431 and Saccharomyces boulardii in combination with prebiotics Inulin (1 g) and Galactooligosaccharides (100 mg) | Dietary supplement | Synbiotic |
| Placebo3 capsules of Maltodextrin per day | Other | Placebo |
Primary outcome
Changes to the gut microbiota
Time frame: 0-weeks (Baseline), 6-weeks (midpoint of intervention), 12-weeks (end of intervention) and 16-weeks (4-weeks after end of intervention)
The primary objective of this study is to determine the effect of a synbiotic formulation called ProSynbiotic (administered at 3 capsules/day) containing 4 billion CFU of a probiotic blend of Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5, Lactobacillus casei 431 and Saccharomyces boulardii, along with 1 g of the prebiotic inulin and 100 mg of galactooligosaccharide (GOS) on the gut microbiota of healthy overweight adult subjects when compared to a placebo of maltodextrin. Changes in the gut microbiota will be determined by measuring specific bacterial population levels in the subjects' fecal samples, using 16S rRNA targeted oligonucleotide probes and fluorescence in situ hybridisation.
3 secondary outcomes
Body composition
Time frame: Baseline, 6-weeks and 12-weeks.
Expression of genes mediating dietary energy harvest and adiposity
Time frame: Baseline and 12-weeks
Adiposity-related metabolic markers
Time frame: Baseline and 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 30 May 2014.
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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.
Vatsala Maitin, PhD principal investigator
Texas State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic in people with Gut Microbiota and Adiposity, run by Texas State University, San Marcos at 1 site in United States.
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 10 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 30 May 2014. 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 States. 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?
Changes to the gut microbiota (time frame: 0-weeks (Baseline), 6-weeks (midpoint of intervention), 12-weeks (end of intervention) and 16-weeks (4-weeks after end of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2014.