ObesityNCT03123510
Effect of a Synbiotic Supplement on a High-protein Diet
A study testing Bifidobacterium spp plus bimuno- galacto-oligosaccharides in people with Obesity, run by South Dakota State University at 1 site in United States.
Trial summary
The objective of the trial is to study how a synbiotic treatment will affect weight loss and management in individuals enrolled in weight loss diet Profile®. The investigators propose to follow up 2 cohorts of Profile® subjects during 6 months. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Bifidobacterium spp plus bimuno- galacto-oligosaccharides
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 1 Nov 2017
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any individual aged 18-80 years participating in the Profile weight loss/management diet
Who cannot join
- Pregnant
- Requires special diets or dietary regimens
- On long term antibiotic therapy
- Diagnosed with gastrointestinal diseases (Irritable Bowel syndrome, Crohn's disease or Colitis)
- Immune compromised
- Have cancer
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
South Dakota State University
Brookings, South Dakota, 57007
Eduardo Huarte, PhD, 605-688-6324, eduardo.huarte@sdstate.edu
About this study
Official title: Role of Synbiotics on a Weight Loss Intervention Program: Effect on Microbiome
The objective of the trial is to study how a synbiotic treatment will affect weight loss and management in individuals enrolled in weight loss diet Profile®. The investigators propose to follow up 2 cohorts of Profile® subjects during 6 months. One group will receive a synbiotic treatment supplement (Bifidobacterium spp plus bimuno- galacto-oligosaccharides (B-GOS)) while the other group will receive placebo capsules. Anthropomorphic and metabolic analysis will be performed by-monthly. Fecal samples will be obtained before and after the dietary intervention and samples will be sequenced trough next generation DNA sequencing to analyze the gut microbiota. Because dietary interventions with high protein and low glycemic index have been shown to be effective in reducing weight, but has also been linked to potential colon harm due to increased fermentation of undigested protein on the colon, the investigators expect supplementation of Profile® with a synbiotic product will lead to an increased overall wellbeing without compromising weight management.
Read the detailed description
The investigators intend to recruit 40 new Profile® members and to randomly divide them into 2 groups; Group A will follow the conventional coaching and diet plan, while group B will also receive a daily dose of the synbiotic treatment (group A will receive a placebo supplement similar in appearance and caloric content to the synbiotic treatment). Volunteers will be followed for 6 months, and weight loss, waist circumference, BMI and glucose and cholesterol levels will be assessed monthly. Dual-energy x-ray absorptiometry (DXA) will be used to analyze body composition at the beginning and end of the dietary interventions. Fecal samples will be obtained at the beginning and the end of the study. Because both our pre- and probiotic supplements have been reported to increase the concentration of satiating bacteria-derived metabolites, we expect that the individuals on the group B (synbiotic supplement) will experience a higher weight loss as well as more significant drops in glucose and cholesterol levels. Because synbiotic treatments have been reported to facilitate GI passage, the investigators expect volunteers in group B will also report improved bowels movements and general wellbeing.
- Conditions
- Obesity
- Being tested
- Bifidobacterium spp plus bimuno- galacto-oligosaccharides, Placebo
- Keywords
- probiotics, prebiotics, synbiotics, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium spp plus bimuno- galacto-oligosaccharidesDietary supplement
Volunteers will be asked to take one probiotic capsule and one prebiotic satchel daily.
PlaceboDietary supplement
Volunteers will be asked to take one placebo capsule and one placebo satchel daily.
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic supplement | Experimental | Bifidobacterium spp plus bimuno- galacto-oligosaccharides Receives: Dietary Supplement: Bifidobacterium spp plus bimuno- galacto-oligosaccharides |
| placebo | Placebo comparator | sugar pills Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Gut microbiota associated to the synbiotic treatment
Stools samples will be collected and analyzed before and after the intervention and compared between groups
Measured: 3 months
Secondary outcomes (4)
Changes in weight associated to the synbiotic treatment
Weight (kg) will be monitored every 6 weeks
Measured: 3 months
Changes in glucose levels associated to the synbiotic treatment
A1C (Glycated hemoglobin) levels will be monitored every 6 weeks
Measured: 3 months
Changes in body density associated to the synbiotic treatment
body density . A DXA body scan will be performed at the beginning and end of the intervention
Measured: 3 months
Changes in waist circumference associated to the synbiotic treatment
Waist circumference (cm) will be measured every 6 weeks
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 Mar 2017
- Primary completion31 Jul 2017 (estimated)
- Study completion1 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- One group will receive a synbiotic supplement and the other placebo capsules.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Dakota State University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanford Health
- Responsible party
- Principal investigator, Eduardo Huarte, South Dakota State University
- Investigators
- eduardo Huarte, PhD, Principal investigator, South Dakota State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123510
- Sponsor's protocol ID
- 1604005
- Status last verified
- Apr 2017
- First submitted
- 29 Mar 2017
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Result of the study will be made available to the scientific community trough manuscript publication. Each participant will be assigned a code to maintain patient confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Synbiotics on a Weight Loss Intervention Program: Effect on Microbiome
- ClinicalTrials.gov ID
- NCT03123510
- Acronym / sponsor ID
- 1604005
- Conditions
- Obesity
- Keywords
- probiotics, prebiotics, synbiotics, obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- South Dakota State UniversityUniversity, hospital or other
- Collaborators
- Sanford Health
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Jul 2017 (estimated)
- Study completion
- 1 Nov 2017 (estimated)
- First posted
- 21 Apr 2017 (actual)
- 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 the trial is to study how a synbiotic treatment will affect weight loss and management in individuals enrolled in weight loss diet Profile®. The investigators propose to follow up 2 cohorts of Profile® subjects during 6 months. One group will receive a synbiotic treatment supplement (Bifidobacterium spp plus bimuno- galacto-oligosaccharides (B-GOS)) while the other group will receive placebo capsules. Anthropomorphic and metabolic analysis will be performed by-monthly. Fecal samples will be obtained before and after the dietary intervention and samples will be sequenced trough next generation DNA sequencing to analyze the gut microbiota. Because dietary interventions with high protein and low glycemic index have been shown to be effective in reducing weight, but has also been linked to potential colon harm due to increased fermentation of undigested protein on the colon, the investigators expect supplementation of Profile® with a synbiotic product will lead to an increased overall wellbeing without compromising weight management.
Detailed description
The investigators intend to recruit 40 new Profile® members and to randomly divide them into 2 groups; Group A will follow the conventional coaching and diet plan, while group B will also receive a daily dose of the synbiotic treatment (group A will receive a placebo supplement similar in appearance and caloric content to the synbiotic treatment). Volunteers will be followed for 6 months, and weight loss, waist circumference, BMI and glucose and cholesterol levels will be assessed monthly. Dual-energy x-ray absorptiometry (DXA) will be used to analyze body composition at the beginning and end of the dietary interventions. Fecal samples will be obtained at the beginning and the end of the study. Because both our pre- and probiotic supplements have been reported to increase the concentration of satiating bacteria-derived metabolites, we expect that the individuals on the group B (synbiotic supplement) will experience a higher weight loss as well as more significant drops in glucose and cholesterol levels. Because synbiotic treatments have been reported to facilitate GI passage, the investigators expect volunteers in group B will also report improved bowels movements and general wellbeing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- One group will receive a synbiotic supplement and the other placebo capsules.
| Arm | Type | Receives |
|---|---|---|
| Synbiotic supplement | Experimental | Dietary Supplement: Bifidobacterium spp plus bimuno- galacto-oligosaccharidesBifidobacterium spp plus bimuno- galacto-oligosaccharides |
| placebo | Placebo comparator | Dietary Supplement: Placebosugar pills |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any individual aged 18-80 years participating in the Profile weight loss/management diet
Key exclusion criteria (6 listed)
- Pregnant
- Requires special diets or dietary regimens
- On long term antibiotic therapy
- Diagnosed with gastrointestinal diseases (Irritable Bowel syndrome, Crohn's disease or Colitis)
- Immune compromised
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 spp plus bimuno- galacto-oligosaccharidesVolunteers will be asked to take one probiotic capsule and one prebiotic satchel daily. | Dietary supplement | Synbiotic supplement |
| PlaceboVolunteers will be asked to take one placebo capsule and one placebo satchel daily. | Dietary supplement | placebo |
Primary outcome
Changes in Gut microbiota associated to the synbiotic treatment
Time frame: 3 months
Stools samples will be collected and analyzed before and after the intervention and compared between groups
4 secondary outcomes
Changes in weight associated to the synbiotic treatment
Time frame: 3 months
Changes in glucose levels associated to the synbiotic treatment
Time frame: 3 months
Changes in body density associated to the synbiotic treatment
Time frame: 3 months
Changes in waist circumference associated to the synbiotic treatment
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Individual participant dataSharing planned: Yes. Result of the study will be made available to the scientific community trough manuscript publication. Each participant will be assigned a code to maintain patient confidentiality.
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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.
eduardo Huarte, PhD principal investigator
South Dakota 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 Bifidobacterium spp plus bimuno- galacto-oligosaccharides in people with Obesity, run by South Dakota State University 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 1 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: status not confirmed, as of the sponsor's last update on 21 Apr 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact eduardo huarte, PhD (6056886324, eduardo.huarte@sdstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Gut microbiota associated to the synbiotic treatment (time frame: 3 months). 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 21 Apr 2017.