Bariatric SurgeryNCT03517345
The Metabolic Effects of Prebiotic Supplementation After Roux-en-Y Gastric Bypass Surgery
A study testing Prebiotic in people with Bariatric Surgery, run by Istanbul University.
Trial summary
In this study, it is aimed to evaluate whether the addition of prebiotics to patients' post-operative diets increases Roux-en-Y Gastric Bypass surgery effects. Half of the participants were randomized prebiotic with conventional yogurt, while the other half were randomized only conventional yogurt as a snack Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- Prebiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 22 Apr 2013to 10 Feb 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI >40kg/m2; perform of other types of bariatric surgery except gastric bypass (i.e. sleeve gastrectomy, adjustable gastric band)
Who cannot join
- Administration of antibiotics (other than 1 g ampicillin-sulbactam one hour before surgery), the presence of chronic gastrointestinal, liver or kidney diseases and malignancy.
About this study
Official title: Investigating the Effects of Prebiotic Supplementation on Metabolic Effects of Roux-en-Y Gastric Bypass Surgery: A Prospective Randomized Trial
In this study, it is aimed to evaluate whether the addition of prebiotics to patients' post-operative diets increases Roux-en-Y Gastric Bypass surgery effects. Half of the participants were randomized prebiotic with conventional yogurt, while the other half were randomized only conventional yogurt as a snack
Read the detailed description
Following bariatric surgery, positive alterations are observed in gut microbiota, intestinal peptides, and inflammatory cytokines. Previous studies demonstrate that prebiotic use alone in a tolerable dose (which is 10 g/day) among obese, overweight, or diabetic individuals accelerated the weight loss by reducing hunger and food intake. Furthermore, it could also contribute to the improvement of glucose homeostasis by increase postprandial PYY and GLP-1 levels. Prebiotics feeds healthy intestinal bacteria and enhances their positive effects. The present positive effects appear with SCFAs that stimulates PYY and GLP-1 release and produced by fermentation of prebiotics by bacteria. From this point forth, it was hypothesized that post-operative pre-probiotic usage may enhance the effects of Roux-en-Y Gastric Bypass (RYGB). In addition, administration of pre-probiotics following RYGB may be considered as a simple and cheap treatment support, especially for protecting patients with poor medicine compliance against nutritional deficiencies, as well as for diabetic patients whose glucose regulations deteriorate in the long term, and for those who regain weight.
With the result that the effects of prebiotic supplementation on metabolic results of RYGB surgery in this prospective, randomized, controlled study with a duration of 24 weeks were tested.
- Conditions
- Bariatric Surgery
- Being tested
- Prebiotic, Control
- Keywords
- Bariatric surgery, Prebiotics, gut microbiota, GLP-1, PYY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticDietary supplement
Prebiotic (Inulin+Oligofructose) consumed as 10 g/d in yogurt (200 g/d)
ControlDietary supplement
The only yogurt consumed as 200 g/d without prebiotic.
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic group | Experimental | Given a prebiotic product (inulin + oligofructose; 5 g) mixed with conventional yogurt (100 g) which given as snack, twice a day. Receives: Dietary Supplement: Prebiotic |
| Control group | Experimental | Given conventional yogurt (100 g) which given as snack, twice a day. Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma GLP-1 levels changes
Change in baseline GLP-1 levels (pM) at 6th month. Measured by plasma samples.
Measured: 6 months
Plasma PYY levels changes
Change in baseline PYY levels (pg/ml) at 6th month. Measured by plasma samples.
Measured: 6 months
Secondary outcomes (1)
Appetite regulation
Change in baseline appetite at 6th month. Subjective appetite assessed with visual analog scales
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start22 Apr 2013
- Primary completion5 Dec 2014
- Study completion10 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Turker, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517345
- Sponsor's protocol ID
- 31806
- Status last verified
- Apr 2018
- First submitted
- 14 Feb 2018
- Last updated
- 7 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Calikoglu F, Barbaros U, Uzum AK, Tutuncu Y, Satman I. The Metabolic Effects of Pre-probiotic Supplementation After Roux-en-Y Gastric Bypass (RYGB) Surgery: a Prospective, Randomized Controlled Study. Obes Surg. 2021 Jan;31(1):215-223. doi: 10.1007/s11695-020-04894-6. Epub 2020 Aug 15.
PubMed 32803709
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Prebiotic Supplementation on Metabolic Effects of Roux-en-Y Gastric Bypass Surgery: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03517345
- Acronym / sponsor ID
- 31806
- Conditions
- Bariatric Surgery
- Keywords
- Bariatric surgery, Prebiotics, gut microbiota, GLP-1, PYY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 22 Apr 2013 (actual)
- Primary completion
- 5 Dec 2014 (actual)
- Study completion
- 10 Feb 2015 (actual)
- First posted
- 7 May 2018 (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.
In this study, it is aimed to evaluate whether the addition of prebiotics to patients' post-operative diets increases Roux-en-Y Gastric Bypass surgery effects. Half of the participants were randomized prebiotic with conventional yogurt, while the other half were randomized only conventional yogurt as a snack
Detailed description
Following bariatric surgery, positive alterations are observed in gut microbiota, intestinal peptides, and inflammatory cytokines. Previous studies demonstrate that prebiotic use alone in a tolerable dose (which is 10 g/day) among obese, overweight, or diabetic individuals accelerated the weight loss by reducing hunger and food intake. Furthermore, it could also contribute to the improvement of glucose homeostasis by increase postprandial PYY and GLP-1 levels. Prebiotics feeds healthy intestinal bacteria and enhances their positive effects. The present positive effects appear with SCFAs that stimulates PYY and GLP-1 release and produced by fermentation of prebiotics by bacteria. From this point forth, it was hypothesized that post-operative pre-probiotic usage may enhance the effects of Roux-en-Y Gastric Bypass (RYGB). In addition, administration of pre-probiotics following RYGB may be considered as a simple and cheap treatment support, especially for protecting patients with poor medicine compliance against nutritional deficiencies, as well as for diabetic patients whose glucose regulations deteriorate in the long term, and for those who regain weight.
With the result that the effects of prebiotic supplementation on metabolic results of RYGB surgery in this prospective, randomized, controlled study with a duration of 24 weeks were tested.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prebiotic group | Experimental | Dietary Supplement: PrebioticGiven a prebiotic product (inulin + oligofructose; 5 g) mixed with conventional yogurt (100 g) which given as snack, twice a day. |
| Control group | Experimental | Dietary Supplement: ControlGiven conventional yogurt (100 g) which given as snack, twice a day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI >40kg/m2; perform of other types of bariatric surgery except gastric bypass (i.e. sleeve gastrectomy, adjustable gastric band)
Key exclusion criteria (1 listed)
- Administration of antibiotics (other than 1 g ampicillin-sulbactam one hour before surgery), the presence of chronic gastrointestinal, liver or kidney diseases and malignancy.
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 |
|---|---|---|
| PrebioticPrebiotic (Inulin+Oligofructose) consumed as 10 g/d in yogurt (200 g/d) | Dietary supplement | Prebiotic group |
| ControlThe only yogurt consumed as 200 g/d without prebiotic. | Dietary supplement | Control group |
Primary outcome
Plasma GLP-1 levels changes
Time frame: 6 months
Change in baseline GLP-1 levels (pM) at 6th month. Measured by plasma samples.
Plasma PYY levels changes
Time frame: 6 months
Change in baseline PYY levels (pg/ml) at 6th month. Measured by plasma samples.
1 secondary outcome
Appetite regulation
Time frame: 6 months
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 7 May 2018.
- Derived from this study: PubMed 32803709Calikoglu F, Barbaros U, Uzum AK, Tutuncu Y, Satman I. The Metabolic Effects of Pre-probiotic Supplementation After Roux-en-Y Gastric Bypass (RYGB) Surgery: a Prospective, Randomized Controlled Study. Obes Surg. 2021 Jan;31(1):215-223. doi: 10.1007/s11695-020-04894-6. Epub 2020 Aug 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic in people with Bariatric Surgery, run by Istanbul University.
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 1 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 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Plasma GLP-1 levels changes (time frame: 6 months). 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 NCT03517345, which also lists 1 linked publication.
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 7 May 2018.