The Metabolic Effects of Prebiotic Supplementation After Roux-en-Y Gastric Bypass Surgery
Investigating the Effects of Prebiotic Supplementation on Metabolic Effects of Roux-en-Y Gastric Bypass Surgery: A Prospective Randomized Trial
1 other identifier
interventional
32
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2013
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2015
CompletedFirst Submitted
Initial submission to the registry
February 14, 2018
CompletedFirst Posted
Study publicly available on registry
May 7, 2018
CompletedMay 7, 2018
April 1, 2018
1.6 years
February 14, 2018
April 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Plasma GLP-1 levels changes
Change in baseline GLP-1 levels (pM) at 6th month. Measured by plasma samples.
6 months
Plasma PYY levels changes
Change in baseline PYY levels (pg/ml) at 6th month. Measured by plasma samples.
6 months
Secondary Outcomes (1)
Appetite regulation
6 months
Other Outcomes (6)
weight changes
6 months
fat mass changes
6 months
fat free mass changes
6 months
- +3 more other outcomes
Study Arms (2)
Prebiotic group
EXPERIMENTALGiven a prebiotic product (inulin + oligofructose; 5 g) mixed with conventional yogurt (100 g) which given as snack, twice a day.
Control group
EXPERIMENTALGiven conventional yogurt (100 g) which given as snack, twice a day.
Interventions
Eligibility Criteria
You may qualify if:
- BMI \>40kg/m2; perform of other types of bariatric surgery except gastric bypass (i.e. sleeve gastrectomy, adjustable gastric band)
You may not qualify if:
- Administration of antibiotics (other than 1 g ampicillin-sulbactam one hour before surgery), the presence of chronic gastrointestinal, liver or kidney diseases and malignancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 32803709DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
February 14, 2018
First Posted
May 7, 2018
Study Start
April 22, 2013
Primary Completion
December 5, 2014
Study Completion
February 10, 2015
Last Updated
May 7, 2018
Record last verified: 2018-04