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Trial record 24 of 401 for:    PYY

The Metabolic Effects of Prebiotic Supplementation After Roux-en-Y Gastric Bypass Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03517345
Recruitment Status : Completed
First Posted : May 7, 2018
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Fulya Turker, Istanbul University

Tracking Information
First Submitted Date  ICMJE February 14, 2018
First Posted Date  ICMJE May 7, 2018
Last Update Posted Date May 7, 2018
Actual Study Start Date  ICMJE April 22, 2013
Actual Primary Completion Date December 5, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
Appetite regulation [ Time Frame: 6 months ]
Change in baseline appetite at 6th month. Subjective appetite assessed with visual analog scales
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 24, 2018)
  • weight changes [ Time Frame: 6 months ]
    Change in baseline weight (kg) measurements at 6th month.
  • fat mass changes [ Time Frame: 6 months ]
    Change in baseline fat mass (kg) measurements at 6th month.
  • fat free mass changes [ Time Frame: 6 months ]
    Change in baseline fat free mass (kg) measurements at 6th month.
  • excess weight loss changes [ Time Frame: 6 months ]
    Change in excess weight loss (%) throughout 6months.
  • serum glucose changes [ Time Frame: 6 months ]
    Change in serum glucose levels (mg/dl) throughout 6months.
  • serum insulin changes [ Time Frame: 6 months ]
    Change in serum insulin levels (µU/mL) throughout 6months.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Metabolic Effects of Prebiotic Supplementation After Roux-en-Y Gastric Bypass Surgery
Official Title  ICMJE Investigating the Effects of Prebiotic Supplementation on Metabolic Effects of Roux-en-Y Gastric Bypass Surgery: A Prospective Randomized Trial
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Bariatric Surgery
Intervention  ICMJE
  • Dietary Supplement: Prebiotic
    Prebiotic (Inulin+Oligofructose) consumed as 10 g/d in yogurt (200 g/d)
  • Dietary Supplement: Control
    The only yogurt consumed as 200 g/d without prebiotic.
Study Arms  ICMJE
  • Experimental: Prebiotic group
    Given a prebiotic product (inulin + oligofructose; 5 g) mixed with conventional yogurt (100 g) which given as snack, twice a day.
    Intervention: Dietary Supplement: Prebiotic
  • Experimental: Control group
    Given conventional yogurt (100 g) which given as snack, twice a day.
    Intervention: Dietary Supplement: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2018)
32
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 10, 2015
Actual Primary Completion Date December 5, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI >40kg/m2; perform of other types of bariatric surgery except gastric bypass (i.e. sleeve gastrectomy, adjustable gastric band)

Exclusion Criteria: I

  • Administration of antibiotics (other than 1 g ampicillin-sulbactam one hour before surgery), the presence of chronic gastrointestinal, liver or kidney diseases and malignancy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03517345
Other Study ID Numbers  ICMJE 31806
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fulya Turker, Istanbul University
Study Sponsor  ICMJE Istanbul University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Istanbul University
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP