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Dietary Fibers and Satiety in Bariatric Patients (FIBAR)

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ClinicalTrials.gov Identifier: NCT03573258
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : July 16, 2018
Sponsor:
Collaborator:
Dr. Robert E. Steinert, PhD
Information provided by (Responsible Party):
Marco Bueter, University of Zurich

Brief Summary:

The primary objective is to evaluate the effect of a viscous and fermentable dietary fibre on ad libitum eating in morbidly obese patients before and 6 month after Roux-en-Y gastric bypass (RYGB) surgery.

The secondary objectives are to study the effect of a viscous and fermentable dietary fibre on perceived appetite, the production of short chain fatty acids (SCFA), breath hydrogen (as a marker of large intestinal fermentation), the secretion of gastrointestinal (GI) satiation hormones and glycaemia in morbidly obese patients before and 6 month after RYGB surgery.

The primary study outcome measure is macronutrient and food intake (grams and kcal eaten) at the ad libitum buffet meal as well as time to complete the meal.

Secondary outcome measures are 1) Appetite ratings (validated visual analogue scales, VAS) including hunger, fullness, thirst, desire to eat, and amount of food desired to eat. 2) Plasma concentrations of SCFA (propionate, acetate, butyrate). 3) Breath hydrogen (as a marker of large intestinal fermentation) 4) Plasma concentrations of gastrointestinal hormones (ghrelin, cholecystokinin (CCK), glucagon-like peptide-1 (GLP-1), peptide YY (PYY) and potentially other, yet to be identified gut hormones). 4) Concentrations of plasma insulin and glucagon and blood glucose.

Randomized, single-blinded cross-over trial in 24 morbidly obese human subjects undergoing RYGB (study A, n=12; study B, n=12). Study B also includes an additional pilot study in 6 morbidly obese patients before and 6 month after RYGB surgery. Thus, the total number of subjects including the pilot study is 30.


Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Dietary Supplement: Fiber or Placebo (depending on the randomization) Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, single-blinded cross-over trial in 24 morbidly obese human subjects undergoing RYGB.
Masking: Single (Participant)
Masking Description: single-blinded
Primary Purpose: Supportive Care
Official Title: Effects of Dietary Fibre on Satiety in Morbidly Obese Patients Before and After Bariatric Surgery - a Single Center, Randomized, Single-blinded, Cross-over Study.
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fiber

300 ml of orange juice plus Intervention

  • 6 g of oat beta glucan = FIBER (study A) or
  • 25 g inulin/FOS = FIBER (study B)
Dietary Supplement: Fiber or Placebo (depending on the randomization)
ingestion of dietary fibers prior to meal intake
Other Name: Placebo

Placebo Comparator: Placebo

300 ml of orange juice plus Placebo:

  • 13.5 g maltodextrin = PLACEBO (study A) or
  • 15.5 g maltodextrin = PLACEBO (study B)
Dietary Supplement: Fiber or Placebo (depending on the randomization)
ingestion of dietary fibers prior to meal intake
Other Name: Placebo




Primary Outcome Measures :
  1. food intake [ Time Frame: 75 (study A) /180 (study B) minutes after Fiber intake ]
    macronutrient and food intake (grams and kcal eaten) at the ad libitum buffet meal

  2. fermentation [ Time Frame: up to 5 hours after fiber intake ]
    breath hydrogen


Secondary Outcome Measures :
  1. Appetite ratings on hunger, fullness and satiety [ Time Frame: up to 5 hours after fiber intake ]
    100 mm visual analogue scales (range 0 to 100, representing the strenght of the feeling)

  2. short chain fatty acid levels [ Time Frame: 150 (study A) / 270 (study B) minutes after Fiber intake ]
    Plasma concentrations of SCFA (propionate, acetate, butyrate)

  3. gut hormones [ Time Frame: 150 (study A) / 270 (study B) minutes after Fiber intake ]
    Plasma concentrations of gastrointestinal hormones (ghrelin, CCK, GLP-1, PYY )

  4. glucose metabolism [ Time Frame: 150 (study A) / 270 (study B) minutes after Fiber intake ]
    Concentrations of plasma insulin and glucagon and blood glucose.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Morbidly obese patients undergoing RYGB surgery
  • Male or female, age 18 or over
  • Sufficient understanding of the German language
  • Understand the procedures and the risks associated with the study
  • Willing to adhere to the protocol and sign the consent form (dietary/physical restrictions are a) no alcohol and no xanthine-containing liquids such as coffee, black or green tea, cola, red bull, chocolate 24 h before the study sessions. b) an identical dinner the evening before the study sessions followed by fasting overnight with no additional food or fluid except water. c) no strenuous exercise for 24 h before each treatment)
  • Independently mobile

Exclusion Criteria:

  • Pregnancy or lactation (as determined by questionnaire and/or pregnancy test)
  • Active and significant psychiatric illness including substance misuse
  • Significant cognitive or communication issues
  • Medications with documented effect on food intake or food preference
  • History of significant food allergy and certain dietary restrictions (e.g. Lactose intolerance)
  • Participation in another clinical trial (currently or within the last 30 days)
  • Smoking
  • Chronic or acute medical condition including clinically relevant abnormality in physical exam or laboratory values
  • Consumption of high fiber diets (e.g. vegans, etc.) or fiber supplements or pre and probiotics
  • Pre-operatively: Factors impairing ability to consume a meal such as significant dysphagia, gastric outlet obstruction, or any other factor that prevents subjects from drinking or eating a meal
  • Post-operatively: Factors impairing the ability to consume meal such as significant and persistent surgical complications, any other factors that prevents subjects from drinking or eating a meal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573258


Contacts
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Contact: Marco Bueter, MD PhD +4144 255 8895 marco.bueter@usz.ch

Locations
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Switzerland
University Hospital Zurich Recruiting
Zürich, Zurich, Switzerland, 8091
Contact: Marco Bueter, MD, PhD    +41 44 255 8895    marco.bueter@usz.ch   
Sponsors and Collaborators
University of Zurich
Dr. Robert E. Steinert, PhD
Investigators
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Principal Investigator: Marco Bueter, MD PhD University Hsopital Zurich, Visceral Surgery

Publications:
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Responsible Party: Marco Bueter, Prof. Dr. med., PhD, University of Zurich
ClinicalTrials.gov Identifier: NCT03573258     History of Changes
Other Study ID Numbers: ID 2017-02287
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Information about study subjects will be kept confidential and managed according to the Cantonal Ethical requirements. Access to any information that could link study data to individual subjects will be strictly limited to research personnel involved in the study and the study monitor. Any data forms that include identifying information will be kept in locked files at the University Hospital Zurich (USZ). Data will be recorded on case report forms. Any reports, scientific papers or presentations will not include any information that could be used to identify individuals.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No