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Dietary Fibers and Satiety in Bariatric Patients

NCT03573258 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-05-19

No results posted yet for this study

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.

Conditions

  • Bariatric Surgery Candidate

Interventions

DIETARY_SUPPLEMENT

Fiber or Placebo (depending on the randomization)

ingestion of dietary fibers prior to meal intake

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Marco Bueter, MD PhD · University Hsopital Zurich, Visceral Surgery

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2021-05-04
Completion
2021-05-04

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03573258 on ClinicalTrials.gov