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NCT03573258: FIBAR
Dietary Fibers and Satiety in Bariatric Patients
NA trial testing Fiber or Placebo (depending on the randomization) in Bariatric Surgery Candidate in 8 participants. Completed in 4 May 2021.
4 May 2021
Quick facts
| Lead sponsor | University of Zurich |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 8 |
| Start date | 1 June 2018 |
| Primary completion | 4 May 2021 |
| Estimated completion | 4 May 2021 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- Fiber or Placebo (depending on the randomization)
Conditions studied
- Bariatric Surgery Candidate — all drugs for Bariatric Surgery Candidate →
Sponsor
University of Zurich
Who can join
Adults 18 to 80, any sex, with Bariatric Surgery Candidate. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03573258
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Zurich trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03573258 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Zurich
- Last refreshed: 19 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03573258.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing