Dietary Fibers and Satiety in Bariatric Patients

NCT03573258 | Completed DMC

• 1 other identifier: ID 2017-02287
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (2)

• food intake

  macronutrient and food intake (grams and kcal eaten) at the ad libitum buffet meal

  75 (study A) /180 (study B) minutes after Fiber intake

• fermentation

  breath hydrogen

  up to 5 hours after fiber intake

Secondary Outcomes (4)

• Appetite ratings on hunger, fullness and satiety

  up to 5 hours after fiber intake

• short chain fatty acid levels

  150 (study A) / 270 (study B) minutes after Fiber intake

• gut hormones

  150 (study A) / 270 (study B) minutes after Fiber intake

• glucose metabolism

  150 (study A) / 270 (study B) minutes after Fiber intake

Study Arms (2)

Fiber

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

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)

Interventions

Fiber or Placebo (depending on the randomization) DIETARY_SUPPLEMENT

ingestion of dietary fibers prior to meal intake

Also known as: Placebo

Fiber; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (2)

• Slavin J. Fiber and prebiotics: mechanisms and health benefits. Nutrients. 2013 Apr 22;5(4):1417-35. doi: 10.3390/nu5041417.

  PMID: 23609775 BACKGROUND

• Clark MJ, Slavin JL. The effect of fiber on satiety and food intake: a systematic review. J Am Coll Nutr. 2013;32(3):200-11. doi: 10.1080/07315724.2013.791194.

  PMID: 23885994 BACKGROUND

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Marco Bueter, MD PhD

  University Hsopital Zurich, Visceral Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med., PhD

Model Details: Randomized, single-blinded cross-over trial in 24 morbidly obese human subjects undergoing RYGB.

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: June 29, 2018
• Study Start: June 1, 2018
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)