NCT04129762

Effect of a Diet Without Non-caloric Sweeteners on Gastrointestinal Symptoms in Patients With IBS and Dyspepsia

Effect of a Diet Without Non-caloric Sweeteners on Gastrointestinal Symptoms in Patients With Irritable Bowel Syndrome and Dyspepsia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Hospital General de Mexico · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Digestive Functional Disorders (DFD), represent 50% of medical check ups, the symptoms interfere with patients quality of life and generate high health costs. On the other hand, with the worldwide overweight and obesity increase,causing an over production of low-calorie products, which increase the non-caloric sweeteners (NCS) consumption. Hypothesis: A diet without NCS will reduce gastrointestinal symptoms in volunteers with dyspepsia and IBS. Objective: To asses the effect of a diet without NCS, on the gastrointestinal symptoms in patients with dyspepsia and IBS. Secondary Objectives: To compare the effect of a diet without NCS against a diet with NCS on anthropometry, changes in body composition, biochemical parameters, glucose and insulin. To asses the change in the gut microbiota using real-time PCR (polymerase chain reaction) Methodology: it will be an experimental, open, parallel, controlled study lasting 12 weeks, patients with dyspepsia or IBS will be randomized assigned to a diet with or without NCS. Laboratory studies, dietary and symptoms questionnaires, anthropometry measurements and faecal sample will be carried out. Analysis Results: A double data capture will be carried out to minimize errors, for the statistical analysis of using the Statistical Package for the Social Sciences (SPSS) version 25, descriptive statistics will be used to report the baseline data of the volunteers. Using means and standard deviation, the variables of gastrointestinal symptoms will be used a chi-square test and a p \<0.05 will be considered significant. Different analyzes will be done to evaluate volunteers with IBS and those with dyspepsia. For the intestinal microbiota analysis, a comparison will be made between the percentages of Firmicutes, Bacteroidetes and Actinobacteria of sample 1 and 2 and a chi-square test will be performed considering a p \<0.05 significant

Detailed description

Recruitment will be carried out in the gastroenterology service, where patients will have their diagnosis of IBS or dyspepsia, participants are invited to participate in the study to subsequently sign the informed consent. Once signed the patient is scheduled for blood studies, their nutritional evaluation will be carried out and their menu will be delivered. Patients will be followed for 12 weeks to re-conduct their nutritional evaluation and laboratory studies.

Conditions

• IBS - Irritable Bowel Syndrome
• Functional Gastrointestinal Disorders

Interventions

Type	Name	Description
OTHER	Diet without NCS	A standard diet in terms of macronutrients will be calculated. * 55% Carbohydrates * 20% protein * 25% Lipids The energy calculation will be done with the Harris Benedict formula and a diet with equivalents will be made and then a menu distributed in 5 meals, lasting 7 days. The menu will not contain products with NCS.
OTHER	Diet with NCS	A standard diet in terms of macronutrients will be calculated. * 55% Carbohydrates * 20% protein * 25% Lipids The energy calculation will be done with the Harris Benedict formula and a diet with equivalents will be made and then a menu distributed in 5 meals, lasting 7 days. The menu will contain products with NCS.

Timeline

• Start date: 2019-07-17
• Primary completion: 2020-08-31
• Completion: 2020-12-31
• First posted: 2019-10-17
• Last updated: 2019-10-17

Locations

1 site across 1 country: Mexico