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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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IBS - Irritable Bowel Syndrome, Functional Gastrointestinal Disorders

Intervention / Treatment
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* Other: Diet without NCS
* Other: Diet with NCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both sexes from 18 to 65 years old Diagnosis of IBS or Dyspepsia Patients with dyspepsia must have endoscopy Normal or overweight BMI (18.5 - 29.9 kg / m2) Not suffering from chronic non-communicable or infectious diseases Follow the meal plan that is being given. Do not consume alcoholic beverages No Smoking Signing of the informed consent letter expressing your desire to participate as volunteers in the study Exclusion Criteria: People who at the time of their selection are studying with acute illness of any kind Type 1 or 2 diabetes. Diagnosis of malabsorption syndrome Neoplasia Inflammatory bowel disease Medicine that affects the gastrointestinal tract Women who at the time of their selection are pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet without NCS in irritable bowl syndrome<br>Participants with irritable bowl syndrome are assigned to a 5 meals divided diet. In which it does not contain any products with NCS | Other: Diet without NCS<br>* 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.<br>* Other names: Diet;|
| Active Comparator: Diet with NCS in irritable bowl syndrome<br>Participants with irritable bowl syndrome are assigned to a 5 meals divided diet. In which it contain any products with NCS | Other: Diet with NCS<br>* 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.<br>* Other names: Diet;|
| Experimental: Diet without NCS in dyspepsia<br>Participants with dyspepsia are assigned to a 5 meals divided diet. In which it does not contain any products with NCS | Other: Diet without NCS<br>* 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.<br>* Other names: Diet;|
| Active Comparator: Diet with NCS in dyspepsia<br>Participants with dyspepsia are assigned to a 5 meals divided diet. In which it contain any products with NCS | Other: Diet with NCS<br>* 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.<br>* Other names: Diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diet without NCS will change the frequency of gastrointestinal symptoms in patients with IBS. | Using ROME III criteria, the frequency of patients who present with gastrointestinal symptoms is monitored. | 12 weeks | 
| The diet without NCS will change the frequency of gastrointestinal symptoms in patients with dyspepsia. | Using ROME III criteria, the frequency of patients who present with gastrointestinal symptoms is monitored. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in the weight of the patients with irritable bowel syndrome, from the beginning of the diet, at 6 weeks and at 12 weeks | For the evaluation we are going to use weight in kilograms | at the week 1, 6 and 12 | 
| The changes in the weight of the patients with dyspepsia, from the beginning of the diet, at 6 weeks and at 12 weeks | For the evaluation we are going to use weight in kilograms | at the week 1, 6 and 12 | 
| The changes in the body composition in patients with irritable bowel syndrome, from the beginning of the diet, at 6 weeks and at 12 weeks | We are going to use RJL system IV for body composition we will report the changes in percentage of water, fat and muscle. | at the week 1, 6 and 12 | 
| The changes in the body composition in patients with dyspepsia, from the beginning of the diet, at 6 weeks and at 12 weeks | We are going to use RJL system IV for body composition we will report the changes in percentage of water, fat and muscle. | at the week 1, 6 and 12 | 
| The changes in the waist circumference in patients with irritable bowel syndrome, from the beginning of the diet, at 6 weeks and at 12 weeks | For the evaluation we are going to use waist circumference in centimeters | at the week 1, 6 and 12 | 
| The changes in the waist circumference in patients with dyspepsia, from the beginning of the diet, at 6 weeks and at 12 weeks | For the evaluation we are going to use waist circumference in centimeters | at the week 1, 6 and 12 | 
| The changes in glucose in the patients with irritable bowel syndrome, from the beginning and end of the diet | For the changes we are going to use glucose in mg / dl | at the week 1 and 12 | 
| The changes in glucose in the patients with dyspepsia, from the beginning and end of the diet | For the changes we are going to use glucose in mg / dl | at the week 1 and 12 | 
| The changes insulin in the patients with irritable bowel syndrome, at the beginning and end of the diet | For the serological changes in the insulin we are going to use the measure in IU | at the week 1 and 12 | 
| The changes insulin in the patients with dyspepsia, at the beginning and end of the diet | For the serological changes in the insulin we are going to use the measure in IU | at the week 1 and 12 | 
| The changes in the lipids profile in the patients with irritable bowel syndrome, at the beginning and end of the diet | For the serological changes in the lipid profile we are going to use triglycerides in mg/dl, total cholesterol in mg/dl, HDL in mg/dl, cholesterol, LDL in mg / dl. | at the week 1 and 12 | 
| The changes in the lipids profile in the patients with dyspepsia, at the beginning and end of the diet. | For the serological changes in the lipid profile we are going to use triglycerides in mg/dl, total cholesterol in mg/dl, HDL in mg/dl, cholesterol, LDL in mg / dl. | at the week 1 and 12 | 
| Effect of the diet without NCS in gut microbiota in patients with irritable bowel syndrome at the beginning and end of the diet | Using real-time PCR, the effect of the diet without NCS, on the gut microbiota of patients with irritable bowel syndrome | at the week 1 and 12 | 
| Effect of the diet without NCS in gut microbiota in patients with dyspepsia at the beginning and end of the diet | Using real-time PCR, the effect of the diet without NCS, on the gut microbiota of patients with dyspepsia | at the week 1 and 12 |