Effect of a Diet Without Non-caloric Sweeteners on Gastrointestinal Symptoms in Patients With IBS and Dyspepsia
NCT ID: NCT04129762
Last Updated: 2019-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2019-07-17
2020-12-31
Brief Summary
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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
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Diet without NCS in irritable bowl syndrome
Participants with irritable bowl syndrome are assigned to a 5 meals divided diet. In which it does not contain any products with NCS
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.
Diet with NCS in irritable bowl syndrome
Participants with irritable bowl syndrome are assigned to a 5 meals divided diet. In which it contain any products with NCS
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.
Diet without NCS in dyspepsia
Participants with dyspepsia are assigned to a 5 meals divided diet. In which it does not contain any products with NCS
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.
Diet with NCS in dyspepsia
Participants with dyspepsia are assigned to a 5 meals divided diet. In which it contain any products with NCS
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Hospital General de Mexico
OTHER_GOV
Responsible Party
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Nallely Bueno Hernández
Investigator In Medical Science B
Locations
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Nallely Hernandez Bueno
Mexico City, Cuauhtemoc, Mexico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DI/19/301/03/020
Identifier Type: -
Identifier Source: org_study_id
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