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

Hospital General de Mexico

Status: Unknown

Conditions: Functional Gastrointestinal Disorders; IBS - Irritable Bowel Syndrome

Treatments: Other: Diet with NCS; Other: Diet without NCS

Study type: Interventional

Funder types: Other

Identifiers

NCT04129762

DI/19/301/03/020

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 4 patient groups

Diet without NCS in irritable bowl syndrome

Experimental group

Description:

Participants with irritable bowl syndrome are assigned to a 5 meals divided diet. In which it does not contain any products with NCS

Treatment:

Other: Diet without NCS

Diet with NCS in irritable bowl syndrome

Active Comparator group

Description:

Participants with irritable bowl syndrome are assigned to a 5 meals divided diet. In which it contain any products with NCS

Treatment:

Other: Diet with NCS

Diet without NCS in dyspepsia

Experimental group

Description:

Participants with dyspepsia are assigned to a 5 meals divided diet. In which it does not contain any products with NCS

Treatment:

Other: Diet without NCS

Diet with NCS in dyspepsia

Active Comparator group

Description:

Participants with dyspepsia are assigned to a 5 meals divided diet. In which it contain any products with NCS

Treatment:

Other: Diet with NCS