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

NCT04129762 | Unknown DMC

• 1 other identifier: DI/19/301/03/020
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

IBS - Irritable Bowel Syndrome; Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• 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

  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

  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

  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

  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

  at the week 1, 6 and 12

Study Arms (4)

Diet without NCS in irritable bowl syndrome

EXPERIMENTAL

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

Diet with NCS in irritable bowl syndrome

ACTIVE COMPARATOR

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

Diet without NCS in dyspepsia

EXPERIMENTAL

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

Diet with NCS in dyspepsia

ACTIVE COMPARATOR

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

Other: Diet with NCS

Interventions

Diet without NCS OTHER

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.

Also known as: Diet

Diet without NCS in dyspepsia; Diet without NCS in irritable bowl syndrome

Diet with NCS OTHER

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.

Also known as: Diet

Diet with NCS in dyspepsia; Diet with NCS in irritable bowl syndrome

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital General de Mexico: lead

Study Sites (1)

Nallely Hernandez Bueno

Mexico City, Cuauhtemoc, 06720, Mexico

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome; Gastrointestinal Diseases

Interventions

Diet; Zinostatin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Enediynes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Diynes; Polyynes; Alkynes

Central Study Contacts

Nallely Bueno Hernendez, PhD

CONTACT

27892000; nallely_bh5@yahoo.com.mx

Viridiana M Mendoza Martinez, B.S.

CONTACT

2789200; dinvestigacionhgm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator In Medical Science B

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 17, 2019
• Study Start: July 17, 2019
• Primary Completion: August 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 17, 2019

Record last verified: 2019-10

Locations

ME (1)