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

Primary Purpose

IBS - Irritable Bowel Syndrome, Functional Gastrointestinal Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Diet without NCS
Diet with NCS
Sponsored by
Hospital General de Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for IBS - Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Nallely Hernandez BuenoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Diet without NCS in irritable bowl syndrome

Diet with NCS in irritable bowl syndrome

Diet without NCS in dyspepsia

Diet with NCS in dyspepsia

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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
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.
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.
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
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
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
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
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
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
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.
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.
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
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

Full Information

First Posted
October 8, 2019
Last Updated
October 14, 2019
Sponsor
Hospital General de Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT04129762
Brief Title
Effect of a Diet Without Non-caloric Sweeteners on Gastrointestinal Symptoms in Patients With IBS and Dyspepsia
Acronym
IBS
Official Title
Effect of a Diet Without Non-caloric Sweeteners on Gastrointestinal Symptoms in Patients With Irritable Bowel Syndrome and Dyspepsia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 17, 2019 (Actual)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General de Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome, Functional Gastrointestinal Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diet without NCS in irritable bowl syndrome
Arm Type
Experimental
Arm Description
Participants with irritable bowl syndrome are assigned to a 5 meals divided diet. In which it does not contain any products with NCS
Arm Title
Diet with NCS in irritable bowl syndrome
Arm Type
Active Comparator
Arm Description
Participants with irritable bowl syndrome are assigned to a 5 meals divided diet. In which it contain any products with NCS
Arm Title
Diet without NCS in dyspepsia
Arm Type
Experimental
Arm Description
Participants with dyspepsia are assigned to a 5 meals divided diet. In which it does not contain any products with NCS
Arm Title
Diet with NCS in dyspepsia
Arm Type
Active Comparator
Arm Description
Participants with dyspepsia are assigned to a 5 meals divided diet. In which it contain any products with NCS
Intervention Type
Other
Intervention Name(s)
Diet without NCS
Other Intervention Name(s)
Diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Diet with NCS
Other Intervention Name(s)
Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
The diet without NCS will change the frequency of gastrointestinal symptoms in patients with IBS.
Description
Using ROME III criteria, the frequency of patients who present with gastrointestinal symptoms is monitored.
Time Frame
12 weeks
Title
The diet without NCS will change the frequency of gastrointestinal symptoms in patients with dyspepsia.
Description
Using ROME III criteria, the frequency of patients who present with gastrointestinal symptoms is monitored.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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
Description
For the evaluation we are going to use weight in kilograms
Time Frame
at the week 1, 6 and 12
Title
The changes in the weight of the patients with dyspepsia, from the beginning of the diet, at 6 weeks and at 12 weeks
Description
For the evaluation we are going to use weight in kilograms
Time Frame
at the week 1, 6 and 12
Title
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
Description
We are going to use RJL system IV for body composition we will report the changes in percentage of water, fat and muscle.
Time Frame
at the week 1, 6 and 12
Title
The changes in the body composition in patients with dyspepsia, from the beginning of the diet, at 6 weeks and at 12 weeks
Description
We are going to use RJL system IV for body composition we will report the changes in percentage of water, fat and muscle.
Time Frame
at the week 1, 6 and 12
Title
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
Description
For the evaluation we are going to use waist circumference in centimeters
Time Frame
at the week 1, 6 and 12
Title
The changes in the waist circumference in patients with dyspepsia, from the beginning of the diet, at 6 weeks and at 12 weeks
Description
For the evaluation we are going to use waist circumference in centimeters
Time Frame
at the week 1, 6 and 12
Title
The changes in glucose in the patients with irritable bowel syndrome, from the beginning and end of the diet
Description
For the changes we are going to use glucose in mg / dl
Time Frame
at the week 1 and 12
Title
The changes in glucose in the patients with dyspepsia, from the beginning and end of the diet
Description
For the changes we are going to use glucose in mg / dl
Time Frame
at the week 1 and 12
Title
The changes insulin in the patients with irritable bowel syndrome, at the beginning and end of the diet
Description
For the serological changes in the insulin we are going to use the measure in IU
Time Frame
at the week 1 and 12
Title
The changes insulin in the patients with dyspepsia, at the beginning and end of the diet
Description
For the serological changes in the insulin we are going to use the measure in IU
Time Frame
at the week 1 and 12
Title
The changes in the lipids profile in the patients with irritable bowel syndrome, at the beginning and end of the diet
Description
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.
Time Frame
at the week 1 and 12
Title
The changes in the lipids profile in the patients with dyspepsia, at the beginning and end of the diet.
Description
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.
Time Frame
at the week 1 and 12
Title
Effect of the diet without NCS in gut microbiota in patients with irritable bowel syndrome at the beginning and end of the diet
Description
Using real-time PCR, the effect of the diet without NCS, on the gut microbiota of patients with irritable bowel syndrome
Time Frame
at the week 1 and 12
Title
Effect of the diet without NCS in gut microbiota in patients with dyspepsia at the beginning and end of the diet
Description
Using real-time PCR, the effect of the diet without NCS, on the gut microbiota of patients with dyspepsia
Time Frame
at the week 1 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nallely Bueno Hernendez, PhD
Phone
27892000
Ext
5654
Email
nallely_bh5@yahoo.com.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Viridiana M Mendoza Martinez, B.S.
Phone
2789200
Ext
5654
Email
dinvestigacionhgm@gmail.com
Facility Information:
Facility Name
Nallely Hernandez Bueno
City
Mexico City
State/Province
Cuauhtemoc
ZIP/Postal Code
06720
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nalllely Bueno Hernandez, PhD
Phone
27892000
Ext
5654
Email
nallely_bh5@yahoo.com.mx
First Name & Middle Initial & Last Name & Degree
Viridiana M Mendoza Martinez, B.S.
Phone
5529370762
Email
dinvestigacionhgm@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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