Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet without NCS | Other | A standard diet in terms of macronutrients will be calculated.
The menu will not contain products with NCS. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nallely Bueno Hernendez, PhD | Contact | 27892000 | 5654 | nallely_bh5@yahoo.com.mx |
| Viridiana M Mendoza Martinez, B.S. | Contact | 2789200 | 5654 | dinvestigacionhgm@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nallely Hernandez Bueno | Recruiting | Mexico City | Cuauhtemoc | 06720 | Mexico |
Not provided
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004032 | Diet |
| D009353 | Zinostatin |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D053281 | Enediynes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Diet with NCS | Other | A standard diet in terms of macronutrients will be calculated.
The menu will contain products with NCS. |
|
|
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 |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053280 | Diynes |
| D053279 | Polyynes |
| D000480 | Alkynes |