IBS - Irritable Bowel SyndromeIBSNCT04129762
Effect of a Diet Without Non-caloric Sweeteners on Gastrointestinal Symptoms in Patients With IBS and Dyspepsia
A study testing Diet without NCS and Diet with NCS in people with IBS - Irritable Bowel Syndrome and Functional Gastrointestinal Disorders, run by Hospital General de Mexico at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome, Functional Gastrointestinal Disorders
- What is being tested?
- Diet without NCS and Diet with NCS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteMexico
- Study dates
- 17 Jul 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- Do not consume alcoholic beverages
- No Smoking
- Signing of the informed consent letter expressing your desire to participate as volunteers in the study
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Nallely Hernandez Bueno
Mexico City, Cuauhtemoc, 06720
Nalllely Bueno Hernandez, PhD, 27892000 ext. 5654, nallely_bh5@yahoo.com.mx
Viridiana M Mendoza Martinez, B.S., 5529370762, dinvestigacionhgm@gmail.com
About this study
Official title: Effect of a Diet Without Non-caloric Sweeteners on Gastrointestinal Symptoms in Patients With Irritable Bowel Syndrome and Dyspepsia
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.
Read more
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
Read the 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.
- Being tested
- Diet without NCS, Diet with NCS
- Medical subject headings
- Irritable Bowel Syndrome, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet without NCSOther
Also called Diet
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 NCSOther
Also called Diet
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Diet with NCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
For the evaluation we are going to use weight in kilograms
Measured: 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
For the evaluation we are going to use weight in kilograms
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: at the week 1 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start17 Jul 2019
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nallely Bueno Hernández, Hospital General de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129762
- Sponsor's protocol ID
- DI/19/301/03/020
- Acronym
- IBS
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Diet Without Non-caloric Sweeteners on Gastrointestinal Symptoms in Patients With Irritable Bowel Syndrome and Dyspepsia
- ClinicalTrials.gov ID
- NCT04129762
- Acronym / sponsor ID
- IBS / DI/19/301/03/020
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hospital General de MexicoOther government
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diet without NCS in irritable bowl syndrome | Experimental | Other: Diet without NCSParticipants 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 | Other: Diet with NCSParticipants 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 | Other: Diet without NCSParticipants 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 | Other: Diet with NCSParticipants with dyspepsia are assigned to a 5 meals divided diet. In which it contain any products with NCS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet without NCSAlso: DietA 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. | Other | Diet without NCS in dyspepsia, Diet without NCS in irritable bowl syndrome |
| Diet with NCSAlso: DietA 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 | Diet with NCS in dyspepsia, Diet with NCS in irritable bowl syndrome |
Primary outcome
The diet without NCS will change the frequency of gastrointestinal symptoms in patients with IBS.
Time frame: 12 weeks
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.
Time frame: 12 weeks
Using ROME III criteria, the frequency of patients who present with gastrointestinal symptoms is monitored.
14 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at the week 1 and 12
The changes in glucose in the patients with dyspepsia, from the beginning and end of the diet
Time frame: at the week 1 and 12
The changes insulin in the patients with irritable bowel syndrome, at the beginning and end of the diet
Time frame: at the week 1 and 12
The changes insulin in the patients with dyspepsia, at the beginning and end of the diet
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: at the week 1 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet without NCS and Diet with NCS in people with IBS - Irritable Bowel Syndrome and Functional Gastrointestinal Disorders, run by Hospital General de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nallely Bueno Hernendez, PhD (27892000 ext. 5654, nallely_bh5@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diet without NCS will change the frequency of gastrointestinal symptoms in patients with IBS. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019.