Inflammatory Bowel DiseasesNCT04552158
Nutritional Assessment and Impact of the Mediterranean Diet on Patients With Inflammatory Bowel Disease
A study testing Mediterranean diet in people with Inflammatory Bowel Diseases, run by Yasmin Ashraf Mahmoud Osman.
Trial summary
1. Assessment of nutritional status among patients with inflammatory bowel disease using different nutritional assessment tools. 2. Assessment of correlation between nutritional status and disease severity. 3. Assessment of the impact of the Mediterranean diet on the nutritional status of the patients after 3 months. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Mediterranean diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Dec 2022
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with inflammatory bowel disease between 18 to 55 years
Who cannot join
- presence of other diseases that affect the nutritional status of the patients like diabetes mellitus, liver cirrhosis, chronic kidney disease, and malignancy
Trial locations and contacts
No sites are listed yet.
About this study
- Assessment of nutritional status among patients with inflammatory bowel disease using different nutritional assessment tools.
- Assessment of correlation between nutritional status and disease severity.
- Assessment of the impact of the Mediterranean diet on the nutritional status of the patients after 3 months.
Read the detailed description
Inflammatory bowel diseases (IBD) comprise a variety of disorders that result from the continuous activation of the immunoinflammatory cascade, whose etiology has not been defined in some cases. Classical IBD include Crohn's disease (CD), ulcerative colitis (UC), and indeterminate colitis. These diseases are chronic and are characterized by alternating periods of recurrence and remission.
The European Society of Clinical Nutrition and Metabolism (ESPEN) defined malnutrition as a state resulting from lack of uptake or intake of nutrition leading to altered body composition (decreased fat-free mass and body cell mass), resulting in diminished physical and mental function and impaired clinical outcome from disease.
The prevalence of Malnutrition in patients with inflammatory bowel disease (IBD) is very high. it presents in up to 70% of patients with active disease and up to 38% in patients with remission.
Several factors contribute to the malnutrition in IBD including insufficient nutrient intake as a consequence of impaired appetite (anorexia, stomachache), short bowel syndrome, impaired nutrient absorption (diarrhea, villus atrophy, bowel resection, intestinal flora overgrowth), increased nutrient losses (bleeding, fistulae), and food-drug interaction.
Malnutrition in IBD has been associated with several adverse clinical outcomes. IBD patients with nutritional deficiencies may present with higher mortality rate, length of stay in the hospital, infectious rate, and even thromboembolic events than those without nutritional deficiencies. Furthermore, undernutrition in patients with postoperative conditions has been associated with increased complications such as anastomotic leakage and breakdown, infection including sepsis and pneumonia, prolonged hospitalization, and increased mortality.
IBD is clearly associated with intestinal dysbiosis. Changes in the microbiome have a pivotal role in determining the onset of the pathology, when the genetic background of the individual makes him/her predisposed and other concomitant environmental factors intervene. Results of studies aimed at characterizing the microbiota of patients suffering from IBD, even sometimes with checkered results, indicate a generalized decrease in biodiversity, measured by an appropriate parameter-alpha-as well as a reduction in specific taxa including Firmicutes and Bacteroidetes, Lactobacillus and Eubacterium. IBD patients also present a reduction in species producing butyrate, a short chain fatty acid positively modulating intestinal homeostasis and reducing inflammation.
Regarding environmental factors, accumulating data have proven that various nutritional components in diet can play a significant role in the development and clinical course of IBD. Dietary nutrients alter the composition of the gut microbiota and intestinal permeability, influencing the interaction between the host and gut microbiota.
The Mediterranean diet (MedDiet) is a nutritional model inspired by the traditional dietary pattern of some of the countries of the Mediterranean basin. Mediterranean dietary pattern (MDP) gather the following characteristics: abundant consumption of olive oil and high consumption of fruits, vegetables, cereals (preferably as whole grain), legumes, nuts and seeds. The MDP also includes moderate consumption of fish and shellfish, white meat, eggs, and fermented dairy products (cheese and yogurt), as well as relatively small amounts of red meat, processed meats, and foods rich in sugars. Frequent but moderate intake of wine, especially red wine with meals is also recommended.
Results from clinical and translational research on the Mediterranean diet point to its possible meaningful use in managing IBD, and thus additional studies could have the potential to add further insights to the field. Concerning published data, it was observed that 153 Italian healthy subjects were investigated for their dietary habits and their gut microbiota was assessed, and high-level adherence to a Mediterranean diet was found to beneficially impact the gut microbiota and associated metabolome. These studies provided the first concrete evidence for the interconnection between Mediterranean dietary patterns, gut microbiota and microbial metabolites as they observed that the consumption of fruit, vegetables and legumes by subjects with satisfactory adherence to the Mediterranean diet was associated with an increase in fecal SCFA levels, an effect that was likely boosted by bacteria belonging to both the Firmicutes and Bacteroidetes capable of degrading carbohydrates not digestible by the host. When eight adult patients suffering from CD followed the Mediterranean diet for 6 weeks, their transcriptome analysis showed a change in expression of more than 3000 genes; changes in the intestinal microbiota, although not significant, showed a trend towards normalization with an increase in the expression of Bacteroidetes (17.89% to 18.74%), Clostridium cluster IV (19.2% to 21.86%) and Clostridium cluster XIVa (26.78% to 28.79%) and a decrease in the abundance of Proteobacteria (5.93% to 5.48%) and Bacillaceae (4.65% to 4.21%).
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Mediterranean diet
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean dietDietary supplement
The Mediterranean diet (MedDiet) is a nutritional model inspired by the traditional dietary pattern of some of the countries of the Mediterranean basin. Mediterranean dietary pattern (MDP) gather the following characteristics: abundant consumption of olive oil and high consumption of fruits, vegetables, cereals (preferably as whole grain), legumes, nuts and seeds. The MDP also includes moderate consumption of fish and shellfish, white meat, eggs, and fermented dairy products (cheese and yogurt), as well as relatively small amounts of red meat, processed meats, and foods rich in sugars. Frequent but moderate intake of wine, especially red wine with meals is also recommended
| Study group | Role | What they receive |
|---|---|---|
| controlled group | No intervention | patients with IBD who will be assessed for their nutritional status at day 0 and after 3 months of medical management only |
| experimental group | Experimental | patients with IBD who will be assessed for their nutritional status at day 0 and after 3 months of medical management and nutritional management in the form of the Mediterranean diet Receives: Dietary Supplement: Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of nutritional status among patients with inflammatory bowel disease using body weight
current body weight in kilograms will be measured
Measured: Two time points: Change in body weight at patient presentation and after 3 months of medical management only
Assessment of nutritional status among patients with inflammatory bowel disease using body mass index (BMI)
current body weight in kilograms and height in meters will be measured BMI is calculated in kg/m2
Measured: Two time points: Change in BMI at patient presentation and after 3 months of medical management only
Assessment of nutritional status among patients with inflammatory bowel disease using the anthropometric measures
triceps skin fold thickness (TST) in mm, mid arm circumference(MAC) in cm and mid arm muscle circumference in cm (MAMC) MAMC (cm) = MAC(cm) - { 0.314 X TST(mm) }.
Measured: Two time points: Change in the anthropometric parameters at patient presentation and after 3 months of medical management only
Assessment of nutritional status among patients with inflammatory bowel disease using prognostic nutritional index (PNI)
prognostic nutritional index (PNI) which is score derived from total lymphocytic count (TLC)and serum albumin (PNI = albumin g/dl x 10 + TLC/µL x 0.005)
Measured: Two time points: Change in PNI score at patient presentation and after 3 months of medical management only
Assessment of nutritional status among patients with inflammatory bowel disease using controlling nutritional status(CONUT)
controlling nutritional status (CONUT) is also a score derived from total lymphocytic count, serum albumin and blood cholesterol level
Measured: Two time points: Change in CONUT score at patient presentation and after 3 months of medical management only
Secondary outcomes (1)
Assessment of the impact of Mediterranean diet on the nutritional status for patients who received the Mediterranean diet after 3 months
This assessment is based on an individualised scoring system of 7 points for the measured nutritional parameters, in which patients who have > 3 points are considered to have a better outcome.
Measured: after 3 months of medical and Mediterranean diet management
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study startOct 2021 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All Patients will be subjected to assessment of their nutritional status at day 0 and after 3 months of only medical management for the control group and of combined medical and nutritional management using Mediterranean dietary pattern for the experimental group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yasmin Ashraf Mahmoud Osman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasmin Ashraf Mahmoud Osman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552158
- Sponsor's protocol ID
- nutrition and IBD
- Status last verified
- Sep 2020
- First submitted
- 6 Sep 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee D, Albenberg L, Compher C, Baldassano R, Piccoli D, Lewis JD, Wu GD. Diet in the pathogenesis and treatment of inflammatory bowel diseases. Gastroenterology. 2015 May;148(6):1087-106. doi: 10.1053/j.gastro.2015.01.007. Epub 2015 Jan 15.
PubMed 25597840Lane ER, Zisman TL, Suskind DL. The microbiota in inflammatory bowel disease: current and therapeutic insights. J Inflamm Res. 2017 Jun 10;10:63-73. doi: 10.2147/JIR.S116088. eCollection 2017.
PubMed 28652796Weber AT, Shah ND, Sauk J, Limketkai BN. Popular Diet Trends for Inflammatory Bowel Diseases: Claims and Evidence. Curr Treat Options Gastroenterol. 2019 Dec;17(4):564-576. doi: 10.1007/s11938-019-00248-z.
PubMed 31705371
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Assessment and Impact of the Mediterranean Diet on Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04552158
- Acronym / sponsor ID
- nutrition and IBD
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yasmin Ashraf Mahmoud OsmanUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 Sep 2020 (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.
- Assessment of nutritional status among patients with inflammatory bowel disease using different nutritional assessment tools.
- Assessment of correlation between nutritional status and disease severity.
- Assessment of the impact of the Mediterranean diet on the nutritional status of the patients after 3 months.
Detailed description
Inflammatory bowel diseases (IBD) comprise a variety of disorders that result from the continuous activation of the immunoinflammatory cascade, whose etiology has not been defined in some cases. Classical IBD include Crohn's disease (CD), ulcerative colitis (UC), and indeterminate colitis. These diseases are chronic and are characterized by alternating periods of recurrence and remission.
The European Society of Clinical Nutrition and Metabolism (ESPEN) defined malnutrition as a state resulting from lack of uptake or intake of nutrition leading to altered body composition (decreased fat-free mass and body cell mass), resulting in diminished physical and mental function and impaired clinical outcome from disease.
The prevalence of Malnutrition in patients with inflammatory bowel disease (IBD) is very high. it presents in up to 70% of patients with active disease and up to 38% in patients with remission.
Several factors contribute to the malnutrition in IBD including insufficient nutrient intake as a consequence of impaired appetite (anorexia, stomachache), short bowel syndrome, impaired nutrient absorption (diarrhea, villus atrophy, bowel resection, intestinal flora overgrowth), increased nutrient losses (bleeding, fistulae), and food-drug interaction.
Malnutrition in IBD has been associated with several adverse clinical outcomes. IBD patients with nutritional deficiencies may present with higher mortality rate, length of stay in the hospital, infectious rate, and even thromboembolic events than those without nutritional deficiencies. Furthermore, undernutrition in patients with postoperative conditions has been associated with increased complications such as anastomotic leakage and breakdown, infection including sepsis and pneumonia, prolonged hospitalization, and increased mortality.
IBD is clearly associated with intestinal dysbiosis. Changes in the microbiome have a pivotal role in determining the onset of the pathology, when the genetic background of the individual makes him/her predisposed and other concomitant environmental factors intervene. Results of studies aimed at characterizing the microbiota of patients suffering from IBD, even sometimes with checkered results, indicate a generalized decrease in biodiversity, measured by an appropriate parameter-alpha-as well as a reduction in specific taxa including Firmicutes and Bacteroidetes, Lactobacillus and Eubacterium. IBD patients also present a reduction in species producing butyrate, a short chain fatty acid positively modulating intestinal homeostasis and reducing inflammation.
Regarding environmental factors, accumulating data have proven that various nutritional components in diet can play a significant role in the development and clinical course of IBD. Dietary nutrients alter the composition of the gut microbiota and intestinal permeability, influencing the interaction between the host and gut microbiota.
The Mediterranean diet (MedDiet) is a nutritional model inspired by the traditional dietary pattern of some of the countries of the Mediterranean basin. Mediterranean dietary pattern (MDP) gather the following characteristics: abundant consumption of olive oil and high consumption of fruits, vegetables, cereals (preferably as whole grain), legumes, nuts and seeds. The MDP also includes moderate consumption of fish and shellfish, white meat, eggs, and fermented dairy products (cheese and yogurt), as well as relatively small amounts of red meat, processed meats, and foods rich in sugars. Frequent but moderate intake of wine, especially red wine with meals is also recommended.
Results from clinical and translational research on the Mediterranean diet point to its possible meaningful use in managing IBD, and thus additional studies could have the potential to add further insights to the field. Concerning published data, it was observed that 153 Italian healthy subjects were investigated for their dietary habits and their gut microbiota was assessed, and high-level adherence to a Mediterranean diet was found to beneficially impact the gut microbiota and associated metabolome. These studies provided the first concrete evidence for the interconnection between Mediterranean dietary patterns, gut microbiota and microbial metabolites as they observed that the consumption of fruit, vegetables and legumes by subjects with satisfactory adherence to the Mediterranean diet was associated with an increase in fecal SCFA levels, an effect that was likely boosted by bacteria belonging to both the Firmicutes and Bacteroidetes capable of degrading carbohydrates not digestible by the host. When eight adult patients suffering from CD followed the Mediterranean diet for 6 weeks, their transcriptome analysis showed a change in expression of more than 3000 genes; changes in the intestinal microbiota, although not significant, showed a trend towards normalization with an increase in the expression of Bacteroidetes (17.89% to 18.74%), Clostridium cluster IV (19.2% to 21.86%) and Clostridium cluster XIVa (26.78% to 28.79%) and a decrease in the abundance of Proteobacteria (5.93% to 5.48%) and Bacillaceae (4.65% to 4.21%).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All Patients will be subjected to assessment of their nutritional status at day 0 and after 3 months of only medical management for the control group and of combined medical and nutritional management using Mediterranean dietary pattern for the experimental group
| Arm | Type | Receives |
|---|---|---|
| controlled group | No intervention | –patients with IBD who will be assessed for their nutritional status at day 0 and after 3 months of medical management only |
| experimental group | Experimental | Dietary Supplement: Mediterranean dietpatients with IBD who will be assessed for their nutritional status at day 0 and after 3 months of medical management and nutritional management in the form of the Mediterranean diet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with inflammatory bowel disease between 18 to 55 years
Key exclusion criteria (1 listed)
- presence of other diseases that affect the nutritional status of the patients like diabetes mellitus, liver cirrhosis, chronic kidney disease, and malignancy
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 |
|---|---|---|
| Mediterranean dietThe Mediterranean diet (MedDiet) is a nutritional model inspired by the traditional dietary pattern of some of the countries of the Mediterranean basin. Mediterranean dietary pattern (MDP) gather the following characteristics: abundant consumption of olive oil and high consumption of fruits, vegetables, cereals (preferably as whole grain), legumes, nuts and seeds. The MDP also includes moderate consumption of fish and shellfish, white meat, eggs, and fermented dairy products (cheese and yogurt), as well as relatively small amounts of red meat, processed meats, and foods rich in sugars. Frequent but moderate intake of wine, especially red wine with meals is also recommended | Dietary supplement | experimental group |
Primary outcome
Assessment of nutritional status among patients with inflammatory bowel disease using body weight
Time frame: Two time points: Change in body weight at patient presentation and after 3 months of medical management only
current body weight in kilograms will be measured
Assessment of nutritional status among patients with inflammatory bowel disease using body mass index (BMI)
Time frame: Two time points: Change in BMI at patient presentation and after 3 months of medical management only
current body weight in kilograms and height in meters will be measured BMI is calculated in kg/m2
Assessment of nutritional status among patients with inflammatory bowel disease using the anthropometric measures
Time frame: Two time points: Change in the anthropometric parameters at patient presentation and after 3 months of medical management only
triceps skin fold thickness (TST) in mm, mid arm circumference(MAC) in cm and mid arm muscle circumference in cm (MAMC) MAMC (cm) = MAC(cm) - { 0.314 X TST(mm) }.
Assessment of nutritional status among patients with inflammatory bowel disease using prognostic nutritional index (PNI)
Time frame: Two time points: Change in PNI score at patient presentation and after 3 months of medical management only
prognostic nutritional index (PNI) which is score derived from total lymphocytic count (TLC)and serum albumin (PNI = albumin g/dl x 10 + TLC/µL x 0.005)
Assessment of nutritional status among patients with inflammatory bowel disease using controlling nutritional status(CONUT)
Time frame: Two time points: Change in CONUT score at patient presentation and after 3 months of medical management only
controlling nutritional status (CONUT) is also a score derived from total lymphocytic count, serum albumin and blood cholesterol level
1 secondary outcome
Assessment of the impact of Mediterranean diet on the nutritional status for patients who received the Mediterranean diet after 3 months
Time frame: after 3 months of medical and Mediterranean diet management
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Background: PubMed 25597840Lee D, Albenberg L, Compher C, Baldassano R, Piccoli D, Lewis JD, Wu GD. Diet in the pathogenesis and treatment of inflammatory bowel diseases. Gastroenterology. 2015 May;148(6):1087-106. doi: 10.1053/j.gastro.2015.01.007. Epub 2015 Jan 15.
- Background: PubMed 28652796Lane ER, Zisman TL, Suskind DL. The microbiota in inflammatory bowel disease: current and therapeutic insights. J Inflamm Res. 2017 Jun 10;10:63-73. doi: 10.2147/JIR.S116088. eCollection 2017.
- Background: PubMed 31705371Weber AT, Shah ND, Sauk J, Limketkai BN. Popular Diet Trends for Inflammatory Bowel Diseases: Claims and Evidence. Curr Treat Options Gastroenterol. 2019 Dec;17(4):564-576. doi: 10.1007/s11938-019-00248-z.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet in people with Inflammatory Bowel Diseases, run by Yasmin Ashraf Mahmoud Osman.
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 1 inclusion and 1 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 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Yasmin A M Osman, assistant lecturer (01099088852, yasmineashraf.7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of nutritional status among patients with inflammatory bowel disease using body weight (time frame: Two time points: Change in body weight at patient presentation and after 3 months of medical management only). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04552158, which also lists 3 linked publications.
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 21 Jul 2021.