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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Yasmin A M Osman, assistant lecturer contact

01099088852

yasmineashraf.7@gmail.com

Abeer Sh Abd Elrehim, Assistant professor contact

01027745849

sharafabeer@yahoo.com

About this study

  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 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%).

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 groups in NCT04552158
Study groupRoleWhat they receive
controlled groupNo interventionpatients with IBD who will be assessed for their nutritional status at day 0 and after 3 months of medical management only
experimental groupExperimentalpatients 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)
  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.

  1. First posted17 Sep 2020
  2. Study startOct 2021 (estimated)
  3. Primary completionNov 2021 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

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)
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 25597840
  • Lane 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 28652796
  • Weber 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

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.

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