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Nutritional Assessment and Impact of the Mediterranean Diet on Patients With Inflammatory Bowel Disease

Primary Purpose

Inflammatory Bowel Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mediterranean diet
Sponsored by
Yasmin Ashraf Mahmoud Osman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with inflammatory bowel disease between 18 to 55 years

Exclusion Criteria:

  • presence of other diseases that affect the nutritional status of the patients like diabetes mellitus, liver cirrhosis, chronic kidney disease, and malignancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    controlled group

    experimental group

    Arm Description

    patients with IBD who will be assessed for their nutritional status at day 0 and after 3 months of medical management only

    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

    Outcomes

    Primary Outcome Measures

    Assessment of nutritional status among patients with inflammatory bowel disease using body weight
    current body weight in kilograms will be measured
    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
    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) }.
    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)
    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

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    September 6, 2020
    Last Updated
    July 19, 2021
    Sponsor
    Yasmin Ashraf Mahmoud Osman
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04552158
    Brief Title
    Nutritional Assessment and Impact of the Mediterranean Diet on Patients With Inflammatory Bowel Disease
    Official Title
    Nutritional Assessment and Impact of the Mediterranean Diet on Patients With Inflammatory Bowel Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2021 (Anticipated)
    Primary Completion Date
    November 2021 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Yasmin Ashraf Mahmoud Osman

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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%).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammatory Bowel Diseases

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    controlled group
    Arm Type
    No Intervention
    Arm Description
    patients with IBD who will be assessed for their nutritional status at day 0 and after 3 months of medical management only
    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Mediterranean diet
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Assessment of nutritional status among patients with inflammatory bowel disease using body weight
    Description
    current body weight in kilograms will be measured
    Time Frame
    Two time points: Change in body weight at patient presentation and after 3 months of medical management only
    Title
    Assessment of nutritional status among patients with inflammatory bowel disease using body mass index (BMI)
    Description
    current body weight in kilograms and height in meters will be measured BMI is calculated in kg/m2
    Time Frame
    Two time points: Change in BMI at patient presentation and after 3 months of medical management only
    Title
    Assessment of nutritional status among patients with inflammatory bowel disease using the anthropometric measures
    Description
    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) }.
    Time Frame
    Two time points: Change in the anthropometric parameters at patient presentation and after 3 months of medical management only
    Title
    Assessment of nutritional status among patients with inflammatory bowel disease using prognostic nutritional index (PNI)
    Description
    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)
    Time Frame
    Two time points: Change in PNI score at patient presentation and after 3 months of medical management only
    Title
    Assessment of nutritional status among patients with inflammatory bowel disease using controlling nutritional status(CONUT)
    Description
    controlling nutritional status (CONUT) is also a score derived from total lymphocytic count, serum albumin and blood cholesterol level
    Time Frame
    Two time points: Change in CONUT score at patient presentation and after 3 months of medical management only
    Secondary Outcome Measure Information:
    Title
    Assessment of the impact of Mediterranean diet on the nutritional status for patients who received the Mediterranean diet after 3 months
    Description
    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.
    Time Frame
    after 3 months of medical and Mediterranean diet management

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with inflammatory bowel disease between 18 to 55 years Exclusion Criteria: presence of other diseases that affect the nutritional status of the patients like diabetes mellitus, liver cirrhosis, chronic kidney disease, and malignancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yasmin A M Osman, assistant lecturer
    Phone
    01099088852
    Email
    yasmineashraf.7@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abeer Sh Abd Elrehim, Assistant professor
    Phone
    01027745849
    Email
    sharafabeer@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25597840
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28652796
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    31705371
    Citation
    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.
    Results Reference
    background

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    Nutritional Assessment and Impact of the Mediterranean Diet on Patients With Inflammatory Bowel Disease

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