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

NCT04552158 | Unknown

• 1 other identifier: nutrition and IBD
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Assessment of nutritional status among patients with inflammatory bowel disease using different nutritional assessment tools.
2. 2.Assessment of correlation between nutritional status and disease severity.
3. 3.Assessment of the impact of the Mediterranean diet on the nutritional status of the patients after 3 months.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (5)

• Assessment of nutritional status among patients with inflammatory bowel disease using body weight

  current body weight in kilograms will be 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

  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) }.

  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)

  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

  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

  after 3 months of medical and Mediterranean diet management

Study Arms (2)

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

Dietary Supplement: Mediterranean diet

Interventions

Mediterranean diet DIETARY_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

experimental group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with inflammatory bowel disease between 18 to 55 years

You may not qualify if:

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

Sponsors & Collaborators

• Yasmin Ashraf Mahmoud Osman: lead

Related Publications (3)

• 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.

  PMID: 25597840 BACKGROUND

• 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.

  PMID: 28652796 BACKGROUND

• 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.

  PMID: 31705371 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Yasmin A M Osman, assistant lecturer

CONTACT

01099088852; yasmineashraf.7@gmail.com

Abeer Sh Abd Elrehim, Assistant professor

CONTACT

01027745849; sharafabeer@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant lecturer

Model Details: 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

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: September 17, 2020
• Study Start: October 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2022
• Last Updated: July 21, 2021

Record last verified: 2020-09