ProteIn Nutrition in Crohn's Disease

NCT05572008 | Unknown

• 1 other identifier: 297431
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Muscles are essential for good quality of life. The investigators have shown that when children with Crohn's disease eat protein, only very little of it enters the muscles, leading to poor muscle growth and fatigue. The investigators want to find the reasons for this. The investigators will recruit 20 Crohn's disease patients and a matched group of healthy kids. The investigators will measure:

• Daily food intake and muscle strength.
• Protein absorption by giving our participants a milk protein test drink and take regular blood samples after.
• Muscle mass with MRI. This study will help understand how protein is handled in these patients.

Conditions

Crohn Disease

Keywords

Crohn's Disease (CD); Muscle Protein Synthesis; Muscle Protein Breakdown; Magnetic Resonance Imaging (MRI); Amino Acids (AAs); Essential Amino Acid (EAA)

Outcome Measures

Primary Outcomes (1)

• Assess protein intake

  Detailed 3-days protein intake via Intake24 online questionnaire

  15 minutes/ history diary intake

Secondary Outcomes (9)

• Assess calories, carbohydrate, fat and micronutrient intake

  15 minutes/ history diary intake

• Assess eating behaviour

  10 minutes

• Assess eating behaviour

  10 minutes

• Post-prandial protein digestibility

  360 minutes

• Assess body composition

  30 minutes

Study Arms (2)

paediatric Crohn's disease

EXPERIMENTAL

CD young population (ages 12-17 years) - N=20

Behavioral: Protein nutrition in paediatric Crohn's disease

Healthy volunteers

ACTIVE COMPARATOR

Age-, BMI- and gender-matched healthy volunteers (HV) - N=20

Behavioral: Protein nutrition in paediatric Crohn's disease

Interventions

Protein nutrition in paediatric Crohn's disease BEHAVIORAL

All participants (N = 40) will undergo the same study procedures: Eating behaviour questionnaire(s) completion Duration: 5 minutes Frequency 2 Dietary intake data via online computerised recall Duration: 60 minutes Frequency: 3 Collection of blood sample via venepuncture Duration: 15 minutes Frequency 1 Strength Tests Duration: 30 minutes Frequency: 1 Half the participants (N = 20) will return for two more visits and will undergo the following procedures: MRI Scan Duration: 30 minutes Frequency: 1 Consumption of intrinsically labelled protein Duration: 15 minutes Frequency: 1 Insertion of cannulae into hand Duration: 15 minutes Frequency: 1 Collection of blood sample via cannulae (for protein digestion and inflammatory markers and study endpoints outlined below) Duration: 1 minute Frequency: 17

Healthy volunteers; paediatric Crohn's disease

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 12-17 years
• BMI \<30 kg/m2 (all)
• \*\*Documented diagnosis of CD previously confirmed by endoscopy and histology at least 6 months prior to enrolment (CD group only)
• \*\*Stable CD defined as no change in medication in the last 3 months (including corticosteroids) and no CD-related surgical intervention in the last 6 months (CD group only)
• Able to participate fully in all aspects of the clinical trial (all)
• Written informed consent obtained and documented (all) \*\*n/a to HV's

You may not qualify if:

• A current diagnosis of UC, indeterminate colitis or microscopic colitis
• A diagnosis of short-bowel syndrome
• Serious underlying disease other than \*\*CD that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study
• Contraindications for MRI scanning e.g. pacemaker
• Dairy intolerance/milk protein allergy
• Non-English speakers \*\*n/a to HV's

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

David Greenfield Human Physiology Unit, B Floor, Medical school, Queens Medical centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

RECRUITING

Related Publications (19)

• Schneider SM, Al-Jaouni R, Filippi J, Wiroth JB, Zeanandin G, Arab K, Hebuterne X. Sarcopenia is prevalent in patients with Crohn's disease in clinical remission. Inflamm Bowel Dis. 2008 Nov;14(11):1562-8. doi: 10.1002/ibd.20504.

  PMID: 18478564 BACKGROUND

• van Langenberg DR, Della Gatta P, Hill B, Zacharewicz E, Gibson PR, Russell AP. Delving into disability in Crohn's disease: dysregulation of molecular pathways may explain skeletal muscle loss in Crohn's disease. J Crohns Colitis. 2014 Jul;8(7):626-34. doi: 10.1016/j.crohns.2013.11.024. Epub 2013 Dec 13.

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• Gassull MA, Cabre E. Nutrition in inflammatory bowel disease. Curr Opin Clin Nutr Metab Care. 2001 Nov;4(6):561-9. doi: 10.1097/00075197-200111000-00018.

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• Davies A, Nixon A, Muhammed R, Tsintzas K, Kirkham S, Stephens FB, Moran GW. Reduced skeletal muscle protein balance in paediatric Crohn's disease. Clin Nutr. 2020 Apr;39(4):1250-1257. doi: 10.1016/j.clnu.2019.05.017. Epub 2019 May 25.

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• Moughan PJ, Wolfe RR. Determination of Dietary Amino Acid Digestibility in Humans. J Nutr. 2019 Dec 1;149(12):2101-2109. doi: 10.1093/jn/nxz211.

  PMID: 31529051 BACKGROUND

• Koopman R, Walrand S, Beelen M, Gijsen AP, Kies AK, Boirie Y, Saris WH, van Loon LJ. Dietary protein digestion and absorption rates and the subsequent postprandial muscle protein synthetic response do not differ between young and elderly men. J Nutr. 2009 Sep;139(9):1707-13. doi: 10.3945/jn.109.109173. Epub 2009 Jul 22.

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MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Gordon Moran, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Kostas Tsintzas, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bayan Aljilani, MSc

CONTACT

07866010685; mzxba1@exmail.nottingham.ac.uk

Gordon Moran, PhD

CONTACT

0115 9249924; mszgwm@exmail.nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: October 7, 2022
• Study Start: July 20, 2022
• Primary Completion: December 28, 2022
• Study Completion: May 25, 2023
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 7 years

Locations

GB (1)