ProteIn Nutrition in Crohn's Disease (PINC)

October 6, 2022 updated by: University of Nottingham

Investigating Protein Nutrition in Paediatric Crohn's Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Muscle mass is maintained through the daily balance of muscle protein synthesis (MPS) and muscle protein breakdown (MPB), with the essential amino acid (EAA) components of a meal and muscle contraction being the primary stimulators of MPS. Adult patients with active CD ingest considerably less daily protein intake than age- BMI- matched healthy controls [CD, 70.3 g ± 6.1; HV, 92.6 g ± 7.8, p = 0.03]. Similar observations may be true for children with inactive CD where protein intake is lower with 79 ± 5g/day reported in CD and 90 ± 10g/day reported in HV. In male paediatric patients with long term CD, muscle metabolism is perturbed by a negative branched chain amino acid balance in the forearm. CD may have a significant effect on protein digestion and absorption, blunting the MPS response to feeding, leading to a chronic muscle mass reduction that may persist even when in remission.

The essential amino acid (EAA) components of a protein-meal are crucial for the stimulation of muscle protein synthesis (MPS) and we have shown of all the EAA, leucine plays a key role in driving MPS. Low serum levels EAA/leucine have been reported in adult CD but their role in the aetiology of sarcopenia in paediatric CD is unknown. Further, how CD affects the protein digestion/absorption and how this contributes to low EAA/leucine remains unclear. Recent advances in stable isotope tracer techniques now enable a more accurate determination of protein digestibility. By following the appearance of intrinsically labelled AAs into the blood upon digestion of the intrinsically labelled protein, alongside the appearance of label-free AAs, protein digestibility can be accurately determined.

Main aims: To accurately measure protein intake and fasting plasma EAA and non-EAA in paediatric CD. The investigators will use an intrinsically labelled protein milk to investigate protein digestion and absorption and link these findings to whole body muscle mass as measured through MRI.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Recruiting
        • David Greenfield Human Physiology Unit, B Floor, Medical school, Queens Medical centre
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 12-17 years
  2. BMI <30 kg/m2 (all)
  3. **Documented diagnosis of CD previously confirmed by endoscopy and histology at least 6 months prior to enrolment (CD group only)
  4. **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)
  5. Able to participate fully in all aspects of the clinical trial (all)
  6. Written informed consent obtained and documented (all) **n/a to HV's

Exclusion Criteria:

  1. A current diagnosis of UC, indeterminate colitis or microscopic colitis
  2. A diagnosis of short-bowel syndrome
  3. 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
  4. Contraindications for MRI scanning e.g. pacemaker
  5. Dairy intolerance/milk protein allergy
  6. Non-English speakers **n/a to HV's

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: paediatric Crohn's disease
CD young population (ages 12-17 years) - N=20
Behavioral: Protein nutrition in paediatric Crohn's disease

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
Active Comparator: Healthy volunteers
Age-, BMI- and gender-matched healthy volunteers (HV) - N=20
Behavioral: Protein nutrition in paediatric Crohn's disease

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess protein intake
Time Frame: 15 minutes/ history diary intake
Detailed 3-days protein intake via Intake24 online questionnaire
15 minutes/ history diary intake

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess calories, carbohydrate, fat and micronutrient intake
Time Frame: 15 minutes/ history diary intake
Detailed 3-day calorie, carbohydrate, fat and micronutrient intake via Intake24 online questionnaire
15 minutes/ history diary intake
Assess eating behaviour
Time Frame: 10 minutes
Child Eating Behaviour, (CEBQ) questionnaire
10 minutes
Assess eating behaviour
Time Frame: 10 minutes
Child Tree-Factor Eating Questionnaire (CTFEQr17) questionnaire
10 minutes
Post-prandial protein digestibility
Time Frame: 360 minutes
Postprandial plasma AA appearance/digestibility via collection of blood sample
360 minutes
Assess body composition
Time Frame: 30 minutes
Whole-body muscle mass using 3T
30 minutes
Assess body composition
Time Frame: Assess body composition
Whole-body muscle mass using 3T
Assess body composition
Measure serum inflammatory cytokines
Time Frame: 15 minutes
Serum key cytokines and hormones: IL-1, IL-6, IL-10, IL-15, TNF, GH, IGF-1, testosterone
15 minutes
Quantify muscle strength
Time Frame: 30 minutes
Muscle strength will be assessed via maximal forearm contractions using a handgrip dynamometer
30 minutes
Assess body composition
Time Frame: 30 minutes
Intra-myocellular and extra-myocellular lipid content using 3T
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Investigators

  • Principal Investigator: Gordon Moran, PhD, University of Nottingham
  • Principal Investigator: Kostas Tsintzas, PhD, University of Nottingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2022

Primary Completion (Anticipated)

December 28, 2022

Study Completion (Anticipated)

May 25, 2023

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 297431

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The samples provided by my child and the information gathered about my child can be stored by the University of Nottingham at the Research Tissue Bank (DI William Dunn-Licence Number 12265), for possible use in future studies

IPD Sharing Time Frame

7 years

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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