Crohn DiseasePINCNCT05572008
ProteIn Nutrition in Crohn's Disease
A study testing Protein nutrition in paediatric Crohn's disease in people with Crohn Disease, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Protein nutrition in paediatric Crohn's disease
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jul 2022to 25 May 2023
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
David Greenfield Human Physiology Unit, B Floor, Medical school, Queens Medical centre
Nottingham, Nottinghamshire, NG7 2UH
Aline Nixon, 115 8230 127 ext. 30196, Aline.nixon@nottingham.ac.uk
Sara Brown, 115 8230 127 ext. 30434, sara.brown@nottingham.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Crohn Disease
- Being tested
- Protein nutrition in paediatric Crohn's disease
- Keywords
- Crohn's Disease (CD), Muscle Protein Synthesis, Muscle Protein Breakdown, Magnetic Resonance Imaging (MRI), Amino Acids (AAs), Essential Amino Acid (EAA)
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein nutrition in paediatric Crohn's diseaseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| paediatric Crohn's disease | Experimental | CD young population (ages 12-17 years) - N=20 Receives: Behavioral: Protein nutrition in paediatric Crohn's disease |
| Healthy volunteers | Active comparator | Age-, BMI- and gender-matched healthy volunteers (HV) - N=20 Receives: Behavioral: Protein nutrition in paediatric Crohn's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess protein intake
Detailed 3-days protein intake via Intake24 online questionnaire
Measured: 15 minutes/ history diary intake
Secondary outcomes (9)
Assess calories, carbohydrate, fat and micronutrient intake
Detailed 3-day calorie, carbohydrate, fat and micronutrient intake via Intake24 online questionnaire
Measured: 15 minutes/ history diary intake
Assess eating behaviour
Child Eating Behaviour, (CEBQ) questionnaire
Measured: 10 minutes
Assess eating behaviour
Child Tree-Factor Eating Questionnaire (CTFEQr17) questionnaire
Measured: 10 minutes
Post-prandial protein digestibility
Postprandial plasma AA appearance/digestibility via collection of blood sample
Measured: 360 minutes
Assess body composition
Whole-body muscle mass using 3T
Measured: 30 minutes
Assess body composition
Whole-body muscle mass using 3T
Measured: Assess body composition
Measure serum inflammatory cytokines
Serum key cytokines and hormones: IL-1, IL-6, IL-10, IL-15, TNF, GH, IGF-1, testosterone
Measured: 15 minutes
Quantify muscle strength
Muscle strength will be assessed via maximal forearm contractions using a handgrip dynamometer
Measured: 30 minutes
Assess body composition
Intra-myocellular and extra-myocellular lipid content using 3T
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start20 Jul 2022
- Primary completion28 Dec 2022 (estimated)
- Study completion25 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gordon Moran, PhD, Principal investigator, University of NottinghamKostas Tsintzas, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572008
- Sponsor's protocol ID
- 297431
- Acronym
- PINC
- Status last verified
- Oct 2022
- First submitted
- 13 Sep 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 18478564van 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.
PubMed 24332699Gassull 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.
PubMed 11706295Filippi J, Al-Jaouni R, Wiroth JB, Hebuterne X, Schneider SM. Nutritional deficiencies in patients with Crohn's disease in remission. Inflamm Bowel Dis. 2006 Mar;12(3):185-91. doi: 10.1097/01.MIB.0000206541.15963.c3.
PubMed 16534419Lochs H, Dejong C, Hammarqvist F, Hebuterne X, Leon-Sanz M, Schutz T, van Gemert W, van Gossum A, Valentini L; DGEM (German Society for Nutritional Medicine); Lubke H, Bischoff S, Engelmann N, Thul P; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Gastroenterology. Clin Nutr. 2006 Apr;25(2):260-74. doi: 10.1016/j.clnu.2006.01.007. Epub 2006 May 15.
PubMed 16698129Wardle RA, Thapaliya G, Nowak A, Radford S, Dalton M, Finlayson G, Moran GW. An Examination of Appetite and Disordered Eating in Active Crohn's Disease. J Crohns Colitis. 2018 Jun 28;12(7):819-825. doi: 10.1093/ecco-jcc/jjy041.
PubMed 29617753Davies 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.
PubMed 31178247Khalaf A, Hoad CL, Menys A, Nowak A, Radford S, Taylor SA, Latief K, Lingaya M, Falcone Y, Singh G, Spiller RC, Gowland PA, Marciani L, Moran GW. Gastrointestinal peptides and small-bowel hypomotility are possible causes for fasting and postprandial symptoms in active Crohn's disease. Am J Clin Nutr. 2020 Jan 1;111(1):131-140. doi: 10.1093/ajcn/nqz240.
PubMed 31557279Hisamatsu T, Okamoto S, Hashimoto M, Muramatsu T, Andou A, Uo M, Kitazume MT, Matsuoka K, Yajima T, Inoue N, Kanai T, Ogata H, Iwao Y, Yamakado M, Sakai R, Ono N, Ando T, Suzuki M, Hibi T. Novel, objective, multivariate biomarkers composed of plasma amino acid profiles for the diagnosis and assessment of inflammatory bowel disease. PLoS One. 2012;7(1):e31131. doi: 10.1371/journal.pone.0031131. Epub 2012 Jan 31.
PubMed 22303484Moughan 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.
PubMed 31529051Koopman 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.
PubMed 19625697Tsintzas K, Jones R, Pabla P, Mallinson J, Barrett DA, Kim DH, Cooper S, Davies A, Taylor T, Chee C, Gaffney C, van Loon LJC, Stephens FB. Effect of acute and short-term dietary fat ingestion on postprandial skeletal muscle protein synthesis rates in middle-aged, overweight, and obese men. Am J Physiol Endocrinol Metab. 2020 Mar 1;318(3):E417-E429. doi: 10.1152/ajpendo.00344.2019. Epub 2020 Jan 7.
PubMed 31910028Koopman R, Crombach N, Gijsen AP, Walrand S, Fauquant J, Kies AK, Lemosquet S, Saris WH, Boirie Y, van Loon LJ. Ingestion of a protein hydrolysate is accompanied by an accelerated in vivo digestion and absorption rate when compared with its intact protein. Am J Clin Nutr. 2009 Jul;90(1):106-15. doi: 10.3945/ajcn.2009.27474. Epub 2009 May 27.
PubMed 19474134Boirie Y, Fauquant J, Rulquin H, Maubois JL, Beaufrere B. Production of large amounts of [13C]leucine-enriched milk proteins by lactating cows. J Nutr. 1995 Jan;125(1):92-8. doi: 10.1093/jn/125.1.92.
PubMed 7815181Bradley J, Simpson E, Poliakov I, Matthews JN, Olivier P, Adamson AJ, Foster E. Comparison of INTAKE24 (an Online 24-h Dietary Recall Tool) with Interviewer-Led 24-h Recall in 11-24 Year-Old. Nutrients. 2016 Jun 9;8(6):358. doi: 10.3390/nu8060358.
PubMed 27294952
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Protein Nutrition in Paediatric Crohn's Disease
- ClinicalTrials.gov ID
- NCT05572008
- Acronym / sponsor ID
- PINC / 297431
- 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)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 28 Dec 2022 (estimated)
- Study completion
- 25 May 2023 (estimated)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paediatric Crohn's disease | Experimental | Behavioral: Protein nutrition in paediatric Crohn's diseaseCD young population (ages 12-17 years) - N=20 |
| Healthy volunteers | Active comparator | Behavioral: Protein nutrition in paediatric Crohn's diseaseAge-, BMI- and gender-matched healthy volunteers (HV) - N=20 |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein nutrition in paediatric Crohn's diseaseAll 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 | Behavioural | Healthy volunteers, paediatric Crohn's disease |
Primary outcome
Assess protein intake
Time frame: 15 minutes/ history diary intake
Detailed 3-days protein intake via Intake24 online questionnaire
9 secondary outcomes
Assess calories, carbohydrate, fat and micronutrient intake
Time frame: 15 minutes/ history diary intake
Assess eating behaviour
Time frame: 10 minutes
Assess eating behaviour
Time frame: 10 minutes
Post-prandial protein digestibility
Time frame: 360 minutes
Assess body composition
Time frame: 30 minutes
Assess body composition
Time frame: Assess body composition
Measure serum inflammatory cytokines
Time frame: 15 minutes
Quantify muscle strength
Time frame: 30 minutes
Assess body composition
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Background: PubMed 18478564Schneider 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.
- Background: PubMed 24332699van 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.
- Background: PubMed 11706295Gassull 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.
- Background: PubMed 16534419Filippi J, Al-Jaouni R, Wiroth JB, Hebuterne X, Schneider SM. Nutritional deficiencies in patients with Crohn's disease in remission. Inflamm Bowel Dis. 2006 Mar;12(3):185-91. doi: 10.1097/01.MIB.0000206541.15963.c3.
- Background: PubMed 16698129Lochs H, Dejong C, Hammarqvist F, Hebuterne X, Leon-Sanz M, Schutz T, van Gemert W, van Gossum A, Valentini L; DGEM (German Society for Nutritional Medicine); Lubke H, Bischoff S, Engelmann N, Thul P; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Gastroenterology. Clin Nutr. 2006 Apr;25(2):260-74. doi: 10.1016/j.clnu.2006.01.007. Epub 2006 May 15.
- Background: PubMed 29617753Wardle RA, Thapaliya G, Nowak A, Radford S, Dalton M, Finlayson G, Moran GW. An Examination of Appetite and Disordered Eating in Active Crohn's Disease. J Crohns Colitis. 2018 Jun 28;12(7):819-825. doi: 10.1093/ecco-jcc/jjy041.
- Background: PubMed 31178247Davies 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.
- Background: PubMed 31557279Khalaf A, Hoad CL, Menys A, Nowak A, Radford S, Taylor SA, Latief K, Lingaya M, Falcone Y, Singh G, Spiller RC, Gowland PA, Marciani L, Moran GW. Gastrointestinal peptides and small-bowel hypomotility are possible causes for fasting and postprandial symptoms in active Crohn's disease. Am J Clin Nutr. 2020 Jan 1;111(1):131-140. doi: 10.1093/ajcn/nqz240.
- Background: PubMed 22303484Hisamatsu T, Okamoto S, Hashimoto M, Muramatsu T, Andou A, Uo M, Kitazume MT, Matsuoka K, Yajima T, Inoue N, Kanai T, Ogata H, Iwao Y, Yamakado M, Sakai R, Ono N, Ando T, Suzuki M, Hibi T. Novel, objective, multivariate biomarkers composed of plasma amino acid profiles for the diagnosis and assessment of inflammatory bowel disease. PLoS One. 2012;7(1):e31131. doi: 10.1371/journal.pone.0031131. Epub 2012 Jan 31.
- Background: PubMed 31529051Moughan 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.
- Background: PubMed 19625697Koopman 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.
- Background: PubMed 31910028Tsintzas K, Jones R, Pabla P, Mallinson J, Barrett DA, Kim DH, Cooper S, Davies A, Taylor T, Chee C, Gaffney C, van Loon LJC, Stephens FB. Effect of acute and short-term dietary fat ingestion on postprandial skeletal muscle protein synthesis rates in middle-aged, overweight, and obese men. Am J Physiol Endocrinol Metab. 2020 Mar 1;318(3):E417-E429. doi: 10.1152/ajpendo.00344.2019. Epub 2020 Jan 7.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon Moran, PhD principal investigator
University of Nottingham
Kostas Tsintzas, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein nutrition in paediatric Crohn's disease in people with Crohn Disease, run by University of Nottingham at 1 site in United Kingdom.
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 6 inclusion and 6 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 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Bayan Aljilani, MSc (07866010685, mzxba1@exmail.nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess protein intake (time frame: 15 minutes/ history diary intake). 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 NCT05572008, which also lists 19 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 7 Oct 2022.