Inflammatory Bowel DiseasesPACSNCT05572203
Phenotyping of Adult Crohn's Focusing on Sarcopenia
A study testing Intrinsically labelled protein in people with Inflammatory Bowel Diseases and Sarcopenia, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Inflammatory bowel disease (IBD) includes two idiopathic chronic relapsing and remitting inflammatory conditions affecting the gastrointestinal (GI) tract: Crohn's disease (CD) and ulcerative colitis (UC)Malnutrition and significant alteration of body composition are common in inflammatory bowel disease patients… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Sarcopenia, Digestive System Disease
- What is being tested?
- Intrinsically labelled protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Apr 2022to 1 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- BMI <30 kg/m2/
- No previous known bowel disease
- Be able to provide written informed consent \& participate fully in all aspects of the study.
- Aged 18 years or older.
- BMI <30 kg/m2
Show all 12Show fewer
- Documented diagnosis of CD previously confirmed by endoscopy and histology at least 2 years prior to enrolment.
- Active CD defined as HBI >4 and CRP >5g/l or FCP >250ug/g or as deemed through endoscopy or cross sectional imaging.
- Previous biologic or immunosuppressant exposure
- Previous CD-related intestinal surgery
- Able to participate fully in all aspects of the study
- Written informed consent obtained and documented
Who cannot join
- Aged 18 years or older
- BMI <30 kg/m2/
- No previous known bowel disease
- Be able to provide written informed consent \& participate fully in all aspects of the study.
- A current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, or diverticular disease-associated colitis
- A diagnosis of short-bowel syndrome
Show all 12Show fewer
- Use of systemic corticosteroids for CD (2 continuous weeks or more) within 3 months prior to enrolment, or use of any medications for HVs and CD, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study.
- 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.
- History of active alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures.
- Pregnancy or breastfeeding.
- Contraindications for DEXAscanning e.g. x-ray within last 7 days.
- Allergy to milk, , or casein
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Nutritional Phenotyping of Adult Crohn's Disease Patients: a Focus on Protein Intake and Sarcopenia
Inflammatory bowel disease (IBD) includes two idiopathic chronic relapsing and remitting inflammatory conditions affecting the gastrointestinal (GI) tract: Crohn's disease (CD) and ulcerative colitis (UC)Malnutrition and significant alteration of body composition are common in inflammatory bowel disease patients, whereby the prevalence of malnutrition may be up to 82.8% in CD patients with active disease, and up to 38.9% in CD patients in remission. Many CD patients have low muscle mass and function (sarcopenia) with drivers of such pathophysiology unknown. 41.6% of CD patients with sarcopenia require surgery, with the surgical trauma and resulting inactivity leading to further muscle mass loss such that the chronic inflammatory insult associated with refractory disease may be linked to advanced muscle mass depletion. The majority of adult CD patients have low muscle mass even in clinical remission indicating the poorly reversible nature of this phenomenon. Chronic disease burden may therefore be important in the accentuation of muscle loss.
Muscle mass is maintained through the daily balance of 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. Patients with active CD show a significant decrease in the expression of proteins in hypertrophic signalling pathways (Akt, P70S6K1) with no change in the expression of atrophic signalling (MAFbx, MuRF1). Also, adult CD patients with established disease consume less protein compared to matched healthy volunteers (HV). Furthermore, the intestinal motility, measured using cine-MRI, is reduced in active CD, possibly further decreasing intestinal digestion and absorption of dietary peptides. In general, the malabsorption is a major contributing factor to malnourishment in CD. It has been shown that in male paediatric patients with long-term CD, muscle metabolism is perturbed by a negative branched-chain amino acid balance in the forearm, with this variable linked to lower appendicular muscle mass, higher muscle fatigue and reduced protein intake, CD may have a significant effect on protein digestion and absorption, and blunt the MPS response to feeding, leading to a chronic muscle mass reduction that may persist even when in remission.
Read more
The EAA components of a protein meal are crucial for the stimulation of muscle protein synthesis (MPS), and all the EAA/leucine play a key role in driving MPS. Low serum levels EAA/leucine have been reported in CD but their role in the aetiology of sarcopenia in CD is unknown.
Further, how CD affects the protein digestion/absorption and how this contributes to low EAA/leucine unclear. Recent advances in stable isotope tracer techniques using a dual tracer methodology 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. Further, by collecting a muscle biopsy postprandially, the direct incorporation of AA from the digested protein into the muscle can be determined- providing a gold standard method for investigating anabolic resistance.
Project aim is to use an intrinsically labelled casein to investigate protein digestion, absorption and MPS responses in CD patients.
To achieve this, investigators will investigate protein digestion, absorption and muscle protein synthesis responses in Crohn's disease patients and healthy volunteers by utilising intrinsically labelled protein.
- Conditions
- Inflammatory Bowel Diseases, Sarcopenia, Digestive System Disease, Nutrition, Healthy, Protein Malabsorption, Crohn Disease
- Being tested
- Intrinsically labelled protein
- Keywords
- Labelled protein, protein, muscle protein synthesis, muscle mass, sarcopenia, Inflammatory bowel disease, Crohn's disease, nutrition, DEXA, 13C/2H-labelled amino acids
- Medical subject headings
- Inflammatory Bowel Diseases, Sarcopenia, Digestive System Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrinsically labelled proteinDietary supplement
Also called Intrinsically labelled Casein
It is a protein drink that includes Intrinsically labelled Casein ( from Arla Foods), 13C/2H-labelled Spirulina (from CK Isotopes), and 13C/2H-labelled amino acids (from CK Isotopes)
| Study group | Role | What they receive |
|---|---|---|
| Healthy group (Control group ) | Active comparator | This group will include healthy participants matching Crohn's group Receives: Dietary Supplement: Intrinsically labelled protein |
| Crohn's group or patients group | Experimental | This group will include patients with Crohn's disease. Receives: Dietary Supplement: Intrinsically labelled protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial muscle protein synthesis.
Postprandial muscle bound [ring-D5]-Phenylalanine, [5,5,5-D3]-Leucine as measured through mass spectrometry
Measured: Change from baseline 4 hours (Two time points)
Secondary outcomes (20)
Appearance/ digestibility of plasma Amino Acid in blood.
Postprandial plasma [ring-D5]-Phenylalanine, [5,5,5-D3]-Leucine as measured through mass spectrometry
Measured: blood samples will be taken at regular intervals up to 240 minutes (max 120ml total blood draw post protein drink). 12-time points
Muscle mRNA expression of anabolic and catabolic
The mRNA expression of transcripts involved anabolic and catabolic signalling pathways as measured through RT-qPCR (Applied Biosystems).
Measured: Change from baseline at 4 hours (Two time points).
Muscle protein expression of anabolic and catabolic pathway.
Muscle protein expression of anabolic and catabolic pathway signalling proteins
Measured: Change from baseline at 4 hours (Two time points).
Serum Cytokines levels of IL-1
As measured using ELISAs
Measured: Only at baseline.
Serum Cytokines levels of IL-6
As measured using ELISAs
Measured: Only at baseline.
Serum Cytokines levels of IL-10
As measured using ELISAs
Measured: Only at baseline.
Serum Cytokines levels of CRP
As measured using ELISAs (IBDQ)
Measured: Only at baseline.
Serum Cytokines levels of TNF
Daily energy intake and dietary macronutrient composition
Measured: Only at baseline.
Appendicular Lean Mass (ALM) to Height Ratio (Kg/Height2) through DEXA scan
- It will be assessed via DEXA scan using a GE Lunar Prodigy DEXA scanner housed in the University of Nottingham's David Greenfield unit. The scan will be a whole-body scan for total body composition measurement including ALM to height. The scans will be analysed using the scanners inbuilt Corescan software. Regional measurements will be taken post scan using custom analysis functions within the Corescan software.
Measured: Only at baseline
Appendicular skeletal muscle index (ASMI; kg/m2) through DEXA scan.
It will be assessed via DEXA scan using a GE Lunar Prodigy DEXA scanner housed in the University of Nottingham's David Greenfield unit. The scan will be a whole-body scan for total body composition measurement including ASMI. The scans will be analysed using the scanners inbuilt Corescan software. Regional measurements will be taken post scan using custom analysis functions within the Corescan software
Measured: Only at baseline
Skeletal muscle index (SMI; kg/m2) through DEXA scan.
It will be assessed via DEXA scan using a GE Lunar Prodigy DEXA scanner housed in the University of Nottingham's David Greenfield unit. The scan will be a whole-body scan for total body composition measurement including SMI. The scans will be analysed using the scanners inbuilt Corescan software. Regional measurements will be taken post scan using custom analysis functions within the Corescan software.
Measured: Only at baseline
Skeletal Muscle Mass Percentage (SMM; %) through DEXA scan.
It will be assessed via DEXA scan using a GE Lunar Prodigy DEXA scanner housed in the University of Nottingham's David Greenfield unit. The scans will be analysed using the scanners inbuilt Corescan software. Regional measurements will be taken post scan using custom analysis functions within the Corescan software.
Measured: Only at baseline
Total Body Fat Percentage (BF; %) through DEXA scan.
It will be assessed via DEXA scan using a GE Lunar Prodigy DEXA scanner housed in the University of Nottingham's David Greenfield unit. The scans will be analysed using the scanners inbuilt Corescan software. Regional measurements will be taken post scan using custom analysis functions within the Corescan software.
Measured: Only at baseline
Fat Mass Index (FMI; kg/m2) through DEXA scan.
It will be assessed via DEXA scan using a GE Lunar Prodigy DEXA scanner housed in the University of Nottingham's David Greenfield unit. The scans will be analysed using the scanners inbuilt Corescan software. Regional measurements will be taken post scan using custom analysis functions within the Corescan software.
Measured: Only at baseline
Resting Metabolic Rate (RMR) through DEXA scan.
It will be assessed via DEXA scan using a GE Lunar Prodigy DEXA scanner housed in the University of Nottingham's David Greenfield unit. The scans will be analysed using the scanners inbuilt Corescan software. Regional measurements will be taken post scan using custom analysis functions within the Corescan software.
Measured: Only at baseline
Muscle Strength through Handgrip
Handgrip Dynamometers are instruments for measuring the maximum isometric strength of the hand and forearm muscles
Measured: Only at baseline
Muscle Strength through Cybex Dynamometer
A CYBEX Isokinetic Test is used to measure the maximum strength of a joint throughout its available range-of-motion (ROM).
Measured: Only at baseline
Daily physical activity
Physical activity as measured with IPAQ
Measured: Only at baseline
Quality of life for Crohn's disease patients
measured through the Short Quality of Life Questionnaire for Inflammatory Bowel Disease
Measured: Only at baseline
Dietary intake of one day before the experiment day.
As analysed by using intake24 website; https://intake24.co.uk/info/output . The participant will be received email included the link to fill it by what they intake on this day.
Measured: Only at baseline
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 start14 Apr 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572203
- Sponsor's protocol ID
- 21044
- Other IDs
- 287471
- Acronym
- PACS
- Status last verified
- Dec 2022
- First submitted
- 26 Jul 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Benjamin J, Makharia GK, Kalaivani M, Joshi YK. Nutritional status of patients with Crohn's disease. Indian J Gastroenterol. 2008 Sep-Oct;27(5):195-200.
PubMed 19112190Brook MS, Wilkinson DJ, Phillips BE, Perez-Schindler J, Philp A, Smith K, Atherton PJ. Skeletal muscle homeostasis and plasticity in youth and ageing: impact of nutrition and exercise. Acta Physiol (Oxf). 2016 Jan;216(1):15-41. doi: 10.1111/apha.12532. Epub 2015 Jun 21.
PubMed 26010896Bukhari SS, Phillips BE, Wilkinson DJ, Limb MC, Rankin D, Mitchell WK, Kobayashi H, Greenhaff PL, Smith K, Atherton PJ. Intake of low-dose leucine-rich essential amino acids stimulates muscle anabolism equivalently to bolus whey protein in older women at rest and after exercise. Am J Physiol Endocrinol Metab. 2015 Jun 15;308(12):E1056-65. doi: 10.1152/ajpendo.00481.2014. Epub 2015 Mar 31.
PubMed 25827594Chiba T, Suzuki K, Matsumoto T. Plasma-Free Amino Acid Profiles in Crohn's Disease: Relationship With the Crohn Disease Activity Index. Clin Med Insights Gastroenterol. 2018 Jul 30;11:1179552218791173. doi: 10.1177/1179552218791173. eCollection 2018.
PubMed 30083065Cuthbertson D, Smith K, Babraj J, Leese G, Waddell T, Atherton P, Wackerhage H, Taylor PM, Rennie MJ. Anabolic signaling deficits underlie amino acid resistance of wasting, aging muscle. FASEB J. 2005 Mar;19(3):422-4. doi: 10.1096/fj.04-2640fje. Epub 2004 Dec 13.
PubMed 15596483Dalton M, Blundell J, Finlayson GS. Examination of food reward and energy intake under laboratory and free-living conditions in a trait binge eating subtype of obesity. Front Psychol. 2013 Oct 21;4:757. doi: 10.3389/fpsyg.2013.00757. eCollection 2013.
PubMed 24155732Davies 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 31178247Devi S, Varkey A, Sheshshayee MS, Preston T, Kurpad AV. Measurement of protein digestibility in humans by a dual-tracer method. Am J Clin Nutr. 2018 Jun 1;107(6):984-991. doi: 10.1093/ajcn/nqy062.
PubMed 29771297Hartman C, Eliakim R, Shamir R. Nutritional status and nutritional therapy in inflammatory bowel diseases. World J Gastroenterol. 2009 Jun 7;15(21):2570-8. doi: 10.3748/wjg.15.2570.
PubMed 19496185Khalaf A, Nowak A, Menys A, Marciani L, Taylor SA, Spiller RC, Gowland PA, Moran GW, Hoad CL. Cine MRI assessment of motility in the unprepared small bowel in the fasting and fed state: Beyond the breath-hold. Neurogastroenterol Motil. 2019 Jan;31(1):e13466. doi: 10.1111/nmo.13466. Epub 2018 Sep 19.
PubMed 30230099Li S, Ney M, Eslamparast T, Vandermeer B, Ismond KP, Kroeker K, Halloran B, Raman M, Tandon P. Systematic review of nutrition screening and assessment in inflammatory bowel disease. World J Gastroenterol. 2019 Jul 28;25(28):3823-3837. doi: 10.3748/wjg.v25.i28.3823.
PubMed 31391776Moshfegh AJ, Rhodes DG, Baer DJ, Murayi T, Clemens JC, Rumpler WV, Paul DR, Sebastian RS, Kuczynski KJ, Ingwersen LA, Staples RC, Cleveland LE. The US Department of Agriculture Automated Multiple-Pass Method reduces bias in the collection of energy intakes. Am J Clin Nutr. 2008 Aug;88(2):324-32. doi: 10.1093/ajcn/88.2.324.
PubMed 18689367Moughan 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 31529051Neurath MF. Cytokines in inflammatory bowel disease. Nat Rev Immunol. 2014 May;14(5):329-42. doi: 10.1038/nri3661. Epub 2014 Apr 22.
PubMed 24751956Pizzoferrato M, de Sire R, Ingravalle F, Mentella MC, Petito V, Martone AM, Landi F, Miggiano GAD, Mele MC, Lopetuso LR, Schiavoni E, Napolitano D, Turchini L, Poscia A, Nicolotti N, Papa A, Armuzzi A, Scaldaferri F, Gasbarrini A. Characterization of Sarcopenia in an IBD Population Attending an Italian Gastroenterology Tertiary Center. Nutrients. 2019 Sep 24;11(10):2281. doi: 10.3390/nu11102281.
PubMed 31554166
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Nutritional Phenotyping of Adult Crohn's Disease Patients: a Focus on Protein Intake and Sarcopenia
- ClinicalTrials.gov ID
- NCT05572203
- Acronym / sponsor ID
- PACS / 21044
- Conditions
- Inflammatory Bowel Diseases, Sarcopenia, Digestive System Disease, Nutrition, Healthy, Protein Malabsorption, Crohn Disease
- Keywords
- Labelled protein, protein, muscle protein synthesis, muscle mass, sarcopenia, Inflammatory bowel disease, Crohn's disease, nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Dec 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.
Inflammatory bowel disease (IBD) includes two idiopathic chronic relapsing and remitting inflammatory conditions affecting the gastrointestinal (GI) tract: Crohn's disease (CD) and ulcerative colitis (UC)Malnutrition and significant alteration of body composition are common in inflammatory bowel disease patients, whereby the prevalence of malnutrition may be up to 82.8% in CD patients with active disease, and up to 38.9% in CD patients in remission. Many CD patients have low muscle mass and function (sarcopenia) with drivers of such pathophysiology unknown. 41.6% of CD patients with sarcopenia require surgery, with the surgical trauma and resulting inactivity leading to further muscle mass loss such that the chronic inflammatory insult associated with refractory disease may be linked to advanced muscle mass depletion. The majority of adult CD patients have low muscle mass even in clinical remission indicating the poorly reversible nature of this phenomenon. Chronic disease burden may therefore be important in the accentuation of muscle loss.
Muscle mass is maintained through the daily balance of 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. Patients with active CD show a significant decrease in the expression of proteins in hypertrophic signalling pathways (Akt, P70S6K1) with no change in the expression of atrophic signalling (MAFbx, MuRF1). Also, adult CD patients with established disease consume less protein compared to matched healthy volunteers (HV). Furthermore, the intestinal motility, measured using cine-MRI, is reduced in active CD, possibly further decreasing intestinal digestion and absorption of dietary peptides. In general, the malabsorption is a major contributing factor to malnourishment in CD. It has been shown that in male paediatric patients with long-term CD, muscle metabolism is perturbed by a negative branched-chain amino acid balance in the forearm, with this variable linked to lower appendicular muscle mass, higher muscle fatigue and reduced protein intake, CD may have a significant effect on protein digestion and absorption, and blunt the MPS response to feeding, leading to a chronic muscle mass reduction that may persist even when in remission.
The EAA components of a protein meal are crucial for the stimulation of muscle protein synthesis (MPS), and all the EAA/leucine play a key role in driving MPS. Low serum levels EAA/leucine have been reported in CD but their role in the aetiology of sarcopenia in CD is unknown.
Further, how CD affects the protein digestion/absorption and how this contributes to low EAA/leucine unclear. Recent advances in stable isotope tracer techniques using a dual tracer methodology 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. Further, by collecting a muscle biopsy postprandially, the direct incorporation of AA from the digested protein into the muscle can be determined- providing a gold standard method for investigating anabolic resistance.
Project aim is to use an intrinsically labelled casein to investigate protein digestion, absorption and MPS responses in CD patients.
To achieve this, investigators will investigate protein digestion, absorption and muscle protein synthesis responses in Crohn's disease patients and healthy volunteers by utilising intrinsically labelled protein.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy group (Control group ) | Active comparator | Dietary Supplement: Intrinsically labelled proteinThis group will include healthy participants matching Crohn's group |
| Crohn's group or patients group | Experimental | Dietary Supplement: Intrinsically labelled proteinThis group will include patients with Crohn's disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aged 18 years or older
- BMI <30 kg/m2/
- No previous known bowel disease
- Be able to provide written informed consent \& participate fully in all aspects of the study.
- Aged 18 years or older.
Key exclusion criteria (12 listed)
- Aged 18 years or older
- BMI <30 kg/m2/
- No previous known bowel disease
- Be able to provide written informed consent \& participate fully in all aspects of the study.
- A current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, or diverticular disease-associated colitis
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 |
|---|---|---|
| Intrinsically labelled proteinAlso: Intrinsically labelled CaseinIt is a protein drink that includes Intrinsically labelled Casein ( from Arla Foods), 13C/2H-labelled Spirulina (from CK Isotopes), and 13C/2H-labelled amino acids (from CK Isotopes) | Dietary supplement | Crohn's group or patients group, Healthy group (Control group ) |
Primary outcome
Postprandial muscle protein synthesis.
Time frame: Change from baseline 4 hours (Two time points)
Postprandial muscle bound [ring-D5]-Phenylalanine, [5,5,5-D3]-Leucine as measured through mass spectrometry
20 secondary outcomes
Appearance/ digestibility of plasma Amino Acid in blood.
Time frame: blood samples will be taken at regular intervals up to 240 minutes (max 120ml total blood draw post protein drink). 12-time points
Muscle mRNA expression of anabolic and catabolic
Time frame: Change from baseline at 4 hours (Two time points).
Muscle protein expression of anabolic and catabolic pathway.
Time frame: Change from baseline at 4 hours (Two time points).
Serum Cytokines levels of IL-1
Time frame: Only at baseline.
Serum Cytokines levels of IL-6
Time frame: Only at baseline.
Serum Cytokines levels of IL-10
Time frame: Only at baseline.
Serum Cytokines levels of CRP
Time frame: Only at baseline.
Serum Cytokines levels of TNF
Time frame: Only at baseline.
Appendicular Lean Mass (ALM) to Height Ratio (Kg/Height2) through DEXA scan
Time frame: Only at baseline
Appendicular skeletal muscle index (ASMI; kg/m2) through DEXA scan.
Time frame: Only at baseline
Skeletal muscle index (SMI; kg/m2) through DEXA scan.
Time frame: Only at baseline
Skeletal Muscle Mass Percentage (SMM; %) through DEXA scan.
Time frame: Only at baseline
Total Body Fat Percentage (BF; %) through DEXA scan.
Time frame: Only at baseline
Fat Mass Index (FMI; kg/m2) through DEXA scan.
Time frame: Only at baseline
Resting Metabolic Rate (RMR) through DEXA scan.
Time frame: Only at baseline
Muscle Strength through Handgrip
Time frame: Only at baseline
Muscle Strength through Cybex Dynamometer
Time frame: Only at baseline
Daily physical activity
Time frame: Only at baseline
Quality of life for Crohn's disease patients
Time frame: Only at baseline
Dietary intake of one day before the experiment day.
Time frame: Only at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Background: PubMed 19112190Benjamin J, Makharia GK, Kalaivani M, Joshi YK. Nutritional status of patients with Crohn's disease. Indian J Gastroenterol. 2008 Sep-Oct;27(5):195-200.
- Background: PubMed 26010896Brook MS, Wilkinson DJ, Phillips BE, Perez-Schindler J, Philp A, Smith K, Atherton PJ. Skeletal muscle homeostasis and plasticity in youth and ageing: impact of nutrition and exercise. Acta Physiol (Oxf). 2016 Jan;216(1):15-41. doi: 10.1111/apha.12532. Epub 2015 Jun 21.
- Background: PubMed 25827594Bukhari SS, Phillips BE, Wilkinson DJ, Limb MC, Rankin D, Mitchell WK, Kobayashi H, Greenhaff PL, Smith K, Atherton PJ. Intake of low-dose leucine-rich essential amino acids stimulates muscle anabolism equivalently to bolus whey protein in older women at rest and after exercise. Am J Physiol Endocrinol Metab. 2015 Jun 15;308(12):E1056-65. doi: 10.1152/ajpendo.00481.2014. Epub 2015 Mar 31.
- Background: PubMed 30083065Chiba T, Suzuki K, Matsumoto T. Plasma-Free Amino Acid Profiles in Crohn's Disease: Relationship With the Crohn Disease Activity Index. Clin Med Insights Gastroenterol. 2018 Jul 30;11:1179552218791173. doi: 10.1177/1179552218791173. eCollection 2018.
- Background: PubMed 15596483Cuthbertson D, Smith K, Babraj J, Leese G, Waddell T, Atherton P, Wackerhage H, Taylor PM, Rennie MJ. Anabolic signaling deficits underlie amino acid resistance of wasting, aging muscle. FASEB J. 2005 Mar;19(3):422-4. doi: 10.1096/fj.04-2640fje. Epub 2004 Dec 13.
- Background: PubMed 24155732Dalton M, Blundell J, Finlayson GS. Examination of food reward and energy intake under laboratory and free-living conditions in a trait binge eating subtype of obesity. Front Psychol. 2013 Oct 21;4:757. doi: 10.3389/fpsyg.2013.00757. eCollection 2013.
- 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 29771297Devi S, Varkey A, Sheshshayee MS, Preston T, Kurpad AV. Measurement of protein digestibility in humans by a dual-tracer method. Am J Clin Nutr. 2018 Jun 1;107(6):984-991. doi: 10.1093/ajcn/nqy062.
- Background: PubMed 19496185Hartman C, Eliakim R, Shamir R. Nutritional status and nutritional therapy in inflammatory bowel diseases. World J Gastroenterol. 2009 Jun 7;15(21):2570-8. doi: 10.3748/wjg.15.2570.
- Background: PubMed 30230099Khalaf A, Nowak A, Menys A, Marciani L, Taylor SA, Spiller RC, Gowland PA, Moran GW, Hoad CL. Cine MRI assessment of motility in the unprepared small bowel in the fasting and fed state: Beyond the breath-hold. Neurogastroenterol Motil. 2019 Jan;31(1):e13466. doi: 10.1111/nmo.13466. Epub 2018 Sep 19.
- Background: PubMed 31391776Li S, Ney M, Eslamparast T, Vandermeer B, Ismond KP, Kroeker K, Halloran B, Raman M, Tandon P. Systematic review of nutrition screening and assessment in inflammatory bowel disease. World J Gastroenterol. 2019 Jul 28;25(28):3823-3837. doi: 10.3748/wjg.v25.i28.3823.
- Background: PubMed 18689367Moshfegh AJ, Rhodes DG, Baer DJ, Murayi T, Clemens JC, Rumpler WV, Paul DR, Sebastian RS, Kuczynski KJ, Ingwersen LA, Staples RC, Cleveland LE. The US Department of Agriculture Automated Multiple-Pass Method reduces bias in the collection of energy intakes. Am J Clin Nutr. 2008 Aug;88(2):324-32. doi: 10.1093/ajcn/88.2.324.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrinsically labelled protein in people with Inflammatory Bowel Diseases and Sarcopenia, 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 12 inclusion and 12 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 8 Dec 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial muscle protein synthesis. (time frame: Change from baseline 4 hours (Two time points)). 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 NCT05572203, which also lists 21 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 8 Dec 2022.