UndernutritionCARBOPTIMUSNCT03867006
Optimization of the Preservation of Muscle Mass and / or Its Recovery by a Protein-energy Chrononutrition Approach Dissociated From Meals
A study testing Protein and Protein and Carbohydrate in people with Undernutrition, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
Trial summary
Muscle wasting has a multifactorial origin, including decreased physical activity, malnutrition, loss of post-incident muscle recovery abilities, and decreased ability to regenerate muscle. Among the strategies tested to improve the production of proteins and thus muscle is the supplementation of whey proteins. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Undernutrition
- What is being tested?
- Protein and Protein and Carbohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesFrance
- Study dates
- 8 Feb 2019to 31 Oct 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Resident on the Accommodation Establishments for Dependent Elderly Persons on the Mutuality of Loire, France
- Risk of undernutrition or moderate undernutrition with one of the following criteria :
- Either 5-10% of weight loss in 1 month or 10-15% in 6 months.
- Or Body Mass Index (BMI) between 16 and 21
- Or Albumin levels between 30 and 35 g/L
- Or global Mini Nutritional Assessment (MNA) test between 17 and 23.5
- Or Short Emergency Geriatric Assessment (SEGA) Score >8
Who cannot join
- Sub-acute pathology (flu, gastroenteritis, bacterial infections ...) or trauma (fracture, surgery ...) in the 30 days prior to inclusion.
- Hepatocellular insufficiency
- Heart failure with decompensation
- Severe dementia,
- Insulin-treated diabetes
- Renal insufficiency (clearance <30 ml / min)
Show all 11Show fewer
- Long-term cortico-therapy
- Cancer undergoing chemotherapy treatment or/and radiotherapy
- Gastrointestinal pathology,
- Diet incompatible with the nutritional protocol (intolerance to milk or lactose, vegetarians, vegans, ...)
- Motor disability leading to the impossibility of doing muscle function tests.
Trial locations and contacts
3 sites in 1 country.
France3 sites
EHPAD Cité des Aînés
Saint-Etienne
EHPAD La Cerisaie
Saint-Etienne
EHPAD Le Soleil
Saint-Etienne
About this study
Muscle wasting has a multifactorial origin, including decreased physical activity, malnutrition, loss of post-incident muscle recovery abilities, and decreased ability to regenerate muscle. Among the strategies tested to improve the production of proteins and thus muscle is the supplementation of whey proteins. However this strategy does not seem sufficient and optimal to avoid muscle wasting and it must be complemented by a complementary action.
Muscle protein degradation also occurs during the nocturnal fasting periods to provide amino acids for energy purposes and to produce glucose, essential for vital organs. The preservation of the benefit of whey intake during meals could therefore be optimized by reducing the use of muscle proteins for energy purposes during the night.
Read the detailed description
In this study, three arms will be studied for 3 months: 1 control group, 1 group with whey supplementation at lunch, and 1 group with whey supplementation at lunch and an energy bolus before bedtime. Actions include weight and body composition monitoring, nutritional status and muscle function, as well as mechanistic.
- Conditions
- Undernutrition
- Being tested
- Protein, Protein and Carbohydrate
- Keywords
- Malnutrition, Undernutrition, Elderly, Protein, Carbohydrate
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProteinDietary supplement
In addition to their normal meal, patients will eat 30g of whey protein every lunch during 90 days.
Protein and CarbohydrateDietary supplement
In addition to their normal meal, patients will eat 30g of whey protein every lunch during 90 days and eat 60g of carbohydrates 2h after every diner during 90 days.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Patients will be randomized in the control group. They will have test MNA (Mini Nutritional Assessment), frailty screening tool (questionnaire FiND), clinical examination, blood sample, blood sample with heparin, white blood cells, urine sample, stool sample, maximal voluntary contraction of quadriceps, walking test, get up-and-go test, Hand Grip test, physical activity questionnaire, bioelectrical impedance analysis and Dual Energy X-ray Absorptiometry (DEXA). |
| protein group | Experimental | Patients will be randomized in the protein group. They will have test MNA (Mini Nutritional Assessment), frailty screening tool (questionnaire FiND), clinical examination, blood sample, blood sample with heparin, white blood cells, urine sample, stool sample, maximal voluntary contraction of quadriceps, walking test, get up-and-go test, Hand Grip test, physical activity questionnaire, bioelectrical impedance analysis, Dual Energy X-ray Absorptiometry (DEXA) and protein. Receives: Dietary Supplement: Protein |
| protein and carbohydrates group | Experimental | Patients will be randomized in the protein and carbohydrates group. They will have test MNA (Mini Nutritional Assessment), frailty screening tool (questionnaire FiND), clinical examination, blood sample, blood sample with heparin, white blood cells, urine sample, stool sample, maximal voluntary contraction of quadriceps, walking test, get up-and-go test, Hand Grip test, physical activity questionnaire, bioelectrical impedance analysis, Dual Energy X-ray Absorptiometry (DEXA) and protein and carbohydrates. Receives: Dietary Supplement: Protein and Carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appendicular lean body mass (gramme)
Comparison appendicular lean body mass between the day of inclusion and 90 days after. It is measuring by Dual Energy X-ray Absorptiometry (DEXA).
Measured: Days 0 and 90
Secondary outcomes (11)
total body composition
Correlation between Dual Energy X-ray Absorptiometry (DEXA) results and bioelectrical impedance analysis results to determine total body composition.
Measured: Days 0, 45 and 90
Plasma albumin level (g/l)
blood sample.
Measured: Days 0, 45 and 90
Frailty screening tool
Determination of fragility status. 3 status : Dependent, Fragile, Robust
Measured: Days 0 and 90
Mini Nutritional Assessment score
Determine nutritional status. Score : 0-30
Measured: Days 0 and 90
Inflammatory status
Analysis of inflammatory status by blood sample results. C-reactive protein (CRP), Interleukin 6 (IL-6), Tumor necrosis factor (TNFα), monocyte chemoattractant protein 1 (MCP1)
Measured: Days 0, 45 and 90
Hand Grip test (N)
Analysis of muscle function tests.
Measured: Days 0 and 90
6 minutes walk test (m)
Analysis of muscle function tests.
Measured: Days 0 and 90
Maximal voluntary contraction of quadriceps (N)
Analysis of muscle function tests.
Measured: Days 0 and 90
Get up-and-go test (s)
Analysis of muscle function tests.
Measured: Days 0 and 90
Profiles of the differential expression of potentials biomarkers
Analysis of profiles of the differential expression of potentials biomarkers by results of blood sample with heparin, urine sample and white blood cells.
Measured: Days 0, 45 and 90
microbiota
Analysis of microbiota by stool sample results.
Measured: Days 0 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start8 Feb 2019
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Why it stopped: Stop funding by Regional Council of Auvergne-Rhône-Alpes, France
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UndernutritionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bioparhom, France, Regional Council of Auvergne-Rhône-Alpes
- Responsible party
- Sponsor
- Investigators
- Sergio POLAKOF, PhD, Study director, UMR 1019, INRA, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867006
- Sponsor's protocol ID
- 18CH036
- Other IDs
- 2018-A00712-53
- Acronym
- CARBOPTIMUS
- Status last verified
- Apr 2023
- First submitted
- 22 Oct 2018
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the Preservation of Muscle Mass and / or Its Recovery by a Protein-energy Chrononutrition Approach Dissociated From Meals
- ClinicalTrials.gov ID
- NCT03867006
- Acronym / sponsor ID
- CARBOPTIMUS / 18CH036
- Conditions
- Undernutrition
- Keywords
- Malnutrition, Undernutrition, Elderly, Protein, Carbohydrate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stop funding by Regional Council of Auvergne-Rhône-Alpes, France
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Bioparhom, France, Regional Council of Auvergne-Rhône-Alpes
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 7 Mar 2019 (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.
Muscle wasting has a multifactorial origin, including decreased physical activity, malnutrition, loss of post-incident muscle recovery abilities, and decreased ability to regenerate muscle. Among the strategies tested to improve the production of proteins and thus muscle is the supplementation of whey proteins. However this strategy does not seem sufficient and optimal to avoid muscle wasting and it must be complemented by a complementary action.
Muscle protein degradation also occurs during the nocturnal fasting periods to provide amino acids for energy purposes and to produce glucose, essential for vital organs. The preservation of the benefit of whey intake during meals could therefore be optimized by reducing the use of muscle proteins for energy purposes during the night.
Detailed description
In this study, three arms will be studied for 3 months: 1 control group, 1 group with whey supplementation at lunch, and 1 group with whey supplementation at lunch and an energy bolus before bedtime. Actions include weight and body composition monitoring, nutritional status and muscle function, as well as mechanistic.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Patients will be randomized in the control group. They will have test MNA (Mini Nutritional Assessment), frailty screening tool (questionnaire FiND), clinical examination, blood sample, blood sample with heparin, white blood cells, urine sample, stool sample, maximal voluntary contraction of quadriceps, walking test, get up-and-go test, Hand Grip test, physical activity questionnaire, bioelectrical impedance analysis and Dual Energy X-ray Absorptiometry (DEXA). |
| protein group | Experimental | Dietary Supplement: ProteinPatients will be randomized in the protein group. They will have test MNA (Mini Nutritional Assessment), frailty screening tool (questionnaire FiND), clinical examination, blood sample, blood sample with heparin, white blood cells, urine sample, stool sample, maximal voluntary contraction of quadriceps, walking test, get up-and-go test, Hand Grip test, physical activity questionnaire, bioelectrical impedance analysis, Dual Energy X-ray Absorptiometry (DEXA) and protein. |
| protein and carbohydrates group | Experimental | Dietary Supplement: Protein and CarbohydratePatients will be randomized in the protein and carbohydrates group. They will have test MNA (Mini Nutritional Assessment), frailty screening tool (questionnaire FiND), clinical examination, blood sample, blood sample with heparin, white blood cells, urine sample, stool sample, maximal voluntary contraction of quadriceps, walking test, get up-and-go test, Hand Grip test, physical activity questionnaire, bioelectrical impedance analysis, Dual Energy X-ray Absorptiometry (DEXA) and protein and carbohydrates. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Resident on the Accommodation Establishments for Dependent Elderly Persons on the Mutuality of Loire, France
- Risk of undernutrition or moderate undernutrition with one of the following criteria :
Key exclusion criteria (11 listed)
- Sub-acute pathology (flu, gastroenteritis, bacterial infections ...) or trauma (fracture, surgery ...) in the 30 days prior to inclusion.
- Hepatocellular insufficiency
- Heart failure with decompensation
- Severe dementia,
- Insulin-treated diabetes
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 |
|---|---|---|
| ProteinIn addition to their normal meal, patients will eat 30g of whey protein every lunch during 90 days. | Dietary supplement | protein group |
| Protein and CarbohydrateIn addition to their normal meal, patients will eat 30g of whey protein every lunch during 90 days and eat 60g of carbohydrates 2h after every diner during 90 days. | Dietary supplement | protein and carbohydrates group |
Primary outcome
Appendicular lean body mass (gramme)
Time frame: Days 0 and 90
Comparison appendicular lean body mass between the day of inclusion and 90 days after. It is measuring by Dual Energy X-ray Absorptiometry (DEXA).
11 secondary outcomes
total body composition
Time frame: Days 0, 45 and 90
Plasma albumin level (g/l)
Time frame: Days 0, 45 and 90
Frailty screening tool
Time frame: Days 0 and 90
Mini Nutritional Assessment score
Time frame: Days 0 and 90
Inflammatory status
Time frame: Days 0, 45 and 90
Hand Grip test (N)
Time frame: Days 0 and 90
6 minutes walk test (m)
Time frame: Days 0 and 90
Maximal voluntary contraction of quadriceps (N)
Time frame: Days 0 and 90
Get up-and-go test (s)
Time frame: Days 0 and 90
Profiles of the differential expression of potentials biomarkers
Time frame: Days 0, 45 and 90
microbiota
Time frame: Days 0 and 90
Results and safety
The study was stopped early (reason given: Stop funding by Regional Council of Auvergne-Rhône-Alpes, France). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Undernutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
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.
Sergio POLAKOF, PhD study director
UMR 1019, INRA, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein and Protein and Carbohydrate in people with Undernutrition, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
The study was stopped early (reason given: Stop funding by Regional Council of Auvergne-Rhône-Alpes, France). 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?
Appendicular lean body mass (gramme) (time frame: Days 0 and 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2023.