Nutrition DisordersNCT04361357
The Effects of Enteral Whey Protein Supplement on Serum Albumin Level in Acute Critically Ill Neurological Patients
A study testing whey protein in people with Nutrition Disorders and Neurologic Disorder, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The incidence of malnutrition in patients with severe neurological diseases is approximately 37%, among which hypoproteinemia is a common manifestation. It has been confirmed that serum albumin level is closely related to severity and mortality for patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nutrition Disorders, Neurologic Disorder
- What is being tested?
- whey protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2020to 31 Dec 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of severe neurological Disease
- Serum albumin ≥30g/L
- Weight: 50~90kg
- Nutrition risk screening 2002 (NRS2002) ≥3 points
- Acute gastrointestinal function injury (acute gastrointestinal injury, AGI) class 1~2
- Expected enteral nutrition in tube feeding for at least 14 days
- Obtain the informed consent of the patient or its authorized client
Who cannot join
- Pregnant and breast-feeding women
- Serious heart, lung and other important organ function injury
- Malignant tumor
- Hypothermia treatment
- BMI≥28
- Allergic to milk
- Receiving parenteral nutritional support therapy
- APACHE II ≥30
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital
Beijing
Yan Zhang, MD, 0086-13671376710, zhangylq@sina.com
Yan Zhang, MD
About this study
The incidence of malnutrition in patients with severe neurological diseases is approximately 37%, among which hypoproteinemia is a common manifestation. It has been confirmed that serum albumin level is closely related to severity and mortality for patients. Protein is the basic component of tissue cells in the body, which plays an important role in the growth and development of senescent cells and the repair of damaged tissues. At present, the results of some randomized controlled studies show that it is difficult to achieve enough protein supplementation by commercial standard enteral nutrition agents alone, and additional protein supplementation is required. Commercial standard enteral nutrition preparations, whose whole protein components are casein and soy protein, do not achieve optimal uptake and utilization compared to whey proteins, which are more readily absorbed and utilized by the human gut. Whey protein and its hydrolyzed products have better nutritional quality than casein, which can provide high-quality nitrogen source for enteral nutrition and play an important role in correcting negative nitrogen balance, promoting wound healing and improving body immunity. Whether whey protein supplementation based on standard enteral nutrition preparation can improve serum albumin level and reduce the incidence of hypoproteinemia in patients with severe acute neurological disease has not been proved. In conclusion, we propose the hypothesis that compared with the standard enteral nutrition preparation regimen, the enteral nutrition regimen supplemented with whey protein in patients with severe neurological disease is more beneficial to improve the nutritional indicators of patients and reduce the occurrence of hypoproteinemia. It is expected that this randomized controlled trial will provide a new clinical basis for optimizing the enteral nutrition support program for patients with severe neurological diseases.
Read the detailed description
The purpose of the study is to compare standard enteral nutrition regimen with the enteral nutrition regimen supplemented with whey protein in severe neurological disease patients and to observe nutritional indicators improvement in these patients. A total of 116 subjects will be included. Counting process is as follows: referring available literature and the mean value of serum albumin in patients on the 14th day of our preliminary tests, and the difference test is used to compare the mean values of two independent samples. The ratio of the experimental group and control group is 1:1. It was assumed that the serum albumin level in the experimental group was higher than that in the control group. A single end is taken, α=0.05, 1-β=0.80, experimental group patients serum albumin（Χ±S）=37.9±5.1, the control group serum albumin（Χ±S）=35.6±4.8, so the total sample size was 116.It was estimated that 116 patients were enrolled consecutively, which were divided into experimental group and control group by computer generated random number table. Patients in both groups received enteral nutrition therapy with continuous tube feeding for 14 days. According to the nutritional treatment requirements of critically ill patients in the Asia-Pacific region in 2016, patients with severe acute stress were given energy demand for 25~30kcal/kg/d, protein demand for 1.2~2g/kg/d and other standardized clinical treatments. Control group nutrition program: standardized enteral nutrition preparation only. Experimental group nutrition program: whey protein powder was added on the basis of standardized enteral nutrition preparation. According to the body weight of the patients, different enteral nutritional preparations and dose adjustments were selected to ensure that the calorie and protein intake of the two groups of patients met the above nutritional treatment requirements.Primary endpoint: serum albumin level at 14 days of enteral nutrition. Secondary end points: 1. APACHE II, GCS and other clinical scores at 14 days; 2. total serum protein, proalbumin, hemoglobin and other nutritional indicators; 3. the number and ratio of white blood cells, neutrophils, c-reactive protein, interleukin-6, procalcitonin, absolute count of T lymphocyte subsets, immunoglobulin and other inflammatory indicators at 14 days; 4. the number of cases of gastrointestinal complications such as gastric retention, vomiting, diarrhea, abdominal distention, constipation and gastrointestinal bleeding during the 14 days of enteral nutrition; 5. the number of patients with serum albumin < 30g/L within 14 days after admission.
- Conditions
- Nutrition Disorders, Neurologic Disorder
- Being tested
- whey protein
- Keywords
- critically ill neurological disease, whey protein, nutrition, acute phase
- Medical subject headings
- Nutrition Disorders, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whey proteinOther
whey protein powder was added on the basis of standardized enteral nutrition preparation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | whey protein powder was added on the basis of standardized enteral nutrition preparation. Receives: Other: whey protein |
| Control group | No intervention | standardized enteral nutrition preparation only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum albumin level
Measured: At 14 days of enteral nutrition
Secondary outcomes (1)
Serum proalbumin level
Measured: At 14 days of enteral nutrition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start5 Jan 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition DisordersStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingying Su, MD, Study director, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361357
- Sponsor's protocol ID
- zhangyan
- Status last verified
- Feb 2020
- First submitted
- 5 Mar 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Enteral Whey Protein Supplement on Serum Albumin Level in Acute Critically Ill Neurological Patients
- ClinicalTrials.gov ID
- NCT04361357
- Acronym / sponsor ID
- zhangyan
- Conditions
- Nutrition Disorders, Neurologic Disorder
- Keywords
- critically ill neurological disease, whey protein, nutrition, acute phase
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Apr 2020 (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.
The incidence of malnutrition in patients with severe neurological diseases is approximately 37%, among which hypoproteinemia is a common manifestation. It has been confirmed that serum albumin level is closely related to severity and mortality for patients. Protein is the basic component of tissue cells in the body, which plays an important role in the growth and development of senescent cells and the repair of damaged tissues. At present, the results of some randomized controlled studies show that it is difficult to achieve enough protein supplementation by commercial standard enteral nutrition agents alone, and additional protein supplementation is required. Commercial standard enteral nutrition preparations, whose whole protein components are casein and soy protein, do not achieve optimal uptake and utilization compared to whey proteins, which are more readily absorbed and utilized by the human gut. Whey protein and its hydrolyzed products have better nutritional quality than casein, which can provide high-quality nitrogen source for enteral nutrition and play an important role in correcting negative nitrogen balance, promoting wound healing and improving body immunity. Whether whey protein supplementation based on standard enteral nutrition preparation can improve serum albumin level and reduce the incidence of hypoproteinemia in patients with severe acute neurological disease has not been proved. In conclusion, we propose the hypothesis that compared with the standard enteral nutrition preparation regimen, the enteral nutrition regimen supplemented with whey protein in patients with severe neurological disease is more beneficial to improve the nutritional indicators of patients and reduce the occurrence of hypoproteinemia. It is expected that this randomized controlled trial will provide a new clinical basis for optimizing the enteral nutrition support program for patients with severe neurological diseases.
Detailed description
The purpose of the study is to compare standard enteral nutrition regimen with the enteral nutrition regimen supplemented with whey protein in severe neurological disease patients and to observe nutritional indicators improvement in these patients. A total of 116 subjects will be included. Counting process is as follows: referring available literature and the mean value of serum albumin in patients on the 14th day of our preliminary tests, and the difference test is used to compare the mean values of two independent samples. The ratio of the experimental group and control group is 1:1. It was assumed that the serum albumin level in the experimental group was higher than that in the control group. A single end is taken, α=0.05, 1-β=0.80, experimental group patients serum albumin（Χ±S）=37.9±5.1, the control group serum albumin（Χ±S）=35.6±4.8, so the total sample size was 116.It was estimated that 116 patients were enrolled consecutively, which were divided into experimental group and control group by computer generated random number table. Patients in both groups received enteral nutrition therapy with continuous tube feeding for 14 days. According to the nutritional treatment requirements of critically ill patients in the Asia-Pacific region in 2016, patients with severe acute stress were given energy demand for 25~30kcal/kg/d, protein demand for 1.2~2g/kg/d and other standardized clinical treatments. Control group nutrition program: standardized enteral nutrition preparation only. Experimental group nutrition program: whey protein powder was added on the basis of standardized enteral nutrition preparation. According to the body weight of the patients, different enteral nutritional preparations and dose adjustments were selected to ensure that the calorie and protein intake of the two groups of patients met the above nutritional treatment requirements.Primary endpoint: serum albumin level at 14 days of enteral nutrition. Secondary end points: 1. APACHE II, GCS and other clinical scores at 14 days; 2. total serum protein, proalbumin, hemoglobin and other nutritional indicators; 3. the number and ratio of white blood cells, neutrophils, c-reactive protein, interleukin-6, procalcitonin, absolute count of T lymphocyte subsets, immunoglobulin and other inflammatory indicators at 14 days; 4. the number of cases of gastrointestinal complications such as gastric retention, vomiting, diarrhea, abdominal distention, constipation and gastrointestinal bleeding during the 14 days of enteral nutrition; 5. the number of patients with serum albumin < 30g/L within 14 days after admission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: whey proteinwhey protein powder was added on the basis of standardized enteral nutrition preparation. |
| Control group | No intervention | –standardized enteral nutrition preparation only. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of severe neurological Disease
- Serum albumin ≥30g/L
- Weight: 50~90kg
- Nutrition risk screening 2002 (NRS2002) ≥3 points
- Acute gastrointestinal function injury (acute gastrointestinal injury, AGI) class 1~2
Key exclusion criteria (8 listed)
- Pregnant and breast-feeding women
- Serious heart, lung and other important organ function injury
- Malignant tumor
- Hypothermia treatment
- BMI≥28
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 |
|---|---|---|
| whey proteinwhey protein powder was added on the basis of standardized enteral nutrition preparation. | Other | Experimental group |
Primary outcome
Serum albumin level
Time frame: At 14 days of enteral nutrition
1 secondary outcome
Serum proalbumin level
Time frame: At 14 days of enteral nutrition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: Yes. study protocol can be shared.
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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.
Yingying Su, MD study director
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whey protein in people with Nutrition Disorders and Neurologic Disorder, run by Xuanwu Hospital, Beijing at 1 site in China.
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 8 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 10 Feb 2021. 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 China. 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 Yan Zhang, MD (0086-13671376710, zhangylq@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum albumin level (time frame: At 14 days of enteral nutrition). 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 10 Feb 2021.