The Effects of Enteral Whey Protein Supplement on Serum Albumin Level in Acute Critically Ill Neurological Patients

NCT04361357 | Unknown DMC

• 1 other identifier: zhangyan
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nutrition Disorders; Neurologic Disorder

Keywords

critically ill neurological disease; whey protein; nutrition; acute phase

Outcome Measures

Primary Outcomes (1)

• Serum albumin level

  At 14 days of enteral nutrition

Secondary Outcomes (1)

• Serum proalbumin level

  At 14 days of enteral nutrition

Other Outcomes (1)

• The number of gastrointestinal complications

  During the 14 days of enteral nutrition

Study Arms (2)

Experimental group

EXPERIMENTAL

whey protein powder was added on the basis of standardized enteral nutrition preparation.

Other: whey protein

Control group

NO INTERVENTION

standardized enteral nutrition preparation only.

Interventions

whey protein OTHER

whey protein powder was added on the basis of standardized enteral nutrition preparation.

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Nutrition Disorders; Nervous System Diseases

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Yingying Su, MD

  Xuanwu Hospital, Beijing

  STUDY DIRECTOR

Central Study Contacts

Yan Zhang, MD

CONTACT

0086-13671376710; zhangylq@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: April 24, 2020
• Study Start: January 5, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 10, 2021

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after Dec 2020, always
• Access Criteria: email to authors

Locations

CN (1)