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A study on the clinical efficacy and mechanism of action of albumin peptides in improving hypoproteinemia

A study on the clinical efficacy and mechanism of action of albumin peptides in improving hypoproteinemia

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066221
Enrollment
Unknown
Registered
2022-11-28
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoproteinemia

Interventions

Experimental group:Whey Protein Isolated Solid Beverages (containing 18g protein/bag, 20g/bag),take orally for 21 days
Control group:Whey Protein Isolated Solid Beverages (containing 18g protein/bag, 20g/bag),take orally for 21 days
Positive Control group:Protein Hydrolysate Oral solution Solution (containing 14.7g protein/bottle, 100mL/bottle),take orally for 25 days

Sponsors

Department of Pharmacy, Jincheng General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients aged from 20 to 75 years (including borderline values), male or female; (2) Plasma total protein = 60 g/L or plasma albumin 28-35 g/L; (3) Hemoglobin (Hb) > 90 g/L; (4) BMI > 16 kg/m2; (5) Patients has no subjective weight loss >10 % in the recent 6 months; (6) Patients has no cognitive impairment and positive cooperation in completing the observation; (7) Patients or their guardians voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Liver and kidney function test results showed ALT, AST > 2 times the upper limit of normal values, or Cr > 1.5 times the upper limit of normal values (refer to the normal range of laboratory tests);(2) Those who are allergic to animal protein (egg protein); (3) Patients with chronic anemia, Hb <60g/L; patients with concurrent metabolic diseases; (4) Patients with clear contraindications to enteral nutrition; suspected or confirmed history of substance abuse; (5)Patients with comorbid other psychiatric disorders and poor compliance. (6) Patients have large amounts of exudative pleural/ ascites, or large amounts of urinary protein due to abnormal renal function . (7) Patients who are at risk of drug combination or adverse reactions between the drugs used and the clinical drug hydrolyzed protein oral solution. (8) Patients who have participated in this clinical trial within the last two months. (9) Patients deemed unsuitable for clinical trials by the investigator.

Design outcomes

Primary

MeasureTime frame
Blood biochemical indicators;

Secondary

MeasureTime frame
Routine blood indicators;Serological indicators;Phenotypic observation;

Countries

China

Contacts

Public ContactZhang Lu?Ji Ligang

China National Research Institute of Food and Fermentation Industries;Jincheng General Hospital;rict, Beijing,China

zhanglu8078@126.com+86 15210608078

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026