Study to evaluate the efficacy and safety of salmon protein hydrolyate in whey protein isolate powder to improve hemoglobin and serum ferritin in anaemic patients

A prospective, open, randomized study to evaluate the efficacy and safety of 20% HBC salmon protein hydrolyate in whey protein isolate (Whey Tech Pro Gold â?¢) powder to improve hemoglobin and serum ferritin in anaemic patients - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/02/004433

Enrollment

Registered

2014-02-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Anemia

Interventions

Intervention1: Whey Tech Pro Gold (TM)) Powder: Powder is 20% w/w Hofseth Biocareâ??s Salmon Protein Hydrolysate plus 80% w/w Whey Protein Isolate. Powder will be provided to patients in 1kg bottles e

Eligibility

Inclusion criteria

Inclusion criteria: 1. Understand and voluntarily sign an informed consent form. 2. Able to adhere to the study visit schedule and other protocol requirements. 3. Women and Men with Hemoglobin concentration >= 8 g/dL and 4. Situational anemia.

Exclusion criteria

Exclusion criteria: 1. Red blood cell transfusions within the past 3 months. 2. Estimated glomerular filtration rate (eGFR) of MDRD). 3. Use of erythropoiesis stimulating agents (ESA) in the past 3 months. 4. Active infection defined as symptomatic, requiring active treatment (prophylaxis allowed) or hospitalized for > 24 hours primarily for infection within the past month. 5. Uncontrolled hypertension defined as diastolic blood pressure > 100 mm Hg or systolic blood pressure > 160 mm Hg on 2 separate occasions during screening Period. 6. Other primary uncorrected cause for anemia including: a. Known active inflammatory disease including autoimmune diseases (e.g., systemic lupus erythematosis, rheumatoid arthritis, mixed connective tissue disease, sarcoidosis, bronchiolitis obliterans, vasculitis, polymyalgia rheumatica, temporal artheritis). b. Chronic active infection (e.g., HIV, viral hepatitis). c. Acute infection within past 3 months (pneumonia, sepsis, bacteremia, prostatitis). d. Receipt of immunosuppressive therapy in the past 2 years. e. Any cancer (aside from nonmelanoma skin cancer) in the past 2 years or on therapy for cancer. 7. Elevated AST or ALT >= 2x upper limit of normal. 8. Total bilirubin > 1.5 mg/dL. 9. Use of any other experimental drug or therapy within 28 days of initial screening visit. 10. Dementia defined as the inability to independently provide informed consent. 11. Recent history of Gastroin test bleed.

Design outcomes

Primary

Measure	Time frame
To determine the effect of Whey Tech Pro Gold (TM) to increase hemoglobin in anemic patientsTimepoint: At baseline (Day 1), Day 30 and Day 50	—

Secondary

Measure	Time frame
To determine the efficacy of Whey Tech Pro Gold (TM) on following parameters: Serum ferritin and bile acid levels. Quality of life. Verify the health safety of Whey Tech Pro Gold (TM) using a standard physical system.Timepoint: At baseline (Day 1), Day 30 and Day 50	—

Countries

India

Contacts

Public ContactMr Bharani Bhskar

Spectrum Clinical Research Pvt. Ltd.

bbhaskar@spectrumcr.com02240645100

Outcome results

None listed

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