NCT07060040Not yet recruiting
The Effects of a Dialysis-Specific Formula Rich in Branched-Chain Amino Acids, Omega-3, and Dietary Fiber on Nutritional Status
Source: ClinicalTrials.gov · Last updated 11 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The aim of this study is to evaluate the effects of a specialized oral nutritional supplement (SF) enriched with BCAAs, omega-3 fatty acids, and dietary fiber on improving the nutritional status of dialysis patients with mild to moderate malnutrition, and thereby alleviating fatigue and enhancing quality of life. We will assess various aspects of protein-energy wasting (PEW), as well as changes in the Malnutrition Inflammation Score (MIS), Geriatric Nutritional Risk Index (GNRI), fatigue, appetite, serum BCAA levels, uremic toxins, and gut microbiota composition.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 20 Jun 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT07060040
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Jul 2025 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with severe illnesses (including burn injuries), undergoing major surgery, with abnormal liver function (GOT and GPT levels more than 5 times the upper limit of normal), or with malignancy (6) Participation in another clinical trial of investigational drugs or concurrent use of investigational drugs within 30 days prior to or during this trial (7) Any other serious medical condition as determined by the investigator that would make the patient unsuitable for participation
Other illness
- Known allergy or intolerance to any component of the product, or deemed by a physician to be unable to complete the trial
Lab values
- Serum albumin (Alb) \< 3.0 g/dL
Other
- Patients who refuse to sign the informed consent form or are unable to follow study instructions
- Pregnant or breastfeeding women
Who the study is looking for
- Patients with ESRD who have been receiving dialysis for more than three months
- Serum albumin (Alb) ≤ 4.0 g/dL, or body mass index (BMI) ≤ 20, or normalized protein catabolic rate (nPCR) ≤ 0.8
- Male or female patients aged 20 years or older
Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.