The Effects of a Dialysis-Specific Formula Rich in Branched-Chain Amino Acids, Omega-3, and Dieta… (NCT07060040) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effects of a Dialysis-Specific Formula Rich in Branched-Chain Amino Acids, Omega-3, and Dietary Fiber on Nutritional Status
100 participantsStarted 2025-07
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Serum albumin (Alb) \< 3.0 g/dL
* Known allergy or intolerance to any component of the product, or deemed by a physician to be unable to complete the trial
* Patients who refuse to sign the informed consent form or are unable to follow study instructions
* Pregnant or breastfeeding women
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Malnutrition Inflammation Score (MIS)
Timeframe: From enrollment to the end of treatment at 12 weeks
2
Change in Geriatric Nutritional Risk Index (GNRI)
Timeframe: From enrollment to the end of treatment at 12 weeks
3
Change in serum albumin concentration
Timeframe: From enrollment to end of treatment (12 weeks)
4
Change in serum pre-albumin concentration
Timeframe: From enrollment to end of treatment (12 weeks)
5
Change in Protein-Energy Wasting (PEW) status
Timeframe: From enrollment to end of treatment (12 weeks)
6
Change in body composition
Timeframe: From enrollment to end of treatment (12 weeks)