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New treatment option for End Stage Renal Disease (ESRD)
Official title Effect of a Plant-Focused Diet on Nutritional Status in Malnourished Peritoneal Dialysis Patients
ClinicalTrials.gov ID: NCT07157397
What this study is testing
- What it's testing
- The goal of this clinical trial is to determine whether a plant-focused diet improves nutritional and health outcomes of malnourished adults undergoing peritoneal dialysis (PD). It will also learn about the safety of this diet in this population.
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult outpatients (\>18 years old), attending HTCM PD clinic visits
- Have undergone peritoneal dialysis for at least 6 months
- Have a serum albumin level \<40 g/L
- Have a BMI of \< 25 kg/m2
- Have a malnutrition inflammation score (MIS) of mild, moderate or severe
You likely can't join if
- Have been hospitalized for the past 3 months
- Have ongoing infection/sepsis
- Has undergone surgery in the past 6 months
- Have high inflammatory diseases, malignancy, or cancer
- Have dialysis adequacy of \<1.2 Kt/V
See the full eligibility criteria
- Adult outpatients (\>18 years old), attending HTCM PD clinic visits
- Have undergone peritoneal dialysis for at least 6 months
- Have a serum albumin level \<40 g/L
- Have a BMI of \< 25 kg/m2
- Have a malnutrition inflammation score (MIS) of mild, moderate or severe
- Agreed to follow the dietary instructions based on the randomization assignment
- Agreed to attend baseline visits and additional follow-up appointments at months 1, 3, and 6 post- randomization, either in person or via telehealth, and respond to monthly or more frequent phone calls
- Have been hospitalized for the past 3 months
- Have ongoing infection/sepsis
- Has undergone surgery in the past 6 months
- Have high inflammatory diseases, malignancy, or cancer
- Have dialysis adequacy of \<1.2 Kt/V
The study team makes the final eligibility decision.
Where it's taking place
- Cheras, Kuala Lumpur, Malaysia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cheras, Kuala Lumpur, Malaysia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.