Diffenence of Protein Diets on Hemodialysis PatientsNCT04077918
Comparison of the Effects of Different Protein Diet in Hemodialysis Patients
A study testing protein diet in people with Diffenence of Protein Diets on Hemodialysis Patients, run by Camillians Saint Mary's Hospital Luodong.
Trial summary
Chronic hemodialysis (CHD) patients are vulnerable to develop protein energy malnutrition and make a notion that to maintain the nutritional status is of paramount importance in these patients. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Diffenence of Protein Diets on Hemodialysis Patients
- What is being tested?
- protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hemodialysis patient
Who cannot join
- Hemodialysis less than 3 months
- Age < 20 years or >90 years
- Serum albumin < 3 g/dL，
- Daily protein diet < 0.6 gm/kg/day or > 1.2 gm/kg/ day，
- Cannot obey the diet plan: Gastrectomy, difficult in swallowing
- Active infection, severe illness: cancer patient, liver cirrhosis, etc.
- Unable to cooperate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of the Effects of Animal Protein Diet and Plant Protein Diet on Blood Test Result and Clinical Outcome in Hemodialysis Patients
Chronic hemodialysis (CHD) patients are vulnerable to develop protein energy malnutrition and make a notion that to maintain the nutritional status is of paramount importance in these patients. However, proteins intake from vegetarian and meat diet were observed to have different impacts on nutritional and inflammatory status, mineral homeostasis and its related hormones, and clinical outcomes in non-dialysis CKD patients. In here, we aim to investigate these impacts in CHD patients.
- Being tested
- protein diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein dietDietary supplement
100 CHD patients will be recruited and randomized into 2 groups with an additional animal or plant protein 18g per day
| Study group | Role | What they receive |
|---|---|---|
| Plant protein diet | Active comparator | 18 g of plant protein diet added every day for 3 months , and after washout for 1 month, 18 g of animal protein diet added every day for 3 months Receives: Dietary Supplement: protein diet |
| Animal protein diet | Active comparator | 18 g of animal protein diet added every day for 3 months, and after washout for 1 month, 18 g of plant protein diet added every day for 3 months Receives: Dietary Supplement: protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistical difference of serum biomarkers ( P value)
The items scheduled to be evaluated in this study include serum albumin, pre-albumin, phosphate, calcium, magnesium, lipid profile, ferritin, transferrin, hs-CRP, Alk-P, iPTH, 25(OH)D3, intact \& C-terminal FGF23, Klotho and hepcidin levels. We'll collect the patient's serum data in plant diet group, and collect the serum data in animal diet group, then we'll compare the data in these two groups to see whether there is any difference between each item.
Measured: 7 months
Secondary outcomes (1)
Statistical difference of medical visits
We'll review the patient's medical record in outpatient department . We'll look at what's the diagnosis and what's the number of the medical visits during the study period.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffenence of Protein Diets on Hemodialysis PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Camillians Saint Mary's Hospital Luodong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shih-Ching Tsai, MD, Principal investigator, St. Mary's Hospital Luodong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077918
- Sponsor's protocol ID
- SMHprotdiet
- Status last verified
- Sep 2019
- First submitted
- 24 Aug 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Animal Protein Diet and Plant Protein Diet on Blood Test Result and Clinical Outcome in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT04077918
- Acronym / sponsor ID
- SMHprotdiet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Camillians Saint Mary's Hospital LuodongUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic hemodialysis (CHD) patients are vulnerable to develop protein energy malnutrition and make a notion that to maintain the nutritional status is of paramount importance in these patients. However, proteins intake from vegetarian and meat diet were observed to have different impacts on nutritional and inflammatory status, mineral homeostasis and its related hormones, and clinical outcomes in non-dialysis CKD patients. In here, we aim to investigate these impacts in CHD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant protein diet | Active comparator | Dietary Supplement: protein diet18 g of plant protein diet added every day for 3 months , and after washout for 1 month, 18 g of animal protein diet added every day for 3 months |
| Animal protein diet | Active comparator | Dietary Supplement: protein diet18 g of animal protein diet added every day for 3 months, and after washout for 1 month, 18 g of plant protein diet added every day for 3 months |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic hemodialysis patient
Key exclusion criteria (7 listed)
- Hemodialysis less than 3 months
- Age < 20 years or >90 years
- Serum albumin < 3 g/dL，
- Daily protein diet < 0.6 gm/kg/day or > 1.2 gm/kg/ day，
- Cannot obey the diet plan: Gastrectomy, difficult in swallowing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protein diet100 CHD patients will be recruited and randomized into 2 groups with an additional animal or plant protein 18g per day | Dietary supplement | Animal protein diet, Plant protein diet |
Primary outcome
Statistical difference of serum biomarkers ( P value)
Time frame: 7 months
The items scheduled to be evaluated in this study include serum albumin, pre-albumin, phosphate, calcium, magnesium, lipid profile, ferritin, transferrin, hs-CRP, Alk-P, iPTH, 25(OH)D3, intact \& C-terminal FGF23, Klotho and hepcidin levels. We'll collect the patient's serum data in plant diet group, and collect the serum data in animal diet group, then we'll compare the data in these two groups to see whether there is any difference between each item.
1 secondary outcome
Statistical difference of medical visits
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shih-Ching Tsai, MD principal investigator
St. Mary's Hospital Luodong
Questions about this trial
What is this clinical trial studying?
A study testing protein diet in people with Diffenence of Protein Diets on Hemodialysis Patients, run by Camillians Saint Mary's Hospital Luodong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shih-Ching Tsai, MD (+88639544106 ext. 7951, uftsai.tseng@msa.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistical difference of serum biomarkers ( P value) (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.