Chronic Kidney DiseasesNCT05019599
Low Protein Diet, Gut Microbiome and Chronic Kidney Disease
A study testing low protein diet in people with Chronic Kidney Diseases, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Chronic kidney disease (CKD) is a worldwide public health dilemma because of close association with multiple comorbidities, demanding high cardiovascular events, mortality and expensive medical cost. Novel and effective therapeutic measures remain urgently needed to reduce burden and impact of disease. Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- low protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2019to 31 Oct 2021
- 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 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- . Patients aged 30-90 years with diagnosis of CKD (defined as abovementioned).
- . Sign the inform consent and agree to participate in this study.
- . Compliant to low protein diet (defined as protein intake <0.8 g/Kg/day) for 4 weeks assessed by 24h urine urea estimates, before enrollment
Who cannot join
- . History of any malignancy, liver cirrhosis, intestinal operation, irritable bowel syndrome, cardiovascular disease (defined as myocardial infarction, documented Q wave on EKG, unstable angina, coronary artery disease with stenosis > 75%, congestive heart failure with Ejection Fraction < 50% and cerebrovascular disease) in the past 3 months.
- . History of or infection disease requiring admission in the past 3 months or, concomitant antibiotics use.
- . Concomitant use of probiotics or prebiotics.
- . Pregnancy.
- . Renal transplant recipients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Role of Low Protein Diet on the Gut Microbiome, Related Metabolites and Renal Function in Chronic Kidney Disease
Chronic kidney disease (CKD) is a worldwide public health dilemma because of close association with multiple comorbidities, demanding high cardiovascular events, mortality and expensive medical cost. Novel and effective therapeutic measures remain urgently needed to reduce burden and impact of disease. Advanced renal failure can profoundly alter the biochemical milieu of the gastrointestinal tract leading to a leak gut. Application of 16s rRNA gene analysis identified an increase of Clostridia, Actinobacteria, and Gammaproteobacteria in hemodialysis patients and decrease of Bifidobacterium and lactobacillus in peritoneal patients. This altered microbiome consequently affect production of indole or phenol derived uremic toxins leading to renal damage. Our preliminary results indicated reduced number and diversity of intestinal microbes CKD patients compared to normal. Different dietary nutrients can affect the gut microbiome and derive several deleterious metabolites leading to metabolic disarrangement. Clinically, low-protein diet should be prescribe to renal patients to preserve renal function and high fat content are usually recommended to avoid caloric malnutrition to dietary restriction. The changes of diet-microbiome-metabolite interaction are large unknown with this dietary manipulation. The aims of this study is to determine the renal progression-associated gene and taxonomic alterations bymetagenome-wide association studies and the functional characterization of gut microbiome in CKD patients receiving different low-protein or high-fat diets. The results of the study will provide insight on the exact role of dietary manipulation in CKD patients from gut-renal cross talk.
- Conditions
- Chronic Kidney Diseases
- Being tested
- low protein diet
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low protein dietOther
Low protein diet (<0.8g/kg/BW/day)
| Study group | Role | What they receive |
|---|---|---|
| normal controls | No intervention | subjects with normal renal function |
| CKD_Low protein diet | Experimental | CKD patient with low protein diet (<0.8g/kg/BW) Receives: Other: low protein diet |
| CKD_normal protein diet | Active comparator | CKD patient with normal protein diet Receives: Other: low protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of gut microbiota
change of relative abundance of microbes
Measured: 3 months
change of host metabolite concentration
change of concentration of serum metabolomic profile
Measured: 3 months
change of renal function
serum creatinine, estimated glomerular filtration rate or urine total protein
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Aug 2019
- Primary completion31 Jul 2020
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- nutritional intervention with low protein diet (\< 0.8 G protein/kg body weight/day)
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- I Wen Wu, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019599
- Sponsor's protocol ID
- IWW-0008
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu IW, Lee CC, Hsu HJ, Sun CY, Chen YC, Yang KJ, Yang CW, Chung WH, Lai HC, Chang LC, Su SC. Compositional and Functional Adaptations of Intestinal Microbiota and Related Metabolites in CKD Patients Receiving Dietary Protein Restriction. Nutrients. 2020 Sep 12;12(9):2799. doi: 10.3390/nu12092799.
PubMed 32932711
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Role of Low Protein Diet on the Gut Microbiome, Related Metabolites and Renal Function in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05019599
- Acronym / sponsor ID
- IWW-0008
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 25 Aug 2021 (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 kidney disease (CKD) is a worldwide public health dilemma because of close association with multiple comorbidities, demanding high cardiovascular events, mortality and expensive medical cost. Novel and effective therapeutic measures remain urgently needed to reduce burden and impact of disease. Advanced renal failure can profoundly alter the biochemical milieu of the gastrointestinal tract leading to a leak gut. Application of 16s rRNA gene analysis identified an increase of Clostridia, Actinobacteria, and Gammaproteobacteria in hemodialysis patients and decrease of Bifidobacterium and lactobacillus in peritoneal patients. This altered microbiome consequently affect production of indole or phenol derived uremic toxins leading to renal damage. Our preliminary results indicated reduced number and diversity of intestinal microbes CKD patients compared to normal. Different dietary nutrients can affect the gut microbiome and derive several deleterious metabolites leading to metabolic disarrangement. Clinically, low-protein diet should be prescribe to renal patients to preserve renal function and high fat content are usually recommended to avoid caloric malnutrition to dietary restriction. The changes of diet-microbiome-metabolite interaction are large unknown with this dietary manipulation. The aims of this study is to determine the renal progression-associated gene and taxonomic alterations bymetagenome-wide association studies and the functional characterization of gut microbiome in CKD patients receiving different low-protein or high-fat diets. The results of the study will provide insight on the exact role of dietary manipulation in CKD patients from gut-renal cross talk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- nutritional intervention with low protein diet (< 0.8 G protein/kg body weight/day)
| Arm | Type | Receives |
|---|---|---|
| normal controls | No intervention | –subjects with normal renal function |
| CKD_Low protein diet | Experimental | Other: low protein dietCKD patient with low protein diet (<0.8g/kg/BW) |
| CKD_normal protein diet | Active comparator | Other: low protein dietCKD patient with normal protein diet |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- . Patients aged 30-90 years with diagnosis of CKD (defined as abovementioned).
- . Sign the inform consent and agree to participate in this study.
- . Compliant to low protein diet (defined as protein intake <0.8 g/Kg/day) for 4 weeks assessed by 24h urine urea estimates, before enrollment
Key exclusion criteria (5 listed)
- . History of any malignancy, liver cirrhosis, intestinal operation, irritable bowel syndrome, cardiovascular disease (defined as myocardial infarction, documented Q wave on EKG, unstable angina, coronary artery disease with stenosis > 75%, congestive heart failure with Ejection Fraction < 50% and cerebrovascular disease) in the past 3 months.
- . History of or infection disease requiring admission in the past 3 months or, concomitant antibiotics use.
- . Concomitant use of probiotics or prebiotics.
- . Pregnancy.
- . Renal transplant recipients.
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 |
|---|---|---|
| low protein dietLow protein diet (<0.8g/kg/BW/day) | Other | CKD_Low protein diet, CKD_normal protein diet |
Primary outcome
change of gut microbiota
Time frame: 3 months
change of relative abundance of microbes
change of host metabolite concentration
Time frame: 3 months
change of concentration of serum metabolomic profile
change of renal function
Time frame: 3 months
serum creatinine, estimated glomerular filtration rate or urine total protein
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Results publication: PubMed 32932711Wu IW, Lee CC, Hsu HJ, Sun CY, Chen YC, Yang KJ, Yang CW, Chung WH, Lai HC, Chang LC, Su SC. Compositional and Functional Adaptations of Intestinal Microbiota and Related Metabolites in CKD Patients Receiving Dietary Protein Restriction. Nutrients. 2020 Sep 12;12(9):2799. doi: 10.3390/nu12092799.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
I Wen Wu principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low protein diet in people with Chronic Kidney Diseases, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 5 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 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of gut microbiota (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05019599, which also lists 1 linked publication.
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 25 Aug 2021.