Low Protein Diet, Gut Microbiome and Chronic Kidney Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

nutritional intervention with low protein diet (\< 0.8 G protein/kg body weight/day)

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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normal controls

subjects with normal renal function

Group Type NO_INTERVENTION

No interventions assigned to this group

CKD_Low protein diet

CKD patient with low protein diet (\<0.8g/kg/BW)

Group Type EXPERIMENTAL

low protein diet

Intervention Type OTHER

Low protein diet (\<0.8g/kg/BW/day)

CKD_normal protein diet

CKD patient with normal protein diet

Group Type ACTIVE_COMPARATOR

low protein diet

Intervention Type OTHER

Low protein diet (\<0.8g/kg/BW/day)

Interventions

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low protein diet

Low protein diet (\<0.8g/kg/BW/day)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. . Patients aged 30-90 years with diagnosis of CKD (defined as abovementioned).
2. . Sign the inform consent and agree to participate in this study.
3. . 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

Exclusion Criteria

1. . 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.
2. . History of or infection disease requiring admission in the past 3 months or, concomitant antibiotics use.
3. . Concomitant use of probiotics or prebiotics.
4. . Pregnancy.
5. . Renal transplant recipients.

Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes