Low Protein Diet, Gut Microbiome and Chronic Kidney Disease

NCT05019599 | Unknown

• 1 other identifier: IWW-0008
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• change of gut microbiota

  change of relative abundance of microbes

  3 months

• change of host metabolite concentration

  change of concentration of serum metabolomic profile

  3 months

• change of renal function

  serum creatinine, estimated glomerular filtration rate or urine total protein

  3 months

Study Arms (3)

normal controls

NO INTERVENTION

subjects with normal renal function

CKD_Low protein diet

EXPERIMENTAL

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

Other: low protein diet

CKD_normal protein diet

ACTIVE COMPARATOR

CKD patient with normal protein diet

Other: low protein diet

Interventions

low protein diet OTHER

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

CKD_Low protein diet; CKD_normal protein diet

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Keelung, 204, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 32932711 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• I Wen Wu

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: August 25, 2021
• Study Start: August 1, 2019
• Primary Completion: July 31, 2020
• Study Completion: October 31, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)