Identification of P-cresyl Sulfate Producer Phenotype by Oral Tyrosine Challenge Test: Interactions Among Diet, Gut Microbiota, and Host Genome

NCT04204174 | Unknown

• 1 other identifier: 08-X-108
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic kidney disease (CKD) display a substantial increase in cardiovascular disease (CVD). Moreover, the prognosis of CVD in CKD is extremely poor. Understanding the pathophysiology of CVD in CKD might help to develop treatment strategies to reduce its morbidity and mortality. Compelling evidence suggests that the uremic milieu itself plays a critical role in the development and progression of CVD in CKD. The gut microbiota is markedly altered in CKD. Fermentation of protein and amino acids by certain gut microbiota results in the generation of different uremic toxins. p-cresyl sulfate (PCS) is among the most representative gut-derived uremic toxins implicated in the pathogenesis of CVD in CKD. However, there remained no clear cut-off value of fasting plasma PCS for unfavorable clinical outcomes. Thus, we plan to establish an oral tyrosine challenge test (OTCT) integrated with dietary patterns, gut microbiome, and serum biochemistry to assess PCS synthesis capacity from host-diet-microbiota interactions.

Conditions

Chronic Kidney Diseases; Healthy

Outcome Measures

Primary Outcomes (1)

• level of serum p-cresyl sulfate

  serum p-cresyl sulfate level after oral tyrosine loading up to 48 hours

  the area under curve of serum p-cresyl sulfate

Secondary Outcomes (1)

• level of serum phenyl sulfate

  the area under curve of serum phenyl sulfate

Study Arms (1)

Tyrosine loading

EXPERIMENTAL

Dietary Supplement: Tyrosine, brand name: myprotein

Interventions

Tyrosine, brand name: myprotein DIETARY_SUPPLEMENT

tyrosine at a dose of 100 mg/kg is then administered orally to the participants once

Tyrosine loading

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic kidney disease stages 3-5D patients OR
• healthy volunteers

You may not qualify if:

• subjects who has ever exposure to antibiotics or probiotics within the 3 months before entering the study
• patients with active gastrointestinal diseases or recent gastrointestinal discomfort (such as abdominal pain or diarrhea)
• patients with liver cirrhosis
• pregnant or breastfeeding women

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (1)

Taipei Tzu Chi Hospital

New Taipei City, 231, Taiwan

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Tyrosine

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)

Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Ting-Yun Lin, MD.

  Taichung Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting-Yun Lin, MD.

CONTACT

+886-2-66289779; water_h2o_6@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrologist

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: December 18, 2019
• Study Start: December 16, 2019
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

TW (1)