Gut Flora Dependent Metabolism of Dietary Phosphatidylcholine and Cardiovascular Disease (Glory)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01519310
First received: January 23, 2012
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to see if intestinal bacteria plays a role in choline metabolism (a form of choline monitored in this study is called phosphatidylcholine, also known as lecithin). This study will help to determine if choline metabolism is affected by short-term antibiotic therapy, and/or can be altered by probiotic therapy (e.g. in the form of eating yogurt).


Condition Intervention Phase
Nutrition
Other: Antibiotic (metronidazole and ciprofloxacin)/probiotic
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Gut Flora Dependent Metabolism of Dietary Phosphatidylcholine and Cardiovascular Disease

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Primary Outcome [ Designated as safety issue: No ]
    Phosphatidylcholine derived gut flora metabolites


Secondary Outcome Measures:
  • Secondary Outcome Measures [ Designated as safety issue: No ]
    Cardiometabolic risk markers


Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Group 1 (Antibiotics/probioitic):
Other: Antibiotic (metronidazole and ciprofloxacin)/probiotic

Antibiotic cocktail/yogurt as follows:

Group 1: antibiotics for 1 week, followed by probiotics for 3 weeks; Group 2: antibiotics for 1 week, followed by no probiotics for 3 weeks. Group 3: no antibiotics for 1 week, followed by probiotics for 3 weeks.

Active Comparator: Group 2
Group 2 (Antibiotics/no-probiotic):
Other: Antibiotic (metronidazole and ciprofloxacin)/probiotic

Antibiotic cocktail/yogurt as follows:

Group 1: antibiotics for 1 week, followed by probiotics for 3 weeks; Group 2: antibiotics for 1 week, followed by no probiotics for 3 weeks. Group 3: no antibiotics for 1 week, followed by probiotics for 3 weeks.

Active Comparator: Group 3
Group 3 (no-Antibiotics/probiotic):
Other: Antibiotic (metronidazole and ciprofloxacin)/probiotic

Antibiotic cocktail/yogurt as follows:

Group 1: antibiotics for 1 week, followed by probiotics for 3 weeks; Group 2: antibiotics for 1 week, followed by no probiotics for 3 weeks. Group 3: no antibiotics for 1 week, followed by probiotics for 3 weeks.


Detailed Description:

The purpose of this study is to see if intestinal bacteria plays a role in choline metabolism (a form of choline monitored in this study is called phosphatidylcholine, also known as lecithin). This study will help to determine if choline metabolism is affected by short-term antibiotic therapy, and/or can be altered by probiotic therapy (e.g. in the form of eating yogurt).

Metabolism is a process that turns foods we eat into fuel for our bodies. Choline is nutrient found in a type of fat commonly found in foods. There is evidence that choline metabolism by bacteria in the intestines may be linked to cardiac risk.

The purpose of this study is to see if intestinal bacteria plays a role in choline metabolism (a form of choline monitored in this study is called phosphatidylcholine, also known as lecithin). This study will help to determine if choline metabolism is affected by short-term antibiotic therapy, and/or can be altered by probiotic therapy (e.g. in the form of eating yogurt).

This single center study will randomize 30 normal, healthy volunteers to 1 of 3 groups:

Group 1: antibiotics for 1 week, followed by probiotics for 3 weeks; Group 2: antibiotics for 1 week, followed by no probiotics for 3 weeks. Group 3: no antibiotics for 1 week, followed by probiotics for 3 weeks.

The antibiotics to be used will be metronidazole (500 mg twice daily) and ciprofloxacin (500 mg daily) for one week. The probiotics to be used will be one serving size of standard flavored yogurt (approximately 170 g) twice daily for up to three weeks.

Study visits will occur at baseline, 1 week, and 4 weeks. Blood and urine samples will be collected at the start of each visit. Subjects will then eat 2 hard boiled eggs and be given a standard medical isotope. Additional blood samples will be obtained at 1, 2, 3, 4, and 6 hours, and a urine sample will be collected at 6 hours. Samples will be analyzed for choline levels, its byproducts, and isotope levels.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women age 18 years or above.
  • Able to provide informed consent and comply with study protocol

Exclusion Criteria:

  • Significant chronic illness or end-organ dysfunction, including known history of heart failure, renal failure, pulmonary disease, or hematologic diseases.
  • Active infection or received antibiotics within 2 months of study enrollment
  • Use of OTC probiotic within past 2 months, or ingestion of yogurt within past month
  • Chronic gastrointestinal disorders, or intolerance to probiotic therapy
  • Allergies to eggs.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519310

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01519310     History of Changes
Other Study ID Numbers: 09-988
Study First Received: January 23, 2012
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
choline metabolism
gut flora
phosphatidylcholine
lecithin

Additional relevant MeSH terms:
Cardiovascular Diseases
Anti-Bacterial Agents
Ciprofloxacin
Antibiotics, Antitubercular
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 21, 2014