Status:
COMPLETED
Effects of Dietary Fructose on Gut Microbiota and Fecal Metabolites in Obese Men and Postmenopausal Women: A Pilot Study
Lead Sponsor:
Rockefeller University
Collaborating Sponsors:
Weill Medical College of Cornell University
National Institutes of Health (NIH)
Conditions:
Non-Alcoholic Fatty Liver Disease
Obesity
Eligibility:
All Genders
45-70 years
Phase:
NA
Brief Summary
Non alcoholic fatty liver disease (NAFLD) is the most common cause of abnormal liver function tests in the U.S. (Browning, et al., 2004), ranging from steatosis to end-stage liver disease. Fructose in...
Detailed Description
Non- alcoholic fatty liver disease (NAFLD) occurs in 30% of the adult US population (Luther, J., et al., 2015). Eating large amounts of fructose (a dietary sugar) increases liver fat accumulation and ...
Eligibility Criteria
Inclusion
- Post menopausal female, last menstrual period at least 24 months ago OR male
- Age 45-70
- Willing to consume usual diet with either fructose or glucose added during (2) 16-18 day inpatient stays
- Willing to consume usual diet during 2 week wash-out period at home
- BMI 30.0-39.9
- Willingness not to travel long distances while on study, including wash-out period
- Willingness not to be exposed to new pets while on study including wash-out period
Exclusion
- Fasting serum triglycerides \>200mg/dl
- Fasting blood glucose \>126mg/dl
- Renal function tests \>2x Upper limit of normal
- Liver Function Tests \> 1.5x Upper limit of normal
- Currently on statins
- Daily use of a cathartic
- Broad spectrum antibiotic use within the past 45 days
- Currently on proton pump inhibitor
- Currently on insulin or oral hypoglycemic agents
- Active viral Hepatitis
- Chronic constipation
- Inflammatory bowel disease
- Chronic diarrhea
- GI resection
- Any evidence of cardiovascular disease on EKG
- History of cardiovascular disease such as coronary artery disease, Coronary Artery Bypass Graft, valve replacement, Myocardial Infarction, stroke / Transient Ischemic attack.
- History of macronutrient malabsorption
- Current smoker. Stopped \< 3 months ago.
- Daily alcohol intake equal to 1.5 oz of 40 proof alcohol.
- HIV positive
- Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data
- Persons taking probiotics
Key Trial Info
Start Date :
December 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2018
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03339245
Start Date
December 5 2017
End Date
October 2 2018
Last Update
March 26 2021
Active Locations (1)
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1
The Rockefeller University
New York, New York, United States, 10065