CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13 enrolled
Drug / intervention
Fructose Solution (75 Grams) +1 moreother
Likely dose
Fructose 75 grams in divided doses (breakfast and dinner) or Glucose 75 grams in divided doses (breakfast and dinner)AI-extracted
Key inclusion· 5
  • Postmenopausal women (≥24 months since last menstrual period) or men
  • Age 45-70 years
  • BMI 30.0-39.9 kg/m²
  • Willing to participate in two 16-18 day inpatient stays with study diet (fructose or glucose added to usual diet)
Key exclusion· 13
  • Fasting serum triglycerides >200 mg/dL
  • Fasting blood glucose >126 mg/dL (diabetes)
  • Renal dysfunction (renal function tests >2× upper limit of normal)
  • Liver dysfunction (liver function tests >1.5× upper limit of normal)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03339245
NCT03339245N/ACompleted

Effects of Dietary Fructose on Gut Microbiota and Fecal Metabolites in Obese Men and Postmenopausal Women: A Pilot Study

Rockefeller University·interventional·Posted Nov 13, 2017·Updated Mar 26, 2021

In Brief

A clinical study evaluating Fructose Solution (75 Grams) and Glucose Solution (75 grams) for Non-Alcoholic Fatty Liver Disease and Obesity. Completed, enrolled 13 participants across 1 site.

Detailed 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 ingestion by the American public has steadily increased since the 1980's, and with it increases in NAFLD, fatty liver hepatitis (NASH), diabetes, obesity, and cardiovascular disease. Foods and beverage in the U.S. are typically sweetened with sucrose (50% glucose and 50% fructose) or high fructose corn syrup (45-58% glucose and 42-55% fructose) (Stanhope, et al., 2009). Research into the role that added fructose plays in the emerging chronic health issues is necessary to affect public policy and provide the connection between fructose and the increasing incidence of these co-morbidities. There is evidence that gut bacteria contribute to a range of human diseases including those of the liver and gastrointestinal tract. Dietary fructose has been suggested to play a role in the development of these diseases and has been shown to alter gut microbes in animals. If the investigators find that dietary fructose alters bacteria in the human gut, this would suggest a potential targetable link between high fructose diet and disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 13, 2017
Enrollment StartDec 5, 2017
Primary CompletionOct 2, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.6 years ago

Interventions

Fructose Solution (75 Grams)other

Fructose given in divided doses at breakfast and dinner.

Glucose Solution (75 grams)other

Glucose given in divided doses at breakfast and dinner.