Dietary Interventions in Prediabetes

The Effects of Dietary Supplementation on Hepatic Insulin Action and Glucose Tolerance in Pre-diabetes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01729078

Enrollment

Registered

2012-11-20

Start date

2012-10-31

Completion date

2014-02-28

Last updated

2015-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impaired Fasting Glucose, Liver Fat, Pre Diabetes

Brief summary

Assessment of glucose metabolism and liver fat after 12 week dietary intervention in pre diabetes subjects. Subjects will be randomized to either high fat (olive oil supplemented),high carb/high fiber (beans supplemented) and high carb/low fiber diets. Glucose metabolism will be assessed by labeled oral glucose tolerance test and liver fat by magnetic resonance spectroscopy pre randomization and at 8 and 12 week after starting dietary intervention.

Interventions

DIETARY_SUPPLEMENTDietary intervention

three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Impaired fasting glucose(100-125 mg/dl) * HbA1c 5.7-6.4 % * BMI 26-40 kg/sq.m

Exclusion criteria

* MRS contraindication * Pregnant women * Liver disease

Design outcomes

Primary

Measure	Time frame
Changes in liver fat content after 12 weeks of intervention	12 weeks

Secondary

Measure	Time frame
Change in glucose metabolism after 12 weeks of intervention	12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026