Dietary Interventions in Prediabetes

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01729078

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Impaired Fasting Glucose Pre Diabetes Liver Fat	Dietary Supplement: Dietary intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: high fat ( MUFA) diet intervention using high fat diet.	Dietary Supplement: Dietary intervention three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)
Experimental: high carb/high fiber diet using high carb-high fiber with dry beans	Dietary Supplement: Dietary intervention three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)
Experimental: high carb/low fat Habitual diet	Dietary Supplement: Dietary intervention three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)

Arm

Intervention/Treatment

Experimental: high fat ( MUFA) diet

intervention using high fat diet.

Dietary Supplement: Dietary intervention

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

Experimental: high carb/high fiber

diet using high carb-high fiber with dry beans

Dietary Supplement: Dietary intervention

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

Experimental: high carb/low fat

Habitual diet

Dietary Supplement: Dietary intervention

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

Outcome Measures

Primary Outcome Measures

Changes in liver fat content after 12 weeks of intervention [12 weeks]

Secondary Outcome Measures

Change in glucose metabolism after 12 weeks of intervention [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo clinic	Rochester	Minnesota	United States	55901

Sponsors and Collaborators

Mayo Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rita Basu, PI, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01729078

Other Study ID Numbers:

12-003216

First Posted:

Nov 20, 2012

Last Update Posted:

Jul 29, 2015

Last Verified:

Jul 1, 2015

Additional relevant MeSH terms:

Prediabetic State

Glucose Intolerance

Study Results

No Results Posted as of Jul 29, 2015