Dietary Interventions in Prediabetes

Not Applicable

Completed

• Conditions: Liver Fat; Impaired Fasting Glucose; Pre Diabetes
• Interventions: Dietary Supplement: Dietary intervention

• Registration Number: NCT01729078
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-09
• Study First Submitted QC: 2012-11-19
• Study First Posted: 2012-11-20
• Primary Completion: 2013-10
• Study Completion: 2014-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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

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Exclusion Criteria

• MRS contraindication
• Pregnant women
• Liver disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high fat ( MUFA) diet	Dietary intervention	intervention using high fat diet.
high carb/high fiber	Dietary intervention	diet using high carb-high fiber with dry beans
high carb/low fat	Dietary intervention	Habitual diet

Primary Outcome Measures

Name	Time	Method
Changes in liver fat content after 12 weeks of intervention	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in glucose metabolism after 12 weeks of intervention	12 weeks

Trial Locations

Locations (1)

Mayo clinic; 🇺🇸 Rochester, Minnesota, United States