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CompletedNCT01729078Updated Jul 29, 2015

Dietary Interventions in Prediabetes

An interventional study of Dietary intervention in Impaired Fasting Glucose, Pre Diabetes and Liver Fat, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-07-29.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Impaired Fasting Glucose
  • Pre Diabetes
  • Liver Fat
03

In context

Glucose Intolerance

792 studies on the registry are indexed under Glucose Intolerance; 126 are open to participants now.

This study's enrollment of 48 is below the median of 60 across 656 interventional studies indexed under Glucose Intolerance.

Browse Glucose Intolerance studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,263 studies on the registry; 670 are open to participants now.

Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.

Browse Mayo Clinic studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • MRS contraindication
  • Pregnant women
  • Liver disease
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    high fat ( MUFA) diet

    intervention using high fat diet.

    Dietary Supplement: Dietary intervention

  • Experimental
    high carb/high fiber

    diet using high carb-high fiber with dry beans

    Dietary Supplement: Dietary intervention

  • Experimental
    high carb/low fat

    Habitual diet

    Dietary Supplement: 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)

06

What researchers measure

Primary outcomes

  1. Changes in liver fat content after 12 weeks of intervention

    Time frame: 12 weeks

Secondary outcomes

  1. Change in glucose metabolism after 12 weeks of intervention

    Time frame: 12 weeks

07

Study locations

1 site
  • Mayo clinic
    Rochester, Minnesota 55901, United States
08

References and documents

Publications

  • Errazuriz I, Dube S, Slama M, Visentin R, Nayar S, O'Connor H, Cobelli C, Das SK, Basu A, Kremers WK, Port J, Basu R. Randomized Controlled Trial of a MUFA or Fiber-Rich Diet on Hepatic Fat in Prediabetes. J Clin Endocrinol Metab. 2017 May 1;102(5):1765-1774. doi: 10.1210/jc.2016-3722. PubMed 28323952 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2012, a primary completion of Oct 2013 and a completion of Feb 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2012
First posted
Nov 20, 2012
Start
Oct 2012
Primary completionActual
Oct 2013
CompletionActual
Feb 2014
Last update
Jul 29, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01729078
Lead sponsor
Mayo Clinic
Responsible party
Rita Basu (PI, Mayo Clinic) — Principal investigator
First posted
Nov 20, 2012
Start date
Oct 2012
Primary completion
Oct 2013
Completion
Feb 2014
Last update
Jul 29, 2015
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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