NCT01729078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

November 9, 2012

Last Update Submit

July 27, 2015

Conditions

Impaired Fasting GlucosePre DiabetesLiver Fat

Outcome Measures

Primary Outcomes (1)

  • Changes in liver fat content after 12 weeks of intervention

    12 weeks

Secondary Outcomes (1)

  • Change in glucose metabolism after 12 weeks of intervention

    12 weeks

Study Arms (3)

high fat ( MUFA) diet

EXPERIMENTAL

intervention using high fat diet.

Dietary Supplement: Dietary intervention

high carb/high fiber

EXPERIMENTAL

diet using high carb-high fiber with dry beans

Dietary Supplement: Dietary intervention

high carb/low fat

EXPERIMENTAL

Habitual diet

Dietary Supplement: Dietary intervention

Interventions

Dietary interventionDIETARY_SUPPLEMENT

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

high carb/high fiberhigh carb/low fathigh fat ( MUFA) diet

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • MRS contraindication
  • Pregnant women
  • Liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo clinic

Rochester, Minnesota, 55901, United States

Location

Related Publications (1)

  • 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.

    PMID: 28323952DERIVED

MeSH Terms

Conditions

Glucose IntoleranceFatty Liver

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

November 9, 2012

First Posted

November 20, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

February 1, 2014

Last Updated

July 29, 2015

Record last verified: 2015-07

Locations

US(1)