Effect of a Medium Chain Triglyceride Supplemented Diet on Cognitive Function and Brain Activation in Type 1 Diabetes.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01315171
Recruitment Status : Completed
First Posted : March 15, 2011
Last Update Posted : January 17, 2018
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Yale University

March 11, 2011
March 15, 2011
January 17, 2018
January 2012
August 2015   (Final data collection date for primary outcome measure)
Cognitive function tests [ Time Frame: 100 minutes ]
Cognitive function will be assessed during hypoglycemia. 3 tests will be carried looking at working memory with number and word recollection.
Same as current
Complete list of historical versions of study NCT01315171 on Archive Site
Brain activity [ Time Frame: 100 minutes ]
The fMRI will be used to assess brain activity during hypoglycemia in the presence of medium chain triglycerides.
Same as current
Not Provided
Not Provided
Effect of a Medium Chain Triglyceride Supplemented Diet on Cognitive Function and Brain Activation in Type 1 Diabetes.
The Effect of a Long-term Medium Chain Supplemented Diet on Cognitive Function and Brain Activation During Hypoglycemia in Type 1 Diabetes.
Insulin treatment often causes the blood glucose levels to fall too low (hypoglycemia). Hypoglycemia can be associated with confusion and disorientation as well as other symptoms such as palpitations, sweating and tremors. Medium chain triglycerides (MCT) can be used as a fuel in the brain during low blood sugar levels and therefore may prevent or reduce some of the confusion and disorientation seen during hypoglycemia. We would like to determine if a diet supplemented with medium chain triglycerides can improve cognitive function during hypoglycemia, diabetes control and also look at brain activity.
30 subjects with well controlled type 1 diabetes will be recruited for the study. If you agree to participate you will be scheduled for, dietitian visits, and a study visit which will include insulin and glucose infusions, an MRI scan and brain function tests. All visits will be on the Hospital Research Unit (HRU) on the 10th floor of Yale New Haven Hospital. You will be randomized to either the MCT-supplemented diet or the standardized western diabetic diet. If you are on the MCT diet, the MCT oil will be given to you and you will be shown how to incorporate it into your diet. The MCT supplemented diet is for two weeks (with a two gradual transition onto the diet) and the standardized western diet is for two weeks (with a 1 week transition onto the diet). At the end of the study you will be admitted to the Hospital Research Unit for the insulin 'clamp' and MRI scan. A 'clamp' is a procedure which involves insulin and glucose infusions. During a 'clamp' study, the insulin infusion is held constant, while the glucose infusion is adjusted every 5 minutes as needed to maintain the desired blood glucose levels. Compensation for the study is $750.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hypo-unawareness
  • Type 1 Diabetes Mellitus
Dietary Supplement: Medium chain triglycerides
4 tablespoons/day for 2 weeks
  • Experimental: Medium chain supplemented diet
    Subjects will have a diet during which all meals are supplemented with 4 tablespoons of medium chain triglyceride oil.
    Intervention: Dietary Supplement: Medium chain triglycerides
  • No Intervention: Standard group
    Subjects will continue with a standard western diabetes diet.
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2016
August 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • type 1 diabetes
  • HbA1c <8%
  • BMI 18-30
  • hypo unawareness

Exclusion Criteria:

  • pregnancy
  • significant diabetes complications
  • liver disease, cirrhosis
  • cardiac disease
  • neurological disorder
  • kidney disease
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Yale University
Yale University
Juvenile Diabetes Research Foundation
Principal Investigator: Robert Sherwin, MD Yale University
Yale University
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP