Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Medium Chain Triglycerides in a Mixed Racial Population of Patients: a Feasibility Study

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.
 
ClinicalTrials.gov Identifier: NCT02783703
Recruitment Status : Completed
First Posted : May 26, 2016
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
Boston University
Information provided by (Responsible Party):
Caroline Apovian, Boston Medical Center

Brief Summary:
The study team will investigate the racial differences in the metabolic and clinical responses to Medium chain triglycerides (MCT) between African American and Caucasian American subjects.

Condition or disease Intervention/treatment Phase
Insulin Resistance Dietary Supplement: Medium chain triglycerides (MCT) Not Applicable

Detailed Description:
It is generally accepted that type 2 diabetes (T2D) arises from the progression of insulin resistance (IR), with hyperinsulinemia (HI) as a compensatory response. The possibility that HI can precede and contribute to insulin resistance (IR) and metabolic syndrome (MS) has been suggested but not tested in humans. While IR and HI are closely associated, demonstrating a primary role for HI in T2D is key to the development of new treatment strategies for this disease. One group in which HI could play a bigger role in T2D is African Americans (AA) who are known to be more hyperinsulinemic than Caucasian Americans (CA). Racial disparities in T2D treatment outcomes adversely affect AA. Our main hypothesis is that suppression of HI will contribute to the prevention and treatment of T2D, especially among AA. Our goal in this pilot study is to show that consumption of medium chain triglycerides (MCT) in the diet will decrease basal insulin secretion and HI, and will lead to improvement in the insulin sensitivity index (Si). 24 subjects (12 AA, 12 CA) will participate in a clinical trial in which they will receive MCT for 6 weeks. Insulin secretion dynamics and insulin sensitivity will be assessed by use of the frequently sampled intravenous glucose tolerance test (FSIVGTT) and Bergman's minimal model analysis.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Medium Chain Triglycerides in a Mixed Racial Population of Patients: a Feasibility Study
Actual Study Start Date : April 28, 2017
Actual Primary Completion Date : June 20, 2018
Actual Study Completion Date : June 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MCT
Medium chain triglyceride (MCT) oil ingested daily for 6 weeks
Dietary Supplement: Medium chain triglycerides (MCT)
Subjects will consume 30 grams per 2000 kilocalories daily of medium chain triglyceride oil by mouth




Primary Outcome Measures :
  1. Change from baseline in insulin sensitivity to 6 weeks as measured by intravenous glucose tolerance test [ Time Frame: Baseline to 6 weeks ]

Secondary Outcome Measures :
  1. Change from baseline to 6 weeks in resting energy expenditure (kilocalories) [ Time Frame: Baseline to 6 weeks ]
  2. Change from baseline to 6 weeks in body composition (% fat, muscle and bone) [ Time Frame: Baseline to 6 weeks ]
  3. Change baseline to 6 weeks in physical activity (minutes of moderate or vigorous activity performed) [ Time Frame: Baseline to 6 weeks ]
  4. Assessment of the following from Baseline to end of intervention: Adverse Events (AEs), Vital Signs, Anthropometrics [ Time Frame: Baseline to 6 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English-speaking
  • Males and female ambulatory subjects
  • Self-identify as Caucasian/White or Black/African American
  • Body Mass Index <=45

Exclusion Criteria:

  • Diagnosis of type 2 diabetes or hemoglobin A1c >6.5
  • Use of insulin, oral hypoglycemic, agents, or insulin-sensitizing agents
  • Daily use of oral steroids
  • Unstable weight within 3 months prior to baseline (e.g., weight gain or loss of >3%)
  • Use of any weight loss medications or sex hormone therapy
  • Daily use of psychotropic medications (for schizophrenia, bipolar disorder, obsessive compulsive disorder, posttraumatic stress disorder, psychotic disorder, mania)
  • Chronic kidney disease, on dialysis or history of renal transplant
  • Poorly controlled cardiovascular disease or congestive heart failure
  • Severe peripheral vascular disease or severe liver disease
  • Cancer
  • A condition requiring use of oxygen such as severe chronic obstructive pulmonary disease
  • Women who are pregnant, lactating, or actively trying to become pregnant
  • Any cognitive or other disorders that may interfere with participation or ability to follow restrictions
  • Abnormal TSH levels (<0.01 or >1.5x the upper limit)
  • Weight >450 lb (205 kg) or height > 6'6"
  • Severe claustrophobia
  • Has had or is preparing for bariatric surgery (pre- or post-bariatric)
  • Medically required use of anticoagulant therapies
  • Current use of MCT oil
  • Anemia (hemoglobin and/or hematocrit outside sex-specific normal ranges)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783703


Locations
Layout table for location information
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Boston University
Investigators
Layout table for investigator information
Principal Investigator: Caroline M Apovian, MD Boston Medical Center
Additional Information:
Layout table for additonal information
Responsible Party: Caroline Apovian, BMC Faculty, Boston Medical Center
ClinicalTrials.gov Identifier: NCT02783703    
Other Study ID Numbers: H-35267
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patient data is protected by HIPAA. Results will be published in a peer-reviewed journal.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Caroline Apovian, Boston Medical Center:
Hyperinsulinemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases