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

NCT ID: NCT02783703

Last Updated: 2019-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-28
• Study Completion Date: 2018-06-20

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.

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.

Conditions

Insulin Resistance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MCT

Medium chain triglyceride (MCT) oil ingested daily for 6 weeks

Group Type: EXPERIMENTAL

Medium chain triglycerides (MCT)

Intervention Type: DIETARY_SUPPLEMENT

Subjects will consume 30 grams per 2000 kilocalories daily of medium chain triglyceride oil by mouth

Interventions

Medium chain triglycerides (MCT)

Subjects will consume 30 grams per 2000 kilocalories daily of medium chain triglyceride oil by mouth

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University

OTHER

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Caroline Apovian

BMC Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caroline M Apovian, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-35267

Identifier Type: -

Identifier Source: org_study_id