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

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance
• Intervention / Treatment: Dietary supplement: Medium chain triglycerides (MCT)

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in insulin sensitivity to 6 weeks as measured by intravenous glucose tolerance test	Baseline to 6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Boston University
• Investigators: Principal Investigator: Caroline M Apovian, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2017
• Primary Completion (Actual): June 20, 2018
• Study Completion (Actual): June 20, 2018

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): May 26, 2016

Study Record Updates

• Last Update Posted (Actual): May 30, 2019
• Last Update Submitted That Met QC Criteria: May 28, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Hyperinsulinemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: H-35267

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patient data is protected by HIPAA. Results will be published in a peer-reviewed journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No