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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02783703
• Other study ID #: H-35267
• Status: Completed
• Phase: N/A
• Start date: April 28, 2017
• Est. completion date: June 20, 2018

Study information

• Verified date: May 2019
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 20, 2018
• Est. primary completion date: June 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Dietary Supplement:
• Medium chain triglycerides (MCT)
Subjects will consume 30 grams per 2000 kilocalories daily of medium chain triglyceride oil by mouth

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in insulin sensitivity to 6 weeks as measured by intravenous glucose tolerance test		Baseline to 6 weeks
Secondary	Change from baseline to 6 weeks in resting energy expenditure (kilocalories)		Baseline to 6 weeks
Secondary	Change from baseline to 6 weeks in body composition (% fat, muscle and bone)		Baseline to 6 weeks
Secondary	Change baseline to 6 weeks in physical activity (minutes of moderate or vigorous activity performed)		Baseline to 6 weeks
Secondary	Assessment of the following from Baseline to end of intervention: Adverse Events (AEs), Vital Signs, Anthropometrics		Baseline to 6 weeks

External Links

•   Nutrition and Weight Management Research Center