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

• Sponsor: Boston Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02783703
• Collaborator: Boston University (Other)
• Enrollment: 24
• Location: 1
• Arm: 1
• Actual Duration (Months): 13.7
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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)	N/A

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 Design

• Study Type: Interventional
• 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: Apr 28, 2017
• Actual Primary Completion Date: Jun 20, 2018
• Actual Study Completion Date: Jun 20, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change from baseline in insulin sensitivity to 6 weeks as measured by intravenous glucose tolerance test [Baseline to 6 weeks]

Secondary Outcome Measures

1. Change from baseline to 6 weeks in resting energy expenditure (kilocalories) [Baseline to 6 weeks]

2. Change from baseline to 6 weeks in body composition (% fat, muscle and bone) [Baseline to 6 weeks]

3. Change baseline to 6 weeks in physical activity (minutes of moderate or vigorous activity performed) [Baseline to 6 weeks]

4. Assessment of the following from Baseline to end of intervention: Adverse Events (AEs), Vital Signs, Anthropometrics [Baseline to 6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Medical Center	Boston	Massachusetts	United States	02118

Sponsors and Collaborators

• Boston Medical Center
• Boston University

Investigators

• Principal Investigator: Caroline M Apovian, MD, Boston Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Caroline Apovian, BMC Faculty, Boston Medical Center
• ClinicalTrials.gov Identifier: NCT02783703
• Other Study ID Numbers: H-35267
• First Posted: May 26, 2016
• Last Update Posted: May 30, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Caroline Apovian, BMC Faculty, Boston Medical Center: Hyperinsulinemia
• Additional relevant MeSH terms: Insulin Resistance

Study Results

No Results Posted as of May 30, 2019