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

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medium chain triglycerides (MCT)
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Insulin Resistance focused on measuring Hyperinsulinemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MCT

Arm Description

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

Outcomes

Primary Outcome Measures

Change from baseline in insulin sensitivity to 6 weeks as measured by intravenous glucose tolerance test

Secondary Outcome Measures

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

Full Information

First Posted
May 23, 2016
Last Updated
May 28, 2019
Sponsor
Boston Medical Center
Collaborators
Boston University
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1. Study Identification

Unique Protocol Identification Number
NCT02783703
Brief Title
Evaluation of Medium Chain Triglycerides in a Mixed Racial Population of Patients: a Feasibility Study
Official Title
Evaluation of Medium Chain Triglycerides in a Mixed Racial Population of Patients: a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 28, 2017 (Actual)
Primary Completion Date
June 20, 2018 (Actual)
Study Completion Date
June 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
Collaborators
Boston University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
Hyperinsulinemia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MCT
Arm Type
Experimental
Arm Description
Medium chain triglyceride (MCT) oil ingested daily for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Medium chain triglycerides (MCT)
Intervention Description
Subjects will consume 30 grams per 2000 kilocalories daily of medium chain triglyceride oil by mouth
Primary Outcome Measure Information:
Title
Change from baseline in insulin sensitivity to 6 weeks as measured by intravenous glucose tolerance test
Time Frame
Baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Change from baseline to 6 weeks in resting energy expenditure (kilocalories)
Time Frame
Baseline to 6 weeks
Title
Change from baseline to 6 weeks in body composition (% fat, muscle and bone)
Time Frame
Baseline to 6 weeks
Title
Change baseline to 6 weeks in physical activity (minutes of moderate or vigorous activity performed)
Time Frame
Baseline to 6 weeks
Title
Assessment of the following from Baseline to end of intervention: Adverse Events (AEs), Vital Signs, Anthropometrics
Time Frame
Baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline M Apovian, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Patient data is protected by HIPAA. Results will be published in a peer-reviewed journal.

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

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