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

NCT02783703 | Completed

• 1 other identifier: H-35267
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance

Keywords

Hyperinsulinemia

Outcome Measures

Primary Outcomes (1)

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

  Baseline to 6 weeks

Secondary Outcomes (4)

• 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

Study Arms (1)

MCT

EXPERIMENTAL

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

Dietary Supplement: Medium chain triglycerides (MCT)

Interventions

Medium chain triglycerides (MCT) DIETARY_SUPPLEMENT

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

MCT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking
• Males and female ambulatory subjects
• Self-identify as Caucasian/White or Black/African American
• Body Mass Index \<=45

You may not qualify if:

• 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"

Sponsors & Collaborators

• Boston Medical Center: lead
• Boston University: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Hyperinsulinism

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Caroline M Apovian, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BMC Faculty

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: May 26, 2016
• Study Start: April 28, 2017
• Primary Completion: June 20, 2018
• Study Completion: June 20, 2018
• Last Updated: May 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)