Fuel Utilization, Diet Composition, and Exercise in African American Women
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|ClinicalTrials.gov Identifier: NCT04293367|
Recruitment Status : Completed
First Posted : March 3, 2020
Last Update Posted : March 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Obesity Diabetes Insulin Resistance||Other: High Intensity Interval Training (HIIT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The study team will conduct a randomized clinical trial in 48 healthy pre-menopausal sedentary overweight and obese African American women. The women will be randomized to two groups: a) half of the women in each diet group will be training (EX) and b) half of the women in each diet group will be sedentary (C). Each woman will participate over a 5 months period, through 4 menstrual cycles so that baseline and post-intervention measurements are done during the follicular phase of the menstrual cycle. The baseline and post-intervention measurements will be done after a 10-day period of controlled eucaloric High-Fat feeding. On Days 9-11 of the 10 -day period they will be in-patients in the CRR and they will all be sedentary. On Day 9 they will be admitted to the Metabolic Chamber and have 24-hour energy expenditure measurements as previously described which will be used for the diet on subsequent days in the CRR. On Day 10 they will be fed the same amount of calories they bu|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Potential subjects will be from an African American descent which will be defined as having all four grandparents reported as African Americans. The subjects will be healthy (blood work, Hx and PE), non-diabetic (OGTT) pre-menopausal, age range 20-40 years, BMI range of 25-40, with regular menstrual periods, sedentary (exercise no more than 2 times/week, for one hour or spend no more than 1000 - 1500 Kcal/wk in physical activity as determined by a Paffenbarger questionnaire). Subjects will be excluded if there is any indication what so ever that they have any cardiac or pulmonary illnesses which may interfere with their capacity to exercise, if they are smokers, consume more than 2 oz. of ethanol/day, have had a weight change greater than + 2 kg in the past 3 months, are currently taking medications or have any physical conditions which may affect insulin action and/or lipid metabolism or have hyperlipidemia.|
|Official Title:||Fuel Utilization, Diet Composition, and Exercise in African American Women|
|Actual Study Start Date :||June 1, 2009|
|Actual Primary Completion Date :||April 16, 2013|
|Actual Study Completion Date :||November 20, 2013|
14 African American Women with obesity will be randomly assigned to the 14-week high intensity interval training program
Other: High Intensity Interval Training (HIIT)
HIIT involves exercising in blocks of time (typically 4-5 minutes) where a small percentage of the time (typically 1 minute) is spent above the anaerobic (lactate) threshold (the "work interval") followed by the remainder of the time at a sub-anaerobic threshold ("active recovery").
No Intervention: Control
14 African American Women with obesity will be randomly assigned to serve as a reference group, i.e. follow the same protocol as the experimental group, however, they will not undergo exercise training
- Change in Post-absorptive Lipid Oxidation [ Time Frame: Baseline and 14 weeks ]Resting ventilatory and gas exchange measurements will be done using indirect calorimetry using open circuit gas analysis at baseline and post intervention. Measurements and calculations for substrate utilization will be done as described and published using before and will be expressed as µmoles/KgFFM/min.
- Fitness (VO2peak) [ Time Frame: up to 14 weeks ]All subjects will perform an incremental cycle ergometry test, at baseline and post intervention. The tests will be done before the 10-day eucaloric dietary challenges periods and data will be also used to determine the dietary prescription.
- Glucose Disposal Rate (GDR) during the Hyperinsulinemic-Euglycemic Clamp [ Time Frame: up to 14 weeks ]The subjects will be admitted at the CRR's inpatient physiology room to perform a Hyperinsulinemic-Euglycemic Clamp . The protocol used will be specific for measurements of insulin- mediated glucose disposal of the muscle. For 3 hours, plasma insulin concentration will be raised to around 200µU/ml using an insulin infusion of 80mU/m2 and the investigators will maintain euglycemia at around 100 mg/dl plasma glucose using a variable infusion of exogenous glucose of known concentration (20% glucose). Hepatic glucose production is expected to be completely suppressed at this level of insulin for these obese, but otherwise generally healthy women.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04293367
|United States, New York|
|Mount Sinai St. Luke's Clinical Research Unit|
|New York, New York, United States, 10025|
|Principal Investigator:||Jeanine Albu||Icahn School of Medicine at Mount Sinai|