Fuel Utilization, Diet Composition, and Exercise in African American Women

NCT04293367 | Completed

• 2 other identifiers: SLR 1-10-CT-01#: 1-10-CT-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

African American women have a high prevalence of obesity and type 2 diabetes and do not optimally burn fat and carbohydrates in response to changes in these nutrients in their diets. This research project seek to determine if high intensity interval training (HIIT) exercise training can help healthy, but inactive, premenopausal, non-diabetic women increase their bodies' use of fat and carbohydrates when provided with a high fat or low fat diets. In this study, investigators will measure the rate at which fat is burned in response to weight maintaining low-fat and high-fat diets and how exercise may affect these responses.

Conditions

Obesity; Diabetes; Insulin Resistance

Keywords

Obesity; Prediabetes; metabolic flexibility; insulin sensitivity; high-intensity interval training; exercise tolerance

Outcome Measures

Primary Outcomes (1)

• Change in Post-absorptive Lipid Oxidation

  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.

  Baseline and 14 weeks

Secondary Outcomes (2)

• Fitness (VO2peak)

  up to 14 weeks

• Glucose Disposal Rate (GDR) during the Hyperinsulinemic-Euglycemic Clamp

  up to 14 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

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)

Control

NO INTERVENTION

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

Interventions

High Intensity Interval Training (HIIT) OTHER

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").

Exercise

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• African American descent and all four grandparents reported as African Americans
• DNA will also be collected so admixture could be measured post study
• Reported good health (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).

You may not qualify if:

• Any cardiac or pulmonary illnesses which may interfere with their capacity to exercise
• Active smoker
• Consume more than 2 oz. of ethanol/day
• Weight change greater than + 2 kg in the past 3 months
• Currently taking medications or have any physical conditions which may affect insulin action and/or lipid metabolism or have hyperlipidemia (plasma triglyceride greater than or equal to 350 mg/dl or total cholesterol levels greater than or equal to 300 mg/dl).
• Metal implants (ex: pacemaker, implanted jewelry, etc)
• The subjects' usual diets will be evaluated by the Block 98.2 Food Frequency Questionnaire (BDDS, Berkeley, CA).

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai St. Luke's Clinical Research Unit

New York, New York, 10025, United States

Location

Related Publications (1)

• Arad AD, Albu JB, DiMenna FJ. Feasibility of a progressive protocol of high-intensity interval training for overweight/obese, sedentary African American women: a retrospective analysis. BMC Sports Sci Med Rehabil. 2020 Sep 21;12:59. doi: 10.1186/s13102-020-00207-7. eCollection 2020.

  PMID: 32974034 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Insulin Resistance; Prediabetic State

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jeanine Albu

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 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

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 3, 2020
• Study Start: June 1, 2009
• Primary Completion: April 16, 2013
• Study Completion: November 20, 2013
• Last Updated: March 3, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)