ObesityNCT04293367
Fuel Utilization, Diet Composition, and Exercise in African American Women
A study testing High Intensity Interval Training (HIIT) in people with Obesity and Diabetes, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes, Insulin Resistance
- What is being tested?
- High Intensity Interval Training (HIIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2009to 20 Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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)
- 1st degree family history of type diabetes 2 diabetes (Will be noted but will not constitute an exclusionary criteria).
- The subjects' usual diets will be evaluated by the Block 98.2 Food Frequency Questionnaire (BDDS, Berkeley, CA).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai St. Luke's Clinical Research Unit
New York, New York, 10025
About this study
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.
Read the detailed description
African Americans have the highest age-adjusted death rate for heart disease and diabetes in the United States. Obesity, a significant risk factor for these conditions, is highly prevalent in African Americans, particularly women, leading to increased co-morbidities. Cardiovascular risk and incidence were reported to be higher in African American women than in both white women and African American men. Ethnic differences in lifestyle behaviors and economic disadvantage account for some of this disparity but genetic/molecular factors may play a role. The study team has shown that more pre-menopausal, non-diabetic, African American women do not increase post-absorptive lipid oxidation in response to a eucaloric increase in dietary fat than white women counterparts. African American women were also shown to have increased rates of low aerobic capacity (VO2peak) and insulin resistance.
A lack of increasing fuel utilization in response to an increase in fuel availability, particularly fat, is associated with obesity and insulin resistance and is attributed to a decrease in the oxidative capacity of the skeletal muscle. An eucaloric increase in dietary fat leads to increased post-absorptive lipid utilization through hormonal changes that affect the mitochondria and a decrease in this response is postulated to reflect a decrease in the mitochondria/oxidative capacity. Lipid utilization in response to an increase in dietary fat is enhanced by acute exercise. Aerobic training could also improve aerobic capacity and insulin resistance and increases the oxidative capacity/mitochondrial activity in the skeletal muscle, measured in vitro. The degree to which training affects aerobic capacity and metabolism differs with the type, intensity and duration of training and with the population studied. High-intensity interval training (HIIT) programs improved aerobic fitness and insulin resistance in cardiac, sedentary and obese individuals and rapidly increased markers of lipid oxidation and mitochondrial activity in skeletal muscle, measured in vitro. A great appeal of HIIT is that lesser time per week spent exercising may be needed to produce these effects. There have been a paucity of effective exercise training studies in African American women; none have employed HIIT which appears uniquely suited given their metabolic profile and none have examined the impact of training on the metabolic response to an increase in dietary fat.
Therefore the Aims of this study are to determine, in overweight and obese, sedentary, pre-menopausal, non-diabetic African American women, whether a 14-week of a HIIT exercise program will:
- Increase systemic post-absorptive lipid oxidation in response to a higher fat diet (50% fat, 35% CHO, 15% protein). The study team hypothesizes that the women who successfully complete training will have significantly higher post-absorptive lipid oxidation in response to the higher fat diet compared to the sedentary controls on a similar diet.
II. Improve aerobic endurance capacity. The study team hypothesizes that VO2peak will be significantly higher in the women who successfully complete training compared to the sedentary controls.
III. Improve insulin sensitivity. The study team hypothesizes that insulin sensitivity will be significantly higher in the women who successfully complete training compared to the sedentary controls.
Te secondary aims are to determine whether: 1) the exercise training favorably changes muscle adipose tissue distribution and lipid accumulation and 2) these changes correlate with an improvement in insulin sensitivity.
To test these hypotheses The study team will conduct a clinical trial in 48 pre-menopausal, healthy, sedentary, overweight and obese African American women. All women will be challenged with a 10-day eucaloric higher fat diet. Then, half of the women will be randomized to participate in a 14-week HIIT program designed to significantly increase their aerobic endurance and half will maintain baseline physical activity. Throughout the follow period all women will be counseled to follow the same, weight-maintaining, heart-healthy diet. After 14 weeks the higher fat dietary challenges will be repeated, at weight stability ensured with the use of the whole-body calorimeter (metabolic chamber). Post-absorptive lipid oxidation, insulin sensitivity and muscle-associated fat will be measured at the end of each of the higher fat diet periods, before and after the 14 weeks of exercise raining, in the sedentary and exercising women, 2 days after the last bout of acute exercise.
HIIT has a greater potential for translation into clinical practice as the shorter exercise time may improve compliance which is the biggest deterrent for the success of exercise training programs. Prevention of obesity and reversal of decreased aerobic capacity and insulin resistance in younger individuals such as African American women of child-bearing age (pre-menopausal) could be crucial to decrease the worrisome trends of obesity-related illnesses in African Americans.
- Conditions
- Obesity, Diabetes, Insulin Resistance
- Being tested
- High Intensity Interval Training (HIIT)
- Keywords
- Obesity, Prediabetes, metabolic flexibility, insulin sensitivity, high-intensity interval training, exercise tolerance
- Medical subject headings
- Obesity, Diabetes Mellitus, Insulin Resistance, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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").
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 14 African American Women with obesity will be randomly assigned to the 14-week high intensity interval training program Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 14 weeks
Secondary outcomes (2)
Fitness (VO2peak)
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.
Measured: up to 14 weeks
Glucose Disposal Rate (GDR) during the Hyperinsulinemic-Euglycemic Clamp
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.
Measured: up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Jun 2009
- Primary completion16 Apr 2013
- Study completion20 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeanine Albu, Icahn School of Medicine at Mount Sinai
- Investigators
- Jeanine Albu, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293367
- Sponsor's protocol ID
- SLR 1-10-CT-01
- Other IDs
- #: 1-10-CT-01
- Status last verified
- Feb 2020
- First submitted
- 28 Feb 2020
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32974034
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fuel Utilization, Diet Composition, and Exercise in African American Women
- ClinicalTrials.gov ID
- NCT04293367
- Acronym / sponsor ID
- SLR 1-10-CT-01
- Conditions
- Obesity, Diabetes, Insulin Resistance
- Keywords
- Obesity, Prediabetes, metabolic flexibility, insulin sensitivity, high-intensity interval training, exercise tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 1 Jun 2009 (actual)
- Primary completion
- 16 Apr 2013 (actual)
- Study completion
- 20 Nov 2013 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
African Americans have the highest age-adjusted death rate for heart disease and diabetes in the United States. Obesity, a significant risk factor for these conditions, is highly prevalent in African Americans, particularly women, leading to increased co-morbidities. Cardiovascular risk and incidence were reported to be higher in African American women than in both white women and African American men. Ethnic differences in lifestyle behaviors and economic disadvantage account for some of this disparity but genetic/molecular factors may play a role. The study team has shown that more pre-menopausal, non-diabetic, African American women do not increase post-absorptive lipid oxidation in response to a eucaloric increase in dietary fat than white women counterparts. African American women were also shown to have increased rates of low aerobic capacity (VO2peak) and insulin resistance.
A lack of increasing fuel utilization in response to an increase in fuel availability, particularly fat, is associated with obesity and insulin resistance and is attributed to a decrease in the oxidative capacity of the skeletal muscle. An eucaloric increase in dietary fat leads to increased post-absorptive lipid utilization through hormonal changes that affect the mitochondria and a decrease in this response is postulated to reflect a decrease in the mitochondria/oxidative capacity. Lipid utilization in response to an increase in dietary fat is enhanced by acute exercise. Aerobic training could also improve aerobic capacity and insulin resistance and increases the oxidative capacity/mitochondrial activity in the skeletal muscle, measured in vitro. The degree to which training affects aerobic capacity and metabolism differs with the type, intensity and duration of training and with the population studied. High-intensity interval training (HIIT) programs improved aerobic fitness and insulin resistance in cardiac, sedentary and obese individuals and rapidly increased markers of lipid oxidation and mitochondrial activity in skeletal muscle, measured in vitro. A great appeal of HIIT is that lesser time per week spent exercising may be needed to produce these effects. There have been a paucity of effective exercise training studies in African American women; none have employed HIIT which appears uniquely suited given their metabolic profile and none have examined the impact of training on the metabolic response to an increase in dietary fat.
Therefore the Aims of this study are to determine, in overweight and obese, sedentary, pre-menopausal, non-diabetic African American women, whether a 14-week of a HIIT exercise program will:
- Increase systemic post-absorptive lipid oxidation in response to a higher fat diet (50% fat, 35% CHO, 15% protein). The study team hypothesizes that the women who successfully complete training will have significantly higher post-absorptive lipid oxidation in response to the higher fat diet compared to the sedentary controls on a similar diet.
II. Improve aerobic endurance capacity. The study team hypothesizes that VO2peak will be significantly higher in the women who successfully complete training compared to the sedentary controls.
III. Improve insulin sensitivity. The study team hypothesizes that insulin sensitivity will be significantly higher in the women who successfully complete training compared to the sedentary controls.
Te secondary aims are to determine whether: 1) the exercise training favorably changes muscle adipose tissue distribution and lipid accumulation and 2) these changes correlate with an improvement in insulin sensitivity.
To test these hypotheses The study team will conduct a clinical trial in 48 pre-menopausal, healthy, sedentary, overweight and obese African American women. All women will be challenged with a 10-day eucaloric higher fat diet. Then, half of the women will be randomized to participate in a 14-week HIIT program designed to significantly increase their aerobic endurance and half will maintain baseline physical activity. Throughout the follow period all women will be counseled to follow the same, weight-maintaining, heart-healthy diet. After 14 weeks the higher fat dietary challenges will be repeated, at weight stability ensured with the use of the whole-body calorimeter (metabolic chamber). Post-absorptive lipid oxidation, insulin sensitivity and muscle-associated fat will be measured at the end of each of the higher fat diet periods, before and after the 14 weeks of exercise raining, in the sedentary and exercising women, 2 days after the last bout of acute exercise.
HIIT has a greater potential for translation into clinical practice as the shorter exercise time may improve compliance which is the biggest deterrent for the success of exercise training programs. Prevention of obesity and reversal of decreased aerobic capacity and insulin resistance in younger individuals such as African American women of child-bearing age (pre-menopausal) could be crucial to decrease the worrisome trends of obesity-related illnesses in African Americans.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: High Intensity Interval Training (HIIT)14 African American Women with obesity will be randomly assigned to the 14-week high intensity interval training program |
| 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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"). | Other | Exercise |
Primary outcome
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.
2 secondary outcomes
Fitness (VO2peak)
Time frame: up to 14 weeks
Glucose Disposal Rate (GDR) during the Hyperinsulinemic-Euglycemic Clamp
Time frame: up to 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Derived from this study: PubMed 32974034Arad 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanine Albu principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training (HIIT) in people with Obesity and Diabetes, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Post-absorptive Lipid Oxidation (time frame: Baseline and 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04293367, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.