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poor enrollment
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This study will enroll and randomly assign 30 sedentary, healthy overweight men and women to two groups. Participants will either start by consuming peanuts for 4 weeks, and then go on to exercise at high intensity intervals (HIIT) for 4 weeks, or the reverse order. The study will test and compare the effect of peanuts and exercise on inflammation and heart rate variability as indicators of heart health. Specifically, the study will measure inflammation in the blood because there is evidence that higher inflammation is found in heart disease patients. There is also evidence that inflammation is related to death as a result of heart disease in healthy individuals. Finally, there are ongoing trials targeting these markers to improve heart health. The study hypothesizes that peanuts and exercise will reduce inflammation. It is also expected to find less inflammation because exercise and peanut consumption activate a part of the nervous system that has been shown to cause a similar effect.
Additionally, previous studies show that inflammation involves the mitochondria in the cell, the part of the cell that produces energy. For this reason, it is expected that exercise and peanuts will cause changes in the mitochondria. The study will test and compare mitochondrial activity in response to peanut consumption and exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Intensity Interval Training then Peanut Consumption | Experimental | Exercise group: 4 training sessions/week, 24 hour rest-periods between each training day. 3-min low intensity warm-up, and then exercise as rapidly as possible for 20 seconds, aiming to reach 85% of their maximum heart rate established during the submaximal cardiopulmonary exercise testing. Then followed by 40 seconds of low intensity exercise. Peanut group: Regular daily caloric intake estimated using data from 24hr recalls, the Miflin-St. Jeor equation, and stress/activity factors. Participants consume dry roasted, unsalted peanuts equivalent to approximately 10% of daily energy intake twice a day, range from approximately 2.4-3.6 ounces. Daily caloric intake will not differ from participants' typical diet. Participants are asked to bring back the empty, numbered peanut packets by the end of every week and will be given new packets weekly. Additionally, subjects will be informed that they will be randomly assessed weekly for compliance. |
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| Peanut Consumption then High Intensity Interval Training | Experimental | Exercise group: 4 training sessions/week, 24 hour rest-periods between each training day. 3-min low intensity warm-up, and then exercise as rapidly as possible for 20 seconds, aiming to reach 85% of their maximum heart rate established during the submaximal cardiopulmonary exercise testing. Then followed by 40 seconds of low intensity exercise. Peanut group: Regular daily caloric intake estimated using data from 24hr recalls, the Miflin-St. Jeor equation, and stress/activity factors. Participants consume dry roasted, unsalted peanuts equivalent to approximately 10% of daily energy intake twice a day, range from approximately 2.4-3.6 ounces. Daily caloric intake will not differ from participants' typical diet. Participants are asked to bring back the empty, numbered peanut packets by the end of every week and will be given new packets weekly. Additionally, subjects will be informed that they will be randomly assessed weekly for compliance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intensity Interval Training | Other | Subjects will exercise according the the high intensity aerobic interval training regiment four times a week for four weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma Levels of Pro-inflammatory Cytokines (IL-6 and TNF-α) | cytokines (IL-6 and TNF-α) will be collected from blood samples | at study entry |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Richard p Sloan, PhD | CUMC/NYSPI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
data will be made available in June 2018
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Study terminated at early stage due to poor enrollment
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| ID | Title | Description |
|---|---|---|
| FG000 | High Intensity Interval Training First Then Peanut Consumption | Participants will engage in high intensity interval training first then peanut consumption High intensity interval training: 4 training sessions per week over a 4-week period, with 24hour rest-periods between each training day. Each session begins with a 3 min low intensity warm-up, and then participants exercise as rapidly as they can for 20 seconds, aiming to reach 85% of their maximum heart rate as established during the submaximal cardiopulmonary exercise testing. This 20 second period is followed by 40 seconds of low intensity exercise. |
| FG001 | Peanut Consumption First Then High Intensity Interval Training | Peanut consumption first then high intensity interval Training Peanut Consumption: Subjects will consume peanuts twice a day to replace 20% of their daily caloric intake for four weeks. Daily caloric intake will be estimated using data from 24hr recalls, the Miflin-St. Jeor equation, and stress/activity factors. Peanuts replaces protein and fat containing foods so that the daily caloric intake will not differ from diet. To assess compliance, participants will be asked to bring back the empty, numbered peanut packets by the end of every week and will be given new packets weekly. Subjects will be informed that they will be randomly assessed weekly for compliance; they will be asked to provide details of when and where they consumed their packets the previous day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Sequence (4 Weeks) |
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| Washout (4 Weeks) |
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| Second Sequence (4 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | High Intensity Interval Training First Then Peanut Consumption | High intensity interval training first then peanut consumption High intensity interval training: 4 training sessions per week over a 4-week period, with 24hour rest-periods between each training day. Each session begins with a 3 min low intensity warm-up, and then participants exercise as rapidly as they can for 20 seconds, aiming to reach 85% of their maximum heart rate as established during the submaximal cardiopulmonary exercise testing. This 20 second period is followed by 40 seconds of low intensity exercise. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Levels of Pro-inflammatory Cytokines (IL-6 and TNF-α) | cytokines (IL-6 and TNF-α) will be collected from blood samples | Study was terminated due to poor enrollment. No data was analyzed. | Posted | at study entry |
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Intensity Interval Training First Then Peanut Consumption | High intensity interval training first then peanut consumption High intensity interval training: 4 training sessions per week over a 4-week period, with 24hour rest-periods between each training day. Each session begins with a 3 min low intensity warm-up, and then participants exercise as rapidly as they can for 20 seconds, aiming to reach 85% of their maximum heart rate as established during the submaximal cardiopulmonary exercise testing. This 20 second period is followed by 40 seconds of low intensity exercise. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Sloan | Columbia University | 6467748947 | rps7@columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2018 | Mar 24, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 25, 2018 | Mar 24, 2020 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 11, 2018 | Mar 24, 2020 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
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Data collection staff is masked
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| Peanut Consumption | Other | Subjects will consume peanuts twice a day to replace 20% of their daily caloric intake for four weeks. |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Peanut Consumption First Then High Intensity Interval Training | Peanut consumption first then high intensity interval training Peanut Consumption: Subjects will consume peanuts twice a day to replace 20% of their daily caloric intake for four weeks. Daily caloric intake will be estimated using data from 24hr recalls, the Miflin-St. Jeor equation, and stress/activity factors. Peanuts replaces protein and fat containing foods so that the daily caloric intake will not differ from diet. To assess compliance, participants will be asked to bring back the empty, numbered peanut packets by the end of every week and will be given new packets weekly. Subjects will be informed that they will be randomly assessed weekly for compliance; they will be asked to provide details of when and where they consumed their packets the previous day. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Peanut Consumption | Regular daily caloric intake of each subject will be estimated using data from 24hr recalls, the Miflin-St. Jeor equation, and stress/activity factors. Participants will consume dry roasted, unsalted peanuts equivalent to approximately 10% of daily energy intake twice (total=20% total), which will range from 400kcal to 600 kcal, which corresponds to about 2.4 oz to 3.6 oz. Peanuts will replace protein and fat containing foods so that the daily caloric intake will not differ from participants' typical diet. To assess compliance, participants will be asked to bring back the empty, numbered peanut packets by the end of every week and will be given new packets weekly.Subjects will be informed that they will be randomly assessed weekly for compliance; they will be asked to provide details of when and where they consumed their packets the previous day. Peanut Consumption: Subjects will consume peanuts twice a day to replace 20% of their daily caloric intake for four weeks. |
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| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Peanut Consumption First Then High Intensity Interval Training | Peanut consumption first then high intensity interval Training Peanut Consumption: Subjects will consume peanuts twice a day to replace 20% of their daily caloric intake for four weeks. Daily caloric intake will be estimated using data from 24hr recalls, the Miflin-St. Jeor equation, and stress/activity factors. Peanuts replaces protein and fat containing foods so that the daily caloric intake will not differ from diet. To assess compliance, participants will be asked to bring back the empty, numbered peanut packets by the end of every week and will be given new packets weekly. Subjects will be informed that they will be randomly assessed weekly for compliance; they will be asked to provide details of when and where they consumed their packets the previous day. | 0 | 1 | 0 | 1 | 0 | 1 |
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| D055687 | Musculoskeletal and Neural Physiological Phenomena |