Trial Outcomes & Findings for The Anti-Inflammatory Effects of Exercise and Peanut Consumption (NCT NCT03212144)
NCT ID: NCT03212144
Last Updated: 2020-04-06
Results Overview
cytokines (IL-6 and TNF-α) will be collected from blood samples
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
at study entry
Results posted on
2020-04-06
Participant Flow
Study terminated at early stage due to poor enrollment
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First Sequence (4 Weeks)
STARTED
|
2
|
1
|
|
First Sequence (4 Weeks)
COMPLETED
|
1
|
1
|
|
First Sequence (4 Weeks)
NOT COMPLETED
|
1
|
0
|
|
Washout (4 Weeks)
STARTED
|
1
|
1
|
|
Washout (4 Weeks)
COMPLETED
|
1
|
1
|
|
Washout (4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Sequence (4 Weeks)
STARTED
|
1
|
1
|
|
Second Sequence (4 Weeks)
COMPLETED
|
0
|
0
|
|
Second Sequence (4 Weeks)
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
First Sequence (4 Weeks)
Lost to Follow-up
|
1
|
0
|
|
Second Sequence (4 Weeks)
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
The Anti-Inflammatory Effects of Exercise and Peanut Consumption
Baseline characteristics by cohort
| Measure |
High Intensity Interval Training First Then Peanut Consumption
n=2 Participants
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.
|
Peanut Consumption First Then High Intensity Interval Training
n=1 Participants
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.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 0 • n=99 Participants
|
25 years
STANDARD_DEVIATION 0 • n=107 Participants
|
31.5 years
STANDARD_DEVIATION 5.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at study entryPopulation: Study was terminated due to poor enrollment. No data was analyzed.
cytokines (IL-6 and TNF-α) will be collected from blood samples
Outcome measures
Outcome data not reported
Adverse Events
High Intensity Interval Training First Then Peanut Consumption
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Peanut Consumption First Then High Intensity Interval Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place