Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531070
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Nitrate Formulations and Exercise Performance
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Different Nitrate Formulations on Strength and Endurance Performance in Recreationally Trained Adults
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
this study compares the acute effects of Nitrate and Nitrate plus citrulline supplementation on physical performance in recreationally trained males and females This is a cross-over within-participant comparison design concluding three arms i 600 mg of Nitrate N ii 600 mg Nitrate and Citrulline NC and iii Placebo PL
Conditions N NC and PL will be tested one week apart considering a minimum washout period of 72 hours
Dependent variables
Number of completed repetitions to failure in squat using 75 of 1RM
Ventilatory thresholds VT1 and VT2 and Vo2 max from a progressive to exhaustion running test PGT
Lactate post within 1 min of having completed the PGT
Rating of perceived exertion RPE by the Borg 6-to-20-point scale recorded every 2 min and at the end of the PGT
Heart rate associated with VT1 VT2 and Vo2max - Heart rate maximum
Maximal aerobic speed MAS calculated from the average speed of the last 2 minutes of the PGT
time limit test at MAS conducted after 15 min of having completed the PGT
Conditions N NC and PL will be tested one week apart considering a minimum washout period of 72 hours
Dependent variables
Number of completed repetitions to failure in squat using 75 of 1RM
Ventilatory thresholds VT1 and VT2 and Vo2 max from a progressive to exhaustion running test PGT
Lactate post within 1 min of having completed the PGT
Rating of perceived exertion RPE by the Borg 6-to-20-point scale recorded every 2 min and at the end of the PGT
Heart rate associated with VT1 VT2 and Vo2max - Heart rate maximum
Maximal aerobic speed MAS calculated from the average speed of the last 2 minutes of the PGT
time limit test at MAS conducted after 15 min of having completed the PGT
Detailed Description:
Aim
To analyse and compare the acute effect of two different nitrate formulations on strength and endurance performance in young recreationally trained individuals In a cross-over within-participant comparison design the participants will be assigned either to ingest i 600 mg of Nitrate N ii 600 mg Nitrate and Citrulline NC and iii Placebo PL
Design Cross-over randomised controlled within participant design including one group undertaking three different treatment conditions
1 Nitrate N providing 600 mg 96 mmol of Nitrate NO-3
2 Nitrate Citrulline NC providing 600 mg 96 mmol of Nitrate NO-3 and 6 g of citrulline-malate
3 Placebo PLA Participants 15 or higher Inclusion criteria a males and females 18-40 years of age b physically active participants with experience in resistance training performing squat and endurance running as habitual exercises c free from musculoskeletal limitations or injuries d agree not to ingest any other supplement during the study
Exclusion criteria a a history of various metabolic conditions or diseases b use of a variety of medications including but not limited to those with androgenic andor anabolic effects andor nutritional supplements known to affect training outcomes such as creatine proteins etc within 6 weeks before the beginning of the study c current use of tobacco products
All participants must provide written informed consent by the Declaration of Helsinki The University ethics committee must approve procedures before starting with the data collection
Procedures Day 0 Familiarization with the testing procedures including the progressive test to determine the 1RM value in Squat
Diet Record Each participant will complete a 1-week diet record using a food frequency questionnaire FFQ This questionnaire consists of questions relating to the weekly consumption of different types of food to estimate energy consumption and the nutritional composition of the reported diets Participants were instructed to maintain their habitual diet throughout the study If any change in diet patterns is identified the participants were dropped from the study
Supplementation protocol
Days 1 to 3 Supplements N NC or PLA will be ingested 2 hr before a standard low-volume training session including 3 sets of 8 to 10 reps of squat and deadlift using a very light load eg own body mass and flexibility exercises following by 5 min of running at self-paced intensity rated as light RPE 12 This routine can be completed at home
Day 4 supplements will be ingested 25 hours before the assessments
The three conditions Nitrate N Nitrate Citrulline NC and Placebo PL will be tested one week apart considering a minimum washout period of 72 hours a strategy that has previously been used in studies with a similar design
All participants will be following an identical training week in each of the three treatment conditions
Dependent variables
o Number of completed repetitions in a singular set to failure in a squat with 75 of 1RM
Lactate Post within 1 min of having completed the squat 15 min rest Progressive to exhaustion on a treadmill PGT
Ventilatory thresholds VT1 and VT2
Vo2 max
Lactate post within 1 min of having completed the PGT
Rating of perceived exertion RPE using the Borg 6-to-20-point scale recorded every 2 min and at the end of the PGT
Heart rate associated with VT1 VT2 and Vo2max - Heart rate maximum
Maximal aerobic speed MAS calculated from the average speed of the last 2 minutes of the PGT
15 min rest
Maximal Aerobic Speed test no cortex
Lactate pre 15 min post PGT
The participants should run until exhaustion at the previously determined MAS eg 198 kmh
RPE after 1 minute and at the end
Heart rate every 1 minute and at the end
Lactate post within 1 minute of having completed the test
To analyse and compare the acute effect of two different nitrate formulations on strength and endurance performance in young recreationally trained individuals In a cross-over within-participant comparison design the participants will be assigned either to ingest i 600 mg of Nitrate N ii 600 mg Nitrate and Citrulline NC and iii Placebo PL
Design Cross-over randomised controlled within participant design including one group undertaking three different treatment conditions
1 Nitrate N providing 600 mg 96 mmol of Nitrate NO-3
2 Nitrate Citrulline NC providing 600 mg 96 mmol of Nitrate NO-3 and 6 g of citrulline-malate
3 Placebo PLA Participants 15 or higher Inclusion criteria a males and females 18-40 years of age b physically active participants with experience in resistance training performing squat and endurance running as habitual exercises c free from musculoskeletal limitations or injuries d agree not to ingest any other supplement during the study
Exclusion criteria a a history of various metabolic conditions or diseases b use of a variety of medications including but not limited to those with androgenic andor anabolic effects andor nutritional supplements known to affect training outcomes such as creatine proteins etc within 6 weeks before the beginning of the study c current use of tobacco products
All participants must provide written informed consent by the Declaration of Helsinki The University ethics committee must approve procedures before starting with the data collection
Procedures Day 0 Familiarization with the testing procedures including the progressive test to determine the 1RM value in Squat
Diet Record Each participant will complete a 1-week diet record using a food frequency questionnaire FFQ This questionnaire consists of questions relating to the weekly consumption of different types of food to estimate energy consumption and the nutritional composition of the reported diets Participants were instructed to maintain their habitual diet throughout the study If any change in diet patterns is identified the participants were dropped from the study
Supplementation protocol
Days 1 to 3 Supplements N NC or PLA will be ingested 2 hr before a standard low-volume training session including 3 sets of 8 to 10 reps of squat and deadlift using a very light load eg own body mass and flexibility exercises following by 5 min of running at self-paced intensity rated as light RPE 12 This routine can be completed at home
Day 4 supplements will be ingested 25 hours before the assessments
The three conditions Nitrate N Nitrate Citrulline NC and Placebo PL will be tested one week apart considering a minimum washout period of 72 hours a strategy that has previously been used in studies with a similar design
All participants will be following an identical training week in each of the three treatment conditions
Dependent variables
o Number of completed repetitions in a singular set to failure in a squat with 75 of 1RM
Lactate Post within 1 min of having completed the squat 15 min rest Progressive to exhaustion on a treadmill PGT
Ventilatory thresholds VT1 and VT2
Vo2 max
Lactate post within 1 min of having completed the PGT
Rating of perceived exertion RPE using the Borg 6-to-20-point scale recorded every 2 min and at the end of the PGT
Heart rate associated with VT1 VT2 and Vo2max - Heart rate maximum
Maximal aerobic speed MAS calculated from the average speed of the last 2 minutes of the PGT
15 min rest
Maximal Aerobic Speed test no cortex
Lactate pre 15 min post PGT
The participants should run until exhaustion at the previously determined MAS eg 198 kmh
RPE after 1 minute and at the end
Heart rate every 1 minute and at the end
Lactate post within 1 minute of having completed the test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None