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The Impact of Supplementation With Novel Prototype Nutrition Bar on Nitric Oxide Bioavailability and Measures of Athlete Performance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03686982
Recruitment Status : Completed
First Posted : September 27, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
PepsiCo Global R&D

Study Description
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Brief Summary:
Dietary nitrate, L-citrulline, epicatechin, vitamin C and glutathione have the potential to improve nitric oxide (NO) bioavailability, in humans, by influencing both the nitrate-nitrite-NO and NO synthase-dependent pathways, and the storage of NO. The study is designed to assess the efficacy of a newly developed product containing a mixture of these compounds. Specifically, the study will assess if the product is capable of increasing NO bioavailability and if this results in positive effects on exercise economy and intermittent exercise performance. These outcome measures have been chosen because they have previously been positively impacted by an increase in NO bioavailability.

Condition or disease Intervention/treatment Phase
Exercise Performance Other: Active Nitrate Bar Other: Placebo Bar Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Impact of Supplementation With Novel Prototype Nutrition Bar on Nitric Oxide Bioavailability and Measures of Athlete Performance
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : April 15, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Active Nitrate Bar
include dietary nitrate; L-citrulline; epicatechin; vitamin C and glutathione
 Other: Active Nitrate Bar
Bar containing Nitrate, L-citrulline; epicatechin; vitamin C and glutathione
Placebo Comparator: Placebo Bar
Containing no active ingredients
 Other: Placebo Bar
No active ingredients


Outcome Measures
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Primary Outcome Measures :
  1. Mean power output during intermittent exercise test [ Time Frame: 5 days of intervention ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and female participants in self-reported good general health as assessed by the standard procedures described below and specifically meeting the following blood pressure (BP) and body mass index (BMI) ranges: systolic BP: 100-140 mmHg; diastolic BP: 60-90 mmHg; and BMI 18.5-30.
  2. 18-40 years of age
  3. Physically active. Determined by meeting the following criteria: completes vigorous physical activity (i.e. activities that take hard physical effort and make you breathe much harder than normal; e.g. heavy lifting, digging, aerobics, fast cycling, running etc) at least 2 x per week and moderate physical activities (i.e. activities that take moderate physical effort and make you breath somewhat harder than normal; for example: carrying light loads, cycling at a regular pace, playing doubles tennis) at least 3 x per week.
  4. Understanding of the procedures to be undertaken as part of the study
  5. Willingness to participate in exercise testing and follow supplementation guidelines and other instructions provided by the experimenter
  6. Informed, voluntary, written consent to participate in the study

Exclusion Criteria:

  1. Known pulmonary, cardiovascular or metabolic disease
  2. Food allergies including phenylketonurea (PKU)
  3. Current regular use of any dietary supplement (excluding macronutrient based supplements) or previous use of any dietary supplement in the past 6 months that is known to have a lasting effect.
  4. Blood donation within 3 months prior to the start of the study
  5. Substance abuse within 2 years of the start of the study
  6. Smoking
  7. Any prescription and non-prescription medication which may impact saliva production (antidepressants, diuretics, analgesics, antihistamines, anti-hyper/hypo-tensives, anti-anxiety, appetite suppressants).
  8. Current or previous use of phosphodiesterase 5 (PDE5) inhibitors.
  9. Participation in another clinical trial within past 4 weeks.
  10. Participation in another PepsiCo study within the past 6 months.
  11. Highly trained or elite endurance athlete as determined by current or recent (within 3 months) participation in an endurance sport at international or national level.
  12. Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686982


Locations
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United Kingdom
University of Exeter, Sport and Health Sciences department,
Exeter, United Kingdom
Sponsors and Collaborators
PepsiCo Global R&D
Investigators
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Principal Investigator: Andy Jones, PhD University of Exeter, Sport and Health Sciences department
More Information
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Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT03686982    
Other Study ID Numbers: PEP-1706
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No