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NCT03686982 Clinical Trial

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

Exercise Performance Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03686982
Other study ID # PEP-1706
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date April 30, 2018

Study information
Verified date September 2018
Source PepsiCo Global R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date April 30, 2018
Est. primary completion date April 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Active Nitrate Bar
Bar containing Nitrate, L-citrulline; epicatechin; vitamin C and glutathione
• Placebo Bar
No active ingredients

Locations
Country Name City State
United Kingdom University of Exeter, Sport and Health Sciences department, Exeter

Sponsors (1)
Lead Sponsor Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean power output during intermittent exercise test 5 days of intervention
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