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

NCT ID: NCT03686982

Last Updated: 2018-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-04-30

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.

Conditions

Exercise Performance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Active Nitrate Bar

include dietary nitrate; L-citrulline; epicatechin; vitamin C and glutathione

Group Type: EXPERIMENTAL

Active Nitrate Bar

Intervention Type: OTHER

Bar containing Nitrate, L-citrulline; epicatechin; vitamin C and glutathione

Placebo Bar

Containing no active ingredients

Group Type: PLACEBO_COMPARATOR

Placebo Bar

Intervention Type: OTHER

No active ingredients

Interventions

Active Nitrate Bar

Bar containing Nitrate, L-citrulline; epicatechin; vitamin C and glutathione

Intervention Type: OTHER

Placebo Bar

No active ingredients

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PepsiCo Global R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andy Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Exeter, Sport and Health Sciences department

Locations

University of Exeter, Sport and Health Sciences department,

Exeter, , United Kingdom

Countries

United Kingdom

Other Identifiers

PEP-1706

Identifier Type: -

Identifier Source: org_study_id