Clinical trial NCT03631394: The Effects of Dietary Nitric Oxide and Anthocyanins on Anaerobic Exercise Performance
Official title: The Effects of Dietary Nitric Oxide and Anthocyanins on Anaerobic Exercise Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this graduate student research study is to investigate the effects of nitrate from beetroot powder with additional anthocyanins from tart cherry on exercise performance in healthy Loma Linda University students utilizing the Wingate Anaerobic test on stationary bike.

Detailed description: A randomized controlled double-blind crossover study with a baseline and two interventions. On day 1 (baseline), all subjects will have a lactate fingerstick measurement before and after the Wingate protocol. A random subsample (1/3 of subjects) will have 10 milliliters (2 teaspoon) of blood drawn for determination of serum allantoin. Subjects will then be equipped with a pulse oximeter and a heart rate monitor after which they will perform the Wingate Anaerobic test protocol. The protocol includes: 4 minutes of warm up, 3 seconds of warm up sprint with weights, 1-minute relaxed cycling, 2-minute rest, then 10 seconds cycling without weights. This will be followed by 30 seconds sprint with weights and end with 2 minutes of relaxed cycling. A post-activity blood draw will be performed for another 10 milliliters (2 teaspoon) of blood from the same one-third of subjects previously sampled. After baseline data collection, subjects will undergo a 1-week washout (avoiding high antioxidant foods) after which they will be randomized to treatment groups. On day 9, subjects will begin supplementation with nitrate from beetroot powder with additional anthocyanins, or nitrate from beetroot powder with a placebo for 7 days. On day 15 the subject will again repeat the same procedures as day 1, followed by another week of washout. They will supplement again on day 23 and repeat the same procedure as the first intervention on day 29.

Eligibility criteria: Inclusion Criteria:

* Healthy Loma Linda University students aged between 21 and 35 years old
* Willing to abstain from caffeine, mouthwash, chewing gums, and high antioxidant foods during the week of supplementation.

Exclusion Criteria:

* Diabetic
* having salivary gland disorder, cardiovascular disease or orthopedic injuries
* pregnant or breastfeeding
* taking NSAIDS
* have an allergy to anthocyanins and/or beetroot
* women who are on their menses

Primary outcomes:
measure: Change in blood lactate levels
timeFrame: Day 1
measure: Change in blood lactate levels
timeFrame: Day 15
measure: Change in blood lactate levels
timeFrame: Day 29
Secondary outcomes:
measure: Allantoin blood level
timeFrame: Baseline, day 15, and day 29
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Universtiy
state: California
Study officials:
affiliation: Loma Linda University
name: Edward Bitok, DrPH
role: PRINCIPAL_INVESTIGATOR
References: