Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05184855 |
| Other study ID # |
20-0213 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2021 |
| Est. completion date |
August 15, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
Appalachian State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to determine if 2-weeks supplementation with blueberries (1
cup/day) compared to placebo can mitigate muscle soreness and damage, and improve
inflammation resolution and metabolic recovery during a 5-day period after engaging in an
acute, 90-minute bout of eccentric exercise. The primary outcome will be plasma oxylipin
levels, extending previously collected data showing that blueberry ingestion decreases
post-exercise oxylipins generated from cytochrome P450 enzymes.
Description:
Participants will be randomized to the blueberry or placebo groups. The parallel group design
is being utilized in this study because of the "repeat exercise bout" effect (i.e.,
post-exercise muscle damage and inflammation are reduced when the same bout is repeated
within days and weeks of the first bout). Participants will come to the lab at 7:00 am at the
beginning of the 2-week supplementation period, and then Monday (eccentric exercise bout) and
Tuesday through Friday (recovery) in an overnight fasted state. Seven blood samples will be
collected and analyzed for various measures of muscle damage, oxylipins, and inflammation.
After each of the blood draws, participants will provide a muscle soreness rating (DOMS).
Three 24 h urine samples will be collected and analyzed for key metabolic markers of
blueberry ingestion.
Visit #1 Pre-Study Study participants will come to the performance lab for orientation to
study procedures. This will include a review of the consent form, completion of basic
questionnaires, and an introduction to the eccentric muscle exercise bout and the
strength/power performance testing protocol (about 1.5 hours) (visit #1). During visit #1,
participants will be given two 3-day food records with thorough written and oral instructions
on recording procedures (with food models). The 3-day food records will be completed on a
Thursday, Friday, and Saturday sequence prior to visits #2 and #3. During visit #1,
participants will be given three 24 h urine collection bottles with thorough written and oral
instruction on collection procedures. The 24 h urine collection bottles will be collected on
the day before visits #2, #3, and #7.
This will be followed by another lab session for pre-study measurements and sample collection
(visit #2). Participants will be randomized to blueberry or placebo groups, and provided a
2-weeks supply of supplements. Participants in the blueberry and placebo groups will consume
26 g/d powder mixed in water each day in split doses (half in the morning, half in the
afternoon). Compliance will be checked weekly through email correspondence from the Research
Manager. A 3-day food record will be collected at the beginning and end of the 2-week
supplementation period to assess the background diet. The 3-day food record will be turned in
and reviewed by the research team, and analyzed for nutrient and flavonoid content using the
Food Processor Version 11.1 (ESHA Research, Salem, OR, USA). ESHA's port utility (Version
4.0; ESHA Research, Salem, OR, USA) will be used to upload the Flavonoid Values for USDA
Survey Foods and Beverages (FNDDS) 2007-2010 database. Food/beverage intake will be assessed
for macro- and micro-nutrients, total flavonoids and subtotals for each of the six flavonoid
subclasses, and three individual flavonoid values (quercetin, cyanidin, and epigallocatechin
gallate (EGCG)).
The study will include 5 other lab visits during a one-week period starting on a Monday
(visit #3), with morning visits at 7:00 am on Tuesday through Friday (visits 4-7). At each of
the 7 lab visits, study participants will come to the lab at 7:00 am not having consumed food
or beverages (other than water) for at least the previous 9 hours, and having abstained from
vigorous exercise for at least the previous 24-48 hours. The Monday session will take about
2.5 hours (7:00 to 9:30 am), and the Tuesday through Friday sessions will take about 30-45
minutes each. The total amount of time participants will be asked to volunteer for this study
is about 8-9 hours at the performance lab.
Baseline Testing (Visit #2) Participants will come to the lab at 7:00 am in an overnight
fasted state dressed in exercise clothes. Participants will provide a blood sample using
standard phlebotomy procedures. Participants will turn in their 24 h urine collection bottle
and 3-day food record. Height, body weight, and body composition will be measured in a
private section of the lab. Bioelectrical impedance (BIA) using the seca BIA scale will be
used to assess body composition (i.e., the percent of body weight that is fat tissue) and
body weight. Participants will remove shoes and socks and stand with bare feet on the seca
scale for about 7-10 seconds while using the hands to grasp the side rails. Percent body fat
will also be measured using the BodPod. Participants will sit inside the BodPod with a
tight-fitting swim suit for about 10 minutes while body fat is calculated. Delayed onset of
muscle soreness (DOMS) will be assessed using a 1-10 scale.
Participants will perform some light exercises to warm up, followed by five muscle function
tests: vertical jump, bench press, leg-back strength, anaerobic power through the 30-second
Wingate test, and 60-yard shuttle run.
1. Vertical jump: Participants will first stand erect with the feet flat on the floor and
reach as high as possible with both arms and hands (standing reach height). Participants
will then squat down and jump as high as possible with one arm and hand, and tap the
measuring device on the Vertec vertical jump apparatus (jump height). This will be
repeated three times, with the best score recorded as the difference between the jump
and standing reach heights.
2. Bench press to exhaustion at 50%/75%: Participants will lie down supine on a bench, and
with spotters standing on either side attempt to bench press a weighted bar equal to 75%
(males) or 50% (females) body weight as many times as possible (to a metronome set at 60
beats/min or 30 lifts/min). The bar must touch a foam block on the chest lightly in the
down position, and the arms must be straight in the up position.
3. Leg-Back Strength: Leg/lower back strength will be assessed with a dynamometer. With the
legs slightly bent at the knee, participants will grasp a bar attached via a chain and a
force measuring device with straight arms, and then lift up with maximal effort for
several seconds. This will measure the isometric strength of both legs and back, and
will be repeated three times.
4. 30-Second Wingate Cycling Test, Anaerobic Power: The Lode cycle ergometer will be
adjusted to the participant's body weight (7 watts per kilogram). After a warm up,
participants will sprint cycle at maximal speed for 30 seconds. The peak power and
average power will be recorded and adjusted to body weight.
5. 60-Yard Shuttle Run Test: The shuttle run is a test of speed and agility. Participants
will run back and forth to 5 yards, 10 yards, and 15 yards, for a total of 60 yards.
Participants are required to touch the line with their hand at each turn, and run
through the finish line. The test involves five touches. The time to complete the test
in seconds is recorded. The score is the best time of three trials.
Testing Sequence, Day of Eccentric Muscle Exercise (Monday, Visit #3) and 4-Days Recovery
(Tuesday through Friday) (Visits #4-7):
Participants will come to the lab at 7:00 am in an overnight fasted state (i.e., no food or
beverages other than water for at least the previous 9 hours). Participants will turn in
their 24 h urine collection bottle and 3-day food record. Participants will be weighed and
then provide a blood sample, and give a DOMS rating. The blueberry or placebo supplements
(half dose) will be consumed mixed in water. Participants will perform some light exercises
to warm up, followed by five muscle function tests: vertical jump, bench press, leg-back
strength, anaerobic power through the 30-second Wingate test, and shuttle run. Participants
will take these performance tests before and after the 90-minute eccentric muscle exercise
bout, and each of the following four mornings at the performance lab.
After taking the five performance tests, participants will engage in 90-minutes of eccentric
exercise. Immediately following exercise, participants will provide a muscle soreness rating
and a blood sample. Participants will then take the five muscle function tests. Participants
will ingest the supplements (half dose) during the afternoon (3-6 pm). Participants will
return at 7:00 am in an overnight fasted state four days in a row (Tuesday through Friday)
after Monday's eccentric exercise bout, and provide DOMS ratings, and blood samples followed
by ingestion of the supplements (half dose). Following ingestion of the supplements,
participants will take the five muscle function tests. Participants will consume the second
half dose of the supplements in the afternoon (Tuesday, Wednesday, Thursday). On Friday
morning, participants will provide blood, turn in their 24 h urine sample, and take the
supplement (half dose) prior to the muscle function tests. During this week of testing,
participants will engage in normal training.
