Clinical Trials Logo

Clinical Trial Summary

Vigorous exercise can stress the body. Consuming special types of diet supplements may help the body recover better from exercise. This includes a bright red supplement called astaxanthin that is found in certain algae and causes the pink-red color in salmon. Astaxanthin is an antioxidant and may protect cells from damage and improve the way the immune system functions. The main purpose of this study is to determine if 4 weeks of consuming astaxanthin improves recovery from 2.25 hours of intensive running on a treadmill. This study will also measure whether or not astaxanthin supplementation improves skin health


Clinical Trial Description

RESEARCH PROCEDURES The research procedures will be conducted at the Human Performance Laboratory (Room 1201, Plants for Human Health Institute Building, 600 Laureate Way), operated by Appalachian State University at the North Carolina Research Campus (NCRC) in Kannapolis, NC. Subjects will come to the Human Performance Lab (HPL) for orientation/baseline testing with pre-supplementation blood sample collections, two 2.25 h running sessions, and additional lab visits to provide 1-day 7:00 am recovery blood samples) (thus 6 total performance lab visits). Skin health measurements will occur the morning before and during Performance Lab Visits #1, 2, 4, 5 (thus 8 total visits, with four of them occurring with HPL visits and four of them occurring separately). The total amount of time subjects will be asked to volunteer for this study is about 16 hours at the North Carolina Research Campus (over a 10-week period). Orientation/Baseline Testing (Performance Lab Visit #1) Four weeks prior to the first 2.25 h running session, subjects will report to the Human Performance Laboratory at approximately 7:00-8:30 am. Skin health measurements will be conducted the day before (following review of the consent form, with signing) and the day of baseline testing. Following the second skin health measurement, demographic and training histories will be acquired with questionnaires. A symptom inventory will be conducted using a 4-week retrospective questionnaire. Delayed onset of muscle soreness (DOMS) and the Profile of Mood States (POMS) will be assessed with standardized questionnaires. A blood sample will be collected in an overnight fasted state to coincide with the same time of the day for the post-supplementation blood draw. Body composition will be measured with the seca BIA and Bod Pod body composition analyzer (Life Measurement, Concord, CA). Study participants will be tested for maximal aerobic capacity (VO2max) during a graded, treadmill test with the Cosmed CPET metabolic device (Cosmed, Rome, Italy). Supplements for the 4-week supplementation period will be supplied in food supplement trays to facilitate compliance to the supplementation protocol. 3-day food records and the food list will be supplied with thorough instructions (for the 3-day period prior to the 2.25 hour treadmill running sessions). 4-Week Supplementation Periods Study participants will be randomized to astaxanthin and placebo groups, with supplements ingested daily (with the first meal) for 4-weeks prior to participation in the first 2.25 h running session. To assess potential adverse effects, a symptom inventory will be conducted using a 4-week retrospective questionnaire before and after the 4-week supplementation period. After a 2-week washout period, participants will repeat all procedures using the counterbalanced supplement. The astaxanthin and placebo supplements will look identical and be supplied by the sponsor. The astaxanthin capsule will contain 8 mg of astaxanthin from freshwater algae in starch beadlets, and the placebo capsules will contain just the starch beadlets with natural red coloring from the pitaya fruit. Four ounces of sockeye salmon contains about 4.5 milligrams of astaxanthin, with much higher levels in arctic shrimp and krill. Natural astaxanthin is sold around the world as a natural antioxidant supplement with a recommended dosage of 4 mg to 12 mg a day. LycoRed sources astaxanthin from Haematococcus pluvialis, a freshwater algae species of Chlorophyta from the family Haematococcaceae. This species is well known for its high content of the strong antioxidant astaxanthin, which is important in aquaculture, and cosmetics. 2.25 h Running Session (Performance Lab Visit #2, Skin Health Tests #3, #4) During the 3-day period prior to the 2.25 h running session, subjects will taper exercise training and ingest a moderate-carbohydrate diet using a food list restricting high fat foods, visible fats, and polyphenols. Subjects will record all food and beverage intake during the 3-day period, with macro- and micro-nutrient intake assessed using the Food Processor dietary analysis software system (ESHA Research, Salem, OR). Skin health measurements will be conducted the day before and the day of the running session (#3, #4) (overnight fasted state). Study participants will report to the Human Performance Lab in an overnight fasted state, take the skin health tests, provide a blood sample, ingest astaxanthin or the placebo supplement with water, then run 2.25 h at high intensity (70% VO2max) while ingesting water alone (3 ml/kg every 15 minutes). Blood samples will be collected at 0 h, 1.5 h, 3 h, and 21 h post-exercise. 2-WEEKS WASHOUT, CROSSOVER, REPEAT Subjects will engage in a 2-week washout period without supplements, crossover, and then repeat all procedures (Skin tests #4 through #8; Performance Lab visits #4,5,6). NOTE: Subjects randomized during the first trial to astaxanthin will have 6 weeks of washout when counting the 4-week placebo period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05409092
Study type Interventional
Source Appalachian State University
Contact
Status Completed
Phase N/A
Start date January 19, 2022
Completion date December 30, 2022

See also
  Status Clinical Trial Phase
Completed NCT04496154 - Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood N/A
Not yet recruiting NCT06434701 - Severe COVID-19 Infection in Children Presenting to EDs in Israel and England N/A
Enrolling by invitation NCT05020210 - Effect of Early Treatment With Sivelestat Sodium in ARDS Patients
Completed NCT04084301 - Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury N/A
Completed NCT04597983 - Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers in Amateur Cyclists N/A
Not yet recruiting NCT06016023 - Evaluation of Macrophage Inflammatory Protein-1α as a Periodontal Disease Biomarker
Not yet recruiting NCT05990933 - Role of Adrenaline in in the Inflammatory Response in Diabetes N/A
Not yet recruiting NCT04608643 - Inflammatory Markers and Cbc Indices in Severely Malnourished Children
Recruiting NCT01934049 - Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty Phase 4
Recruiting NCT01417923 - The Immune and Clinical Impacts of Vitamin D in Patients With Chronic Musculo-skeletal Pain Phase 4
Terminated NCT01377441 - Effect of Intravenous Ibuprofen on Inflammatory Responses in Patients Undergoing Surgery With General Anesthesia. Phase 4
Completed NCT01301079 - Evaluation of the Effect of Ketamine on Remifentanil-induced Hyperalgesia Phase 3
Terminated NCT00578578 - Trial to Study the Effects of Supplementary Omega-3 on Serum C-Reactive Protein Levels Phase 4
Recruiting NCT04611334 - The Effects of HRV Biofeedback on Chronic Kidney Disease Patient. N/A
Recruiting NCT03510702 - SCREENING OF EPIGENETIC BIOMARKERS (miRNAs) IN THE GINGIVAL SULCUS
Completed NCT03445234 - Blueberries, Bananas, Exercise Recovery N/A
Not yet recruiting NCT06450704 - Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disorders N/A
Not yet recruiting NCT05754294 - Electric Polarization of Red Blood Cells : A Cohort Study to Assess the Erythrocytes Membrane Integrity Through Charge Conservation, Following Cardiac Surgery.
Not yet recruiting NCT04386525 - Omega 3 and Ischemic Stroke; Fish Oil as an Option Phase 4
Completed NCT04864600 - CANDLE - A Study of Acute Health Effects of Exposure to Particles Generated by Candles N/A