Effect of Milled Chia Seed (Mila) on Performance in Endurance Athletes

Consent to Participate in Research

TITLE OF RESEARCH PROJECT:

Effect of milled chia seed (Mila) on performance in endurance athletes

Principal Investigator: David C. Nieman

Department: Human Performance Laboratory at the North Carolina Research Campus, Appalachian State University, Health, Leisure, Exercise Science

Contact Information: David C. Nieman, DrPH, FACSM, 828-773-0056, ; Director of the Human Performance Lab at the NCRC and Professor, Appalachian State University

What is the purpose of this research?

Chia seed is an oilseed native to southern Mexico and northern Guatemala, and was once a major food source for the Aztecs. Chia seed has 4.4 grams of omega-3 fats per 25 gram serving. This makes chia seed one of the richest plant sources for omega-3 fats. Chia seed is also high in antioxidants, calcium, and fiber.

Chia means "strength" in the language of the Aztecs, and was considered running food because messengers could run all day while ingesting chia seeds.

No one has yet tested the influence of increased intake of omega-3 fats from milled chia seed on endurance performance. This study (using a randomized, crossover design) will determine if the omega-3 fats from milled chia seed (25 grams/day) over a 2-week period improves endurance performance.

Why am I being invited to take part in this research?

You will be one of 20 male cyclists in this study. You are being invited to take part in this research if you are between the ages of 18 to 45 years, healthy with no known diseases (heart disease, cancer, stroke, arthritis, diabetes), non-obese (body mass index or BMI must be below 30 kg/m2), non-smoker, currently training for and competing in road races (category 1 to 5), and capable of cycling for 2 hours at a high intensity on your own bicycles with CompuTrainers in a laboratory setting. You must agree to stay weight stable, train normally, and avoid intake of fish and sea food, fish oil, flaxseed oil, large dose vitamin/mineral supplements, herbs, and medications (to control health problems) starting one week before the study begins and throughout the 4-week study period. You must also agree to limit intake of sunflower, safflower, soybean, corn oil, canola oil, and similar plant oils (olive oil is preferred during the study, in moderation). You must also not be at risk for heart disease or currently experiencing heart disease related symptoms, as verified with a screening questionnaire. You agree prior to baseline testing at the ASU-NCRC Human Performance Lab to review the consent form, discuss study requirements, and consider providing written consent. If you sign the consent form, you will fill in a screening questionnaire to verify that you are at low risk for heart disease.

Are there reasons I should not take part in this research?

I understand that I should not volunteer for this study if I am a smoker, obese, under the age of 18 or over the age of 45 years, not healthy because of a chronic disease such as heart disease, cancer, stroke, arthritis, or diabetes, on any type of medication or nutritional supplement to control a health problem, incapable of cycling for 2 hours at a high intensity, or unwilling to follow the diet restrictions during the study (as outlined in the previous section).

What will I be asked to do?

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. You will need to come here four times during the study (orientation/baseline testing, pre-study blood draw, and two 2-hour cycling bouts). The total amount of time you will be asked to volunteer for this study is about 9 hours at the Human Performance Laboratory.

Milled Chia Seed Supplement: In this randomized crossover, you will be randomized to milled chia seed (Mila) or no chia seed for the first 2-week period, and then crossed over to the opposite group during the second 2-week period. (See Figure). Subjects on chia will consume milled chia seed on the day of the 2-h cycling test. During the chia seed supplementation phase, you will ingest 25 mg/day of the milled chia seed supplement (Mila) (in fruit juice or other beverages, yogurt, breakfast cereal, rice/vegetable dishes, etc.). Chia seed will be divided and consumed with each of 3 meals per day during the study. If for any reason you miss a day, increase intake over the next two days to catch up. If you miss 3 or more days in a row of consuming the milled chia seed, you will be asked to leave the study. During the 2-week period without chia seed, you will eat normally. During both the chia seed and no chia seed 2-week periods (and starting one week before the study), you will avoid omega-3 fats from fish, sea food, fish oil, flaxseed, and flaxseed oil. You will also avoid other nutritional and herbal supplements.

Orientation/Baseline Testing: One week prior to the study, you will report to the NCRC Human Performance Lab at 2:30 pm for orientation, to review and provide consent for study participation, to fill in the exercise screening questionnaire, and for baseline fitness and body fat testing. You will be tested for VO2max on Lode cycle ergometers and for body composition using the Bod Pod system. During the VO2max test, you will cycle with a facemask to measure oxygen consumption against increasing resistance until you can no longer continue due to exhaustion. For the BodPod test, you will sit in a special box with a tight fitting swim suit for about 10 minutes while resting quietly. After baseline testing, for five continuous weeks of the study, you will be on an omega-3 restricted diet (i.e., no fish food, seafood, flaxseed), and will avoid nutritional and herbal supplements.

First Blood Sample: One week after baseline testing, you will return to the ASU-NCRC Human Performance Lab around 2:30 pm to provide a 14 ml blood sample (about one tablespoon) from a vein in your arm or hand and to receive the milled chia seed supplement (half the group).

Test Day Diet Instructions: After 2-weeks of milled chia seed ingestion (or no chia seed) (during which you maintain normal training patterns), 14 ml-blood samples from a vein in your arm or hand will again be collected (same day/time of the week, 2:30 pm). Prior to the test session, you will consume a standardized meal at 12:00 noon using a carbohydrate-protein beverage (Gatorade protein recovery drink, http://www.gatorade.com/default.aspx#product?s=recover) at 10 kcal/kg with 10 grams milled chia seed (or none) mixed in. Extra carbohydrate-protein beverage will be given to subjects not on chia seed to equal the energy ingested from chia seed. About 15 mg milled chia seed (or none) will also be consumed during breakfast that day.

2-Hour Cycling Session: After the blood draw, you will cycle on your own bicycles on CompuTrainers for 2 hours (3:00-5:00 pm) at 60% of maximal Watts output, with a 15-km time trial inserted after 1.75-h cycling. During the 15-km time trial, you will cycle 15-km as fast as possible. During the 2-hour cycling bout, heart rate and rating of perceived exertion (RPE) will be monitored every 30 minutes, with continuous monitoring of power output (Watts).

Post-Exercise Blood Samples: Blood samples will be taken again from a vein in your arm or hand immediately following exercise (5 pm), and then 1-h post-exercise (6 pm). Thus 3 blood samples will be collected before and after exercise, with approximately 14 ml collected each draw for a total of 42 ml (about 3 tablespoons).

Crossover and Second Cycling Test: Following the first 2-h cycling test, you will switch over to the opposite group and consume chia seed (or no chia seed) for two weeks. You will return to the lab (same time and day of the week) to repeat the 2-h cycling test. Three additional blood samples will be collected after the second phase (thus a total of 7 samples x 14 ml = 98 ml drawn during the entire study) (about 6.5 tablespoons). Blood samples will be analyzed for omega-3 fats, especially the unique fat found in milled chia seed.

What are possible harms or discomforts that I might experience during the research?

You are a healthy athlete and accustomed to vigorous and prolonged exercise. Thus the risk of heart or other medical problems when cycling two hours in a Human Performance Laboratory is very low for you. Ingestion of milled chia seed has no known side effects.

The risks of collecting a blood sample from a vein in your arm or hand include the possibility of requiring more than one attempt to obtain the blood sample, local discomfort (pinch when the needle enters your skin), minor bruising or bleeding at the site (10%), or possible temporary lightheadedness, infection (<0.01%), or development of a blood clot (< 0.01%). There are two 14-day periods in this study, with four blood samples collected in the first phase, and three in the second phase. The total amount of blood being withdrawn (about 6.5 tablespoons) will not affect your ability to participate in normal daily activities. A trained and experienced individual will perform the technique and your blood will be collected in a hygienic setting with sterile materials and biohazard protection measures to minimize these risks. In the rare case of exposure of your blood or tissue to research personnel, we will analyze your blood for HIV and hepatitis (a positive HIV or hepatitis test will be reported to you).

What are possible benefits of this research?

There may be no personal benefit from your participation but the information gained by doing this research may help others in the future. Milled chia seed is a nutritious food product that may improve endurance performance (as tested in this study).

Will I be paid for taking part in the research?

We will pay you $300 for the time you volunteer while being in this study. If you do not complete the study, compensation will be pro-rated according to the percentage of study requirements completed. For example, if you complete the first half of the study, but then drop out of the study, you will receive $150. Current University policy requires the collection of Social Security numbers (or Appalachian Banner ID numbers) if study compensation is more than $20 for a single study or $599 for participation in multiple studies in a calendar year. Since the compensation for this study is more than $20, you will need to provide your address and Social Security number (or Appalachian Banner ID number) when you complete the form for payment.

How will you keep my private information confidential?

Your information will be combined with information from other people taking part in the study. When we write up the study to share it with other researchers, we will write about the combined information. You will not be identified in any published or presented materials. To ensure that your information is kept confidential, identification numbers but not names will be used on all documents. All data entry and analysis will be conducted with statistical programs using coded identification. Your files will be stored in the research manager’s office under lock and key and identifiable information will be deleted after two years. All blood samples will be coded with identification numbers only, and samples that remain after all analysis in this study has been completed will be destroyed within two years of collection. With your permission, photos may be taken during the study and used in scientific presentations of the research findings. Your identity will not be revealed when the photos are presented. Please indicate whether or not you agree to having your photo taken for use in scientific presentations (without name identification):

⧠ Yes, I grant permission for my photo to be taken and used in scientific presentations

⧠ No, I do not grant permission

What if I get sick or hurt while participating in this research study?

If you need emergency care while you are at the research site, it will be provided to you. If you believe you have been hurt or if you get sick because of something that is done during the study, you should call your doctor or if it is an emergency call 911 for help. In this case, tell the doctors, the hospital or emergency room staff that you are taking part in a research study and the name of the Principal Investigator. If possible, take a copy of this consent form with you when you go. Call the Principal Investigator (Dr. David Nieman, 828-773-0056) as soon as you can (he needs to know that you are hurt or ill). Costs associated with this care will be billed in the ordinary manner, to you or your insurance company. However, some insurance companies will not pay bills that are related to research costs. You should check with your insurance about this. Medical costs that result from research-related harm may also not qualify for payments through Medicare, or Medicaid. You should talk to the Principal Investigator about this, if you have concerns.

Who can I contact if I have a question?

The people conducting this study will be available to answer any questions concerning this research, now or in the future. You may contact the Principal Investigator at 828-773-0056. If you have questions about your rights as someone taking part in research, contact the Appalachian Institutional Review Board Administrator at 828-262-2130 (days), through email at or at Appalachian State University, Office of Research and Sponsored Programs, IRB Administrator, Boone, NC 28608.