Q & A

What you can expect from participating in the Algae Nutritional Research Study

Who is conducting the study, why you have been asked to participate, how you were selected, and what is the approximate number of participants in the study?

The Mayfield Lab at UC San Diego is conducting a research study to better understand how dietary consumption of natural green algae impacts human gut health. You have volunteered for this study given your compatibility with one of three cohorts that will comprise the study - student-athletes, individuals with normal gut health, and individuals with prior history of experiencing IBS-like symptoms. It is anticipated that there will be approximately 50 participants in each cohort. Participants will consume a small serving (1 to 3 grams) of algae powder daily for 30 days. 

Why is the study being done?

The purpose of this study is to assess the impacts on gut health of people who consume the wild-type green algae, Chlamydomonas reinhardtii. Multiple animal trials have shown a positive impact on gut health and digestive function, and this study will help to establish a baseline of responses to consumption of this algae in humans. There is also the potential that new scientific findings may be generated by this study that impact our views on gut health and the role of algae in impacting gut health. 

What will happen to you in this study?

You will receive a small bottle of dried algae along with instruction on how to measure the appropriate amount for consumption. You will also receive a kit that will allow you to collect a small stool sample from toilet paper, as well as instructions and a mailing pouch to send the sample in. Prior to starting the study, you will be asked to complete a questionnaire regarding diet and lifestyle; you will also be asked to provide a small microbiome (stool) sample on three occasions - before you begin consuming the algae, seven days into the study, and at the end of the study. Some, but not all, participants will have their microbiome determined at the end of the study.

How do I sign up for this study?

On the home page that got you to this form is a button that will take you to a sign up page. On that page you will need to provide your name, email address, age, sex, and answer a few simple questions about your digestive health. Once we receive your application you will be contacted with a questionnaire and an additional link to the American Gut Project, which you will also need to sign up on, as AGP is responsible for collecting your stool sample and determining your microbiome. There is no charge to you for signing up on AGP, those costs are covered by this project. 

How are stool samples collected?

Stool samples will be collected from used toilet paper using sterile swabs following the instructions outlined by the American Gut Project. You will receive detailed instructions in your American Gut kit. You may also visit americangut.org/howitworks for more information on sample collection.

How long will the study last, and what is your total time commitment?

The consumption phase of the study will run for 30 days; you will be able to consume the algae at any time during the day, either with a meal or at other times, although we would ask that you be consistent in terms of consuming the required amount of algae every day. The amount of time this should involve is minimal; again, you will also be asked to provide microbiome/stool samples on three separate occasions as part of the study. 

What risks are associated with this study?

The wild-type algae in question has been used in mice trials and pig trials with no signs of adverse effect; in fact, this wild-type algae has shown a correlation with positive gut health. While no potential adverse effects are known, or anticipated, it is possible that an individual participant could have an adverse or allergic response to the algae, and some risks are unknown. 

Will there be a placebo control group in this study?

All scientific studies benefit from having control groups. For this study there will be one (placebo) control group that will receive a dried wheat grass powder, instead of the dried algae powder. You could potentially be placed into this placebo group. 

What are the alternatives to participating in this study?

The study is entirely voluntary and not participating will have no consequence. There is no alternative study.

What benefits can be reasonably expected?

The wild-type algae being consumed has been shown to improve gut health in both mice and pigs, and this study is intended to address if this is observed in humans as well. However, there may or may not be benefit for subjects that receive algae, and none for the placebo control. There is also the benefit of generating new scientific knowledge that can help advance our understanding of the impact of food on gut health and the gut microbiome. 

Can I choose to not participate or withdraw from the study without penalty?

Of course. Participation in research is entirely voluntary. You may refuse to participate or withdraw at any time without penalty. If you decide that you no longer wish to continue your participation in the study, you will be requested to contact the Mayfield Lab to advise of your intent to withdraw. You will still be informed of the results of the study, should you request this.

Can I participate in the study if I am pregnant?

No, pregnant women cannot participate in this study. We do not have reason to believe that there is any significant risk to pregnant women or their unborn child. However, this is the first time that this specific algae has been consumed by humans, and therefore there may be some risks in consuming this algae that cannot be known at this point, therefore pregnant women are excluded from this trial.

Can I be withdrawn from the study without your consent?

You may be withdrawn from the study if you do not complete the consent form. You may also be withdrawn from the study if you do not follow the instructions given you by the study personnel. There is also the chance that the study is over subscribed, and therefore not everyone that applies may be accepted into the study.

Will I be compensated for participating in this study?

You will not be financially compensated in this study.

Are there any costs associated with participating in this study?

There are no costs associated with participating in this study.

What if I am injured as a direct result of being in this study?

If you are injured as a direct result of participation in this research, the University of California will provide any medical care you need to treat those injuries. The University will not provide any other form of compensation to you if you are injured. You may call the Human Research Protections Program Office at 858-246-HRPP (858-246-4777) for more information about this, to inquire about your rights as a research subject or to report research-related problems. 

What about my confidentiality?

Your research records will be kept confidential to the fullest extent allowed by law.

However unlikely or outside the scope of this study, we are required by law to report information about known or reasonably suspected incidents of abuse or neglect of a child, dependent adult or elder including physical, sexual, emotional, and financial abuse or neglect. If any investigator has or is given such information, he or she will report such information to the appropriate authorities. Your identity under the American Gut Project is barcoded, and this barcode will be shared with researchers associated with this study. 

Who can I contact if I have questions?

If you have questions regarding the study or related research matters, please contact Dr. Steve Mayfield (smayfield@ucsd.edu) or 858-822-7743 or the American Gut Project (Embriette Hyde, ehyde@ucsd.edu).