DESCRIPTION:
Thank you for your interest in the Keto-Med Trial, which will investigate the effects of a Well-Formulated Ketogenic Diet versus a Mediterranean-Plus Diet in individuals with type 2 diabetes and prediabetes on glycemic control, body weight, cardiovascular risk factors, immune function and inflammatory markers, and the gut microbiome. In order to find out whether you are eligible and interested in participating, you will be asked to complete a screening questionnaire.
There are three steps involved in this screening process: 1) read a brief overview of the main study 2) consent to be screened via the online questionnaire, and 3) if you consent, complete the online screening questionnaire to determine whether you are eligible to attend an in-person screening visit to determine final main study eligibility.
STEP 1 - STUDY OVERVIEW:
The purpose of the Stanford University Keto-Med Trial is to investigate the effects of a Well-Formulated Ketogenic Diet versus a Mediterranean-Plus Diet in individuals with type 2 diabetes and prediabetes on glycemic control (as assessed by HbA1c), body weight, cardiovascular risk factors, immune function and inflammatory markers, and the gut microbiome.
This is a cross-over study design, meaning that all participants will participate in a diet sequence consisting of two phases: the Well-Formulated Ketogenic Diet, which will consist of participants consuming an extremely carbohydrate-restricted diet for 12 weeks, and the Mediterranean-Plus Diet, which will emphasize consumption of healthy fats, legumes, fruits, whole grains, and vegetables for 12 weeks.
In-person screening (morning), orientation (evening) visits, as well as seven health education classes (evening) with a registered dietitian will all be held at the Stanford Prevention Research Center (SPRC) at 1070 Arastradero Rd, Palo Alto, CA. This is also where you will pick-up all study materials and drop-off your collected stool samples. In addition, you will be asked to attend seven morning clinic visits at the Clinical and Translational Research Unit (CTRU, 800 Welch Road, Stanford) for fasting blood draws and vitals.
Seven times throughout the study, you will be asked to do the following: collect stool samples, complete three unannounced 24-hour dietary food recalls via phone with a trained diet assessor, complete online questionnaires to assess your health and well-being.
Prospective participants must live or work within close proximity to Stanford to accommodate these visits.
TIME INVOLVEMENT:
This online screening questionnaire will take about 20 minutes to complete.
If you are eligible and decide to participate, the entire study will take approximately 8 months to complete.
RISKS AND BENEFITS:
There are risks, discomforts, and inconveniences associated with any research study. These deserve careful thought. You should talk with the Protocol Director if you have any questions.
There are three possible risks of physical well-being:
1. Patients with type 2 diabetes on certain medications could become hypoglycemic (eg: low-blood sugar) on the ketogenic diet. In order to address this, our Health Educator (Certified Diabetes Educator) and Study Physician will monitor participants on a regular basis to ensure medications are adjusted as necessary. You will be given a glucometer to measure your glucose and ketone levels at any time. You will be taught how to use and maintain this device.
2. The ketogenic diet is high in saturated fat which could increase an individual's LDL-C and is possibly deleterious for the microbiome and inflammatory status. However, the nature of the ketogenic phase of this study is very brief (12 weeks) and should not result in any long-term lasting negative side-effects.
3. Blood sampling will be done by inserting a needle into a vein and or starting an I.V. which may cause some discomfort. It carries the risk of infection; however, the probability of infection occurring is slight. In addition, there may be some bruising and or bleeding which could occur as a result of the blood sampling.
Traveling to study appointments may cause inconvenience.
There may be additional unforeseeable risks to participating in this study.
The benefits, which may reasonably be expected to result from this study, include a wide range of information about your physical health and gut microbiota, as well as the results of tests and health education classes at no charge.
We cannot and do not guarantee or promise that you will receive any benefits from this study.
PAYMENTS:
You will not be paid to participate in this research study. Parking on campus is free of charge, and the study does not reimburse for travel. You will receive approximately 4-8 weeks of food at no charge throughout the duration of the study.
PARTICIPANT'S RIGHTS:
If you have read this form and have decided to participate in this project, please understand that your participation is voluntary and you have the right to withdraw your consent or discontinue participation at any time without penalty or loss of benefits to which you are otherwise entitled. The alternative is not to participate.
You have the right to refuse to answer particular questions. The results of this research study may be presented at scientific or professional meetings or published in scientific journals. Your individual privacy will be maintained in all published and written data resulting from the study.
Identifiers might be removed from identifiable private information and, after such removal, the information could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from you.
If after reading this, you are interested in participating in this study, please continue to step 2 below to consent to answer some questions to see if you qualify.
STEP 2 - CONSENT TO BE SCREENED
The purpose of this screening questionnaire is to determine if you are eligible to attend a clinical screening visit where final eligibility for the main study will be determined. Another purpose is to find out if you would like us to keep your contact information so we can let you know about future studies, or if you would like us to destroy your contact information and not be contacted about future studies.
The risk to taking part in this screening questionnaire is very small. The screening questionnaire is not designed to ask you for sensitive personal information, but it is possible that some people may feel uncomfortable answering these questions. If you qualify to take part in the study and are interested in taking part, then your name and information will be recorded; this will be kept confidential, but there is a small risk that people outside of the research team could learn this information. This survey is encrypted for additional security. If you are not interested in the study, then the personal information you have provided will be destroyed.
The benefit to you of taking part in this interview is that you will find out whether you can take part in the study.
If you do not want to answer these questions, you can choose to stop participating at any time by simply exiting the survey.
You will not be paid for answering questions in this screening since it is only to see whether you qualify to take part in the study.
CONTACT INFORMATION:
Questions: If you have any questions, concerns or complaints about this research, its procedures, risks and benefits, contact the Protocol Director, Christopher Gardner, PhD at (650) 725-2751.
Independent Contact: If you are not satisfied with how this study is being conducted, or if you have any concerns, complaints, or general questions about the research or your rights as a participant, please contact the Stanford Institutional Review Board (IRB) to speak to someone independent of the research team at (650)-723-5244 or toll free at 1-866-680-2906. You can also write to the Stanford IRB, Stanford University, 3000 El Camino Real, Five Palo Alto Square, 4th Floor, Palo Alto, CA 94306.
Please print a copy of this page for your records.
After reading the above information, do you consent to continuing with the screening questions?
If you agree to participate in this research, please: click Yes below, continue to the next page and start STEP 3, the Online Screening Questionnaire.