a study on Polycystic Ovarian Syndrome
Polycystic ovary syndrome (PCOS) is a syndrome which includes elevated androgen levels, irregular menstrual cycles and insulin resistance. Standard treatments, which include weight loss and medications to improve insulin secretion are only partly successful, and may require that young women take medications for decades. The study investigators have been evaluating the effects of specific diets on insulin resistance in healthy volunteers and subjects with type 2 diabetes, and have found that subjects with insulin resistance seem to respond particularly well to these diet regimens. Volunteers with PCOS are being asked to participate to see if following these diets can help regularize your menstrual cycles. The results of this study may help improve fertility treatments for women with PCOS.
PALEOLITHIC VS Healthy ADA DIETS FOR TREATMENT OF POLYCYSTIC OVARIAN SYNDROME (PCOS)
Experimental Design and Methods This is a prospective, open labeled, randomized diet intervention study done on adult participants with PCOS. After signing informed consents, participants will be asked to eat a recommended ADA diet for two weeks (run in period). Participants will then have baseline testing, including: urine and blood tests to evaluate insulin resistance (fasting glucose and insulin, 2 hour oral glucose tolerance test), electrolytes to assess acid-base status, ovarian volume and testosterone levels measured to assess severity of PCOS, and questionnaires about menstrual frequency, eating habits and stress. Participants will then be randomized to either a high fruits and vegetable Paleo Diet for 8 months or a standard ADA-recommended diet for the first 4 months followed by Paleo Diet for 4 months. All testing will be repeated at 4 months (crossover point) and at completion of the diets at 8 months. The primary outcome variables are menstrual cycle frequency and ovarian volume, and secondary outcomes include metabolic profiles and eating/behavior questionnaires
After 16 weeks, the participants in the ADA arm will be changed over to the Paleo arm. They will also require a "ramp-up" phase for 1 week. In our previous studies, we have seen a crossover effect at one month going from the Paleo to the ADA diet, but not from the ADA to the Paleo arm.
We will give all participants pertinent websites and written information about their specific diet, as well as sample menus. We will give participants in the Paleo arm a list of foods to avoid (e.g., dairy, grains, legumes, processed foods).
The main obstacles to compliance with outpatient diets include the cost, the amount of time needed, and ignorance about where to get specific kinds of foods. We will give them lists of various supermarkets and farmers markets times and dates, we will advise participants about making up batches of foods on the weekends and freezing them, and if they have families or other support, we will try to get them involved in support.
We have recruited four nutrition student volunteers from UC Berkeley, who will work closely with the participants to help them adapt the study diets to their everyday living situations. The nutrition students will help design the materials we will give the participants, as well as give dietary advice. We are working on a number of electronic and social media methods for keeping track of what our subjects are eating. These include:
We will also develop a secure website so that participants from each group can discuss with others what problems and solutions they are using.
Last, we will also assess 24 hour urines for creatinine, sodium, and potassium at 0, 16 and 32 weeks. Both of these diets will be higher in potassium and lower in sodium than typical American diets. Although we expect our subjects will be motivated enough to follow these diets, from our previous studies we have found that some subjects were not honest about what they were eating, and this was reflected in the 24 hour urine excretion of potassium and sodium.
Samples will be drawn at time 0; week 8; week 16; week 24 and week 32. We will collect serum, plasma and urine at all these timepoints for banking. The following tests will be performed at time (table 2):
Subjects will undergo assessment of 1)SHBG and androgen levels: total testosterone, androstenedione and DHEAS; 2) clinical hyperandrogenism: hirsutism by modified Ferriman-Gallwey and acne scores; 3) menstrual cyclicity (cycle interval and pattern); and 4) ovarian morphology (follicle count and ovarian volume).
Androgen levels (times 0, weeks 16, 32): Two serum samples will be obtained 30 minutes apart.. Serum will be isolated and aliquoted for future analysis of androstenedione (A), testosterone (T), DHEAS, 17 hydroxyprogesterone (17-OHP) and SHBG.
Clinical hyperandrogenism: The presence and extent of hirsutism will be determined using a modification of the Ferriman-Gallwey (FG) scoring method while acne will be scored according to the American Academy of Dermatology .Subjects will be requested to avoid any mechanical treatment for hair removal for 4 weeks prior to the baseline visit and to list all such treatments that are utilized during the study and their frequency.
Menstrual cyclicity: Menstrual frequency will be assessed as a menstrual frequency ratio as described by Elkind-Hirsch so that menstrual events are normalized to the normal interval of 12 menses per year (MFR=1.0) or, for instance, those with 6 cycles per year would have an MFR of 0.5.
Ovarian morphology: All subjects will undergo a transvaginal ultrasound (TVUS) to obtain an antral follicle count at baseline, 8 and 16 weeks. The study investigator will image both the left and right adnexal areas in two planes, and make measurements of the transverse, longitudinal, and anteroposterior diameters of each ovary using electronic calipers on a Shimadzu SDU-450XL machine with a variable 4-8 mHz vaginal transducer. The examination of each adnexa will ensure an adequate opportunity to locate the organs. Inability to locate adnexa in this age group is less than 1% (internal data). All echo-free structures in the ovaries will be regarded as follicles. Follicles with a mean diameter (of two dimensions) between 2 and 10 mm will be counted. Calculation of all follicles (2-10mm), as well as those 2- 5mm, will be possible as these numbers will be recorded separately. The total between the two ovaries (2- 10mm) will be considered the AFC. The volume of each ovary will be calculated by measuring the three perpendicular diameters and applying the formula for an ellipsoid: (L x H x W x π/6). Data will be entered directly onto scannable datasheets. Examination will also determine whether cysts/other abnormalities exist and provide images to document number and type of abnormalities. Clinical alerts will be generated for ovarian cysts of greater than 3cm diameter or solid adnexal masses of any size. Dr. Huddleston will be responsible for relaying information about clinical alerts to patients and physicians.
j. Questionnaires: Participants will complete the following questionnaires per the schedule specified in Table 1. Questionnaires tap psychological experience, health and eating behavior, and adherence.
Polycystic Ovarian Syndrome PCOS insulin sensitivity paleolithic diet
Open to females ages 18 years to 40 years
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02190097.
© 2017 The Regents of the University of California